The Journal of ProFormance TM Monitoring

Transcription

1 The Journal of ProFormance TM Monitoring healthmark INDUSTRIES CO. health care products

2 The Journal of ProFormance TM Monitoring Featured Authors About this Journal The Journal of ProFormance TM Monitoring is compendium of articles which have appeared in various leading industry publications and web sites. These articles have discussed the importance of cleaning in the successful reprocessing of surgical instruments and have analyzed various methods for monitoring the cleaning processes employed. The authors of these articles are long term participants in the sterile processing industry, both from a vendor and a user perspective. The wealth of knowledge they bring to this critical area of infection prevention is willingly and enthusiastically shared with readers of this Journal in the hope that shared knowledge will lead to shared success in reducing cross contamination, increased worker safety and better patient care. The Journal of ProFormance TM Monitoring is available in both an electronic form (as a PDF document) or in hard copy. The publishers of this Journal hope that readers will gain insight and inspiration and will share their experiences and practices in insuring proper cleaning. For feedback, healthmark@hmark.com or call x6615 and leave your comments. Stephen M. Kovach is the Director of Education for Healthmark Industries. He has worked in the hospital field for more than 30 years. For the last 18 years he has held various positions dealing with central service. He also has been an instructor at the community college level and published many articles on various health care subject matters. Denise Coatsworth, RN, BBA, is the former CS Manager at Botsford General Hospital in Farmington Hills, MI. Her department won the 2005 CS Department of the year from the Michigan Central Service Professionals. She has worked in the OR as well as in material management before becoming the CS manager in Kurt Browne has been active in the Central Service field for over 15 years. He has served as President of the Michigan Society of Central Service Professionals and was most recently the Chief of SPD at the V.A.M.C. in Ann Arbor, MI. Martin Pfeifer is the Managing Director and Founder of Pereg. He is the inventor of the TOSI, Sono- Check, HemoCheck and other products for monitoring the cleaning process. Ralph Basile is the Vice President of Marketing for Healthmark Industries Co. He has over 20 years experience in the development and marketing of products and solutions for the Sterile Processing industry. He is a member of AAMI, ASTM and the CSA. October 18, 2006

3 Take Control of the Cleaning Process Table of Contents 4 How Do You Know Your Automatic Washer Is Safe? by Stephen Kovach (appeared in Infection Control Today 2006) 10 Role of Water Temperature in Cleaning by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) 13 The Qualities of Water by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) 16 Mechanical Factors Contributing to Failure by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) 19 Assessing the Cleaning Process by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) Test for Cavitation in Ultrasonic Cleaners with SonoCheck TM Test and document water qualities with AquaChek TM ph Hardness Alkalinity 21 Measuring Clean in Central Service by Ralph Basile, Kurt Browne & Stephen Kovach (appeared in Managing Infection Control 2003) 26 Competency for Weekly Testing of the Automatic Washer Process (Keep all information in employee educational file). 30 Suggested Policy for Monitoring the Cleaning Efficiency of an Automated Instrument Washer/Disinfector Process Using the T.O.S.I. Blood Soil Test (Weekly Testing / Daily Inspection) Monitor and D o c u m e n t Water Temperature with Tempachek TM irreversible thermometers 35 Validation of TOSI Test Object Surgical Instruments for the Monitoring of the Cleaning Efficiency of Washer-Disinfectors by Martin Pfeifer 40 Improving the Quality of Your Sonic Cleaning Process by Stephen Kovach (appeared in Managing Infection Control 2006) 50 The Importance of Tray Selection to the Ultrasonic Cleaning Process by Stephen Kovach and Denise Coatesworth (appeared in Managing Infection Control 2006) 56 ASTM Publishes New Guideline: D7225 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors by Ralph J. Basile (appeared in Managing Infection Control 2006) 60 On Borrowed Time: Caveat Emptor with Loaner Devices by Stephen Kovach (appeared in Healthcare Purchasing News 2006) Test the Results of the Cleaning Process With ProFormance TM Test Surface Cleanliness with a protein detection device healthmark INDUSTRY COMPANY healthcare products

4 How Do You Know Your Automatic Washer Is Safe? by Stephen Kovach (appeared in Infection Control Today 2006) Imagine this scenario. A Joint Commission surveyor asks a Central Service Manager, How do you know your automatic washer is working properly? The CS manager replies, My instruments look clean. It is no longer uncommon for such a question to be posed of CS staff. Central Service has become one of the hospital s most highly technical areas. Professional organizations that set guidelines and standards for central service (AAMI, JCAHO, FDA, CDC, etc.) have begun to focus on verifying and monitoring the cleaning process, and on implementing Quality Improvement Programs (QIPs.) Their guidelines pertain to ultrasonic cleaners and automatic washers. The following paragraphs outline the various regulatory organizations guidelines concerning monitoring the cleaning process. Central service professionals can use these guidelines to answer questions such as: How do I know my automatic washer and ultrasonic cleaner are working properly? What am I doing to ensure that these machines are working the way they are intended to? How do I ensure that these machines are rendering items clean and safe for handling by staff and ready for use on a patient? JCAHO Darlene Christiansen, Director of Standards Interpretations and the Office of Quality Monitoring for JCAHO, states, Sterile Processing is an integral part of the care process, so it s important to assess that equipment is being properly maintained, chemicals are being used properly, infection control and (safety) measures are being applied appropriately and that there is proper ventilation, for example. Two new JCAHO standards support Christiansen s assessment. Standards EC.6.10 and EC6.20 require organizations to manage the risks of medical equipment and that equipment be maintained, tested, and inspected on a prescribed basis. These standards require the organization to have a written plan in place. AAMI The Association for the Advancement of Medical Instrumentation (AAMI) is the primary resource for domestic and international standards for the medical industry, medical professions, and government. AA- MI s revised TIR 12:2004, 2nd Edition Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for device manufacturers is an excellent resource for identifying the questions health care professionals should ask manufacturers when considering a product for purchase or when devising a reprocessing protocol for a product already being used. This new document is the most proscriptive thus far when it comes to the monitoring of the cleaning process. It directs device manufacturers to provide not only specific instructions on how to clean their surgical instruments, but also how to verify that proper cleaning has occurred. Suggestions include monitoring water temperature for proper cleaning and disinfection, employing a specific method to test the cleanliness of an instrument, or using a suitable analogous device to verify the effectiveness of the cleaning process. Central Service professionals should k n o w t h a t 4 October 18, 2006

5 AAMI ST Effective cleaning is a multistep process that relies on several interdependent factors: the quality of the water; the quality and type of detergent; an acceptable washing method; proper rinsing and drying; correct preparation of items to be processed by cleaning equipment; the time and temperature parameters and load capacity of the equipment; and operator performance Cleaning agents Many types of soil could be present on reusable medical devices, but dried blood is especially difficult to clean. As a liquid, blood tends to flow over and into joints, hinges, grooves, and other difficult-toclean locations. It then coagulates and dries to create a significant challenge to cleaning Verification of the cleaning process. There is an increasing awareness in sterile processing of the need to control and standardize the steps taken to ensure a sterile device for patient use. With the understanding that disinfection and sterilization cannot be ensured unless the cleaning process is successful, it is incumbent upon professionals in the field to seek out whatever means are available and practical to verify this function. A quality system would call for the decontamination processing parameters to be monitored and documented, whether the process was accomplished by hand or mechanically. 9.2 Quality process Measurements of process performance allow the system to be monitored and the results compared to a predetermined level of quality. Evaluation of the findings provides a method of identifying problems or shifts in activities, and facilitates informed decision-making on policies and procedures. Ongoing auditing provides data to assess the effectiveness of the process and make ongoing improvements in performance. not only does the TIR 12 document direct manufacturers, but also by inference, it empowers the hospital Central Sterile Service department to insist on receiving proper and complete decontamination documentation for each and every instrument. The revised AAMI standard ST 35, 2003 (decontamination document) recognizes the need for testing and the importance of having a quality process in place when it comes to cleaning. FDA The FDA document Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff states, The FDA believes that a safe and effective system for cleaning and disinfecting medical devices is important in protecting the public health. (February 7, 2002) Continued, Is Your Washer Safe? The Safe Medical Device Act of 1990 states that each institution must have processes in place for identifying and implementing the reporting of incidents related to equipment failure. Equipment that fails or is taken out of service must be reported and documented. Failure of an automatic washer certainly warrants documentation and follow-up. CDC Currently the CDC is reviewing its Guideline for Disinfection and Sterilization in Healthcare Facilities. The final guideline will be published following revisions. The CDC s current recommendations can be found at its Handwashing and Hospital Environmental Control page: Cleaning is the necessary first step of any sterilization or disinfection process If the surface is not cleaned before the terminal reprocessing procedures are started, the success of the sterilization or disinfection process is compromised. Industry / Companies Companies are beginning to supply users with information on how to test their automatic cleaning equipment. For example, in May of 2005, Smith & Nephew updated its Cleaning and Sterilization Guide for Orthopedic Instruments on their web page. The new user guide includes the following recommendations: The quality of water should be carefully considered for use in cleaning reusable devices. Water hardness is a concern because deposits left on medical devices may result in ineffective decontamination. The use of deionized water will reduce the mineral deposits on the devices. Ultrasonic Cleaners should be monitored routinely to ensure that 5

6 Continued, Is Your Washer Safe? they are working properly. Recommended monitoring methods include: 1) Sonocheck monitoring vials (from Healthmark Industries Co., East Nine Mile Road, St. Clair Shores, MI USA) which change color when the ultrasonic cleaner is supplying sufficient energy and conditions are correct. The Getinge Company also has developed a performance-monitoring program that allows users to independently verify the key parameters of the automatic cleaning equation under their control. On the subject of verifying the cleaning process, Linda Clement and Heide Ames of Steris Corporation states, Now you must investigate the entire sterilization process, beginning with cleaning: a) verify that the washing equipment is working properly (spray arms aren t obstructed and water heating element isn t malfunctioning, for example); b) verify that the washing equipment monitoring devices are functioning correctly; c) ensure that all cleaning chemistries used in the washer are appropriate for the equipment and the devices being processed, and that they are being dispensed correctly. WHY TEST? Regulatory agencies and industry are promoting the implementation of Quality Improvement Programs to monitor the cleaning process. Even with the advent of such guidelines, some people question the need to monitor. The following real-life examples illustrate why hospitals should implements QIPs for their automatic washers and sonic equipment. Switched at Birth A CS manager implemented a cleaning QIP, which included the use of a standardized blood soil test. The failed test result, which included residual blood soil on the stainless steel coupon, indicated that water temperatures were not correct for the various cycles. Upon investigation staff discovered that the washer had been installed 10 years prior with the cold and hot water delivery pipes reversed. This resulted in excessive pre-wash temperatures for the equipment cycle setting. After the problem was corrected the washer was again tested and received a passing mark. How to Save Detergent Shortly after switching brands of detergents for their automated washers, staff at one hospital reported a blood odor in the machine after the cycle was complete. The staff followed the recommended QIP, including use of a standardized blood soil test. They determined that the new detergent had produced excessive sudsing and that the detergent concentration had been set to nearly zero. Although this certainly would have saved the hospital a great deal on its detergent budget, the instruments were not getting clean. I m Melting After implementing a new QIP program for the automated washer, a C.S. Department quickly discovered that a plastic supply line for the detergent had for a period of time been in contact with a non-insulated portion of the hot water line. The tube had melted closed, completely eliminating detergent supply to one of the washers. No one knew how long this condition had been in place. An Expensive Soaking Tank A hospital s sonic cleaner looked and sounded like it was functioning properly. But when staff used a new test designed to detect cavitation energy, the sonic cleaner failed. A follow-up visit by an independent service company confirmed that the transducers were not working. No one in CS knew how long the cleaner 6 October 18, 2006

7 Continued, Is Your Washer Safe? had been malfunctioning; they had simply let the machine run longer (sometimes up to 15 minutes) until they felt the instruments were clean. True Confessions from the Author In my own experience as C.S. Manager I have seen the need for monitoring the cleaning process. In one case I was using a different detergent than what my washer company required. After visual inspection we determined that the instruments were not clean. The washer company blamed the failure on our use of the wrong detergent, but the detergent company defended its product. All I had was a visual assessment; I had no independent test that could determine why my instruments were not as clean as they had been before. Eventually we discovered it was a dilution problem, but only after a lengthy, frustrating investigation that could have been avoided had we had a proper test. I had a similar experience loading trays in my automatic washer. The hospital where I was working had a problem processing trays the C.S. department was very busy and the decontamination area kept backing up. A representative of the equipment company told me to doublestack the baskets that the machine could handle it. He also told me I could put the trays in without rinsing them, which would speed up the process. After running about five loads this way my staff informed me that the instruments were not getting clean. We immediately stopped this process. Had I taken the time to learn more about how my equipment worked and the impact of all the factors of the cleaning process I could have solved my problem more easily and with less frustration. At that time I not only lacked education and training, I had no real method for monitoring my cleaning process. Rising Tide of Concern Concern is growing over the effectiveness of decontamination techniques for reusable instruments in healthcare facilities. These techniques have a direct impact on patient outcomes. Studies have shown the ability of sterilization technologies, which under normal conditions achieve acceptable sterility assurance levels, to be greatly impaired by the presence of residual soil containing serum and salt. Residual organic debris on processed surgical instruments is a concern, and visual inspection is not a 100% accurate. The best way a medical facility can determine whether its equipment is working properly is to implement a quality improvement program. The QIP should be used daily and after equipment is installed or relocated. It should also be used after a machine malfunctions, a process fails, or any major repair is made on the equipment. The QIP should include, but not be limited to, daily inspection of equipment (cleaning screens, spray arms, interior of the chamber, etc.), testing via a blood soil type test, and continuous Cleaning in the Headlines These examples illustrate the frustration C.S. Mangers experience when cleaning instruments. This is not a new problem, nor has it gone unrecognized by the public. The following news headlines appearing over the past few years attest to public concern about monitoring the cleaning process: The process of sterilization should not replace the process of cleaning. Soil is still soil, even though it may have been sterilized. The quality of reusable equipment depends on the reliability of cleaning and sterilizing procedures. Inadequate cleaning of medical or dental instruments can threaten the sterilization process. Surgery halted over dirty instruments, in England. North Carolina surgeons unwittingly used dirty tools. In order to sterilize medical devices effectively, all organic debris (e.g. blood, tissue and other bodily fluids) have to be removed from the item prior to disinfection and/or sterilization. 7

8 Continued, Is Your Washer Safe? staff training. The Future Central Service Professionals need and are receiving support from regulatory agency guidelines to implement quality improvement programs for monitoring the cleaning process. Yet still we must answer to the public, who read the headlines and ask, How do you know your instruments are clean? Likewise we may have to answer to a JCAHO surveyor who, as in the opening of this article, asks, How do you know your automatic washer is working properly? It is my experience that if you ask 10 Central Service managers what sterilization parameters they use, all 10 will respond, 273 degrees F for 4 minutes. When you ask about the parameters used for cleaning, however, you are lucky if 50 percent know the answer for their equipment. This lack of knowledge makes it very difficult to optimize the cleaning process. Quotes from the Front Lines Many CS professionals are already taking steps to monitor the cleaning process. These individuals responded as follows when asked the original question, How do your know your washer is working properly? Penny Sabrosky, a Senior Manager at Spectrum Health: We currently use the product TOSI to test the efficacy of our washer units on a weekly basis and when we discover problems with unusual soil, or rinsing problems. We recently signed up for a preventative maintenance program from the manufacturer of the equipment and receive quarterly maintenance and service upon request for breakdowns. Typically we would run a TOSI test after the service is performed for verification of the maintenance. Betty Strickland, Director of Materials Management, Christus St Joseph Hospital: I use the TOSI daily. Nyla Japp of Banner Health: I know my automatic washer is safe to use because I validate my cleaning process in every washer once a week and following any needed repairs. I do this by a process called TOSI cleaning effectiveness indicators. I log the results as to whether or not they pass or fail this challenge. If they do not pass this challenge, the washer manufacturer is called in for repairs and the washer is taken out of service until it successfully passes the TOSI challenge. Denise Coatsworth, Manger of Central Service at Botsford General Hospital: (This question) can sure open up a can of worms. I don t believe a visual inspection of instruments defines cleanliness because cleanliness can be subjective. As a manager, I would look to CSP organizations to establish standard protocols for what conditions and testing determine a clean instrument. An instrument may appear clean once it comes out of the washer, but is there any way that the appearance and condition of that instrument can be Managers Speak Out About Cleaning Penny Sabrosky: We currently... test the efficacy of our washer units on a weekly basis Denise Coatesworth : (This question) can sure open up a can of worms. Betty Strickland: I use the TO 8 October 18, 2006

9 Continued, Is Your Washer Safe? SI daily. improved? We also want to ensure that the instrument is safe for handling. As we know, an instrument cannot be determined sterile unless it is clean. Standard protocols have been established and written for our institution and, a routine quality test must be run weekly to maintain and document the quality of the wash cycle. The TOSI test is an easy and reliable test for the wash cycle, but once that test is run and obtains less than optimum results, as the manager I must then be willing to take action to get the washer to the optimum level. In good conscience, I could not run the test, obtain less than optimum results, and then take no action. Nyla Japp: If they do not pass this challenge,... the washer is taken out of service John MacDougall, R.N., Manager Central Sterile Supply at Sparrow Hospital (HPN, December 2004): These washers are the first line of defense for fellow staff members, patients and physicians to ensure they are receiving clean instruments before they wrap and sterilize them. Commercial monitoring products are going to be critical in helping to support the process we use. We need to ensure that when asked by the surveyor How do we validate that your washer is working properly we have an answer, including testing to demonstrate a consistent practice and supporting documentation. In Conclusion The importance of monitoring the cleaning process is just starting to gain acceptance in the industry. Many healthcare professionals feel it is important to have a QIP to help them better understand their cleaning process and to provide a quality cleaning outcome at their institution. The following quotations summarize why Central Service departments should monitor their cleaning process. A problem analysis should be completed for any problem with any aspect of decontamination that can pose a risk to personnel or patients. The problem analysis should define and John MacDougall: These washers are the first line of defense... 9 resolve the problem and the system should be monitored to ensure that the problem has been corrected. Cleaning, not sterilization (or disinfection) is the first and most important step in any instrument processing protocol. Without first subjecting the instrument to a thorough, validated, and standardized (and ideally automated) cleaning process, the likelihood that any disinfection or sterilization process will be effective is significantly reduced. Ensuring safety and quality is an active practice, not a passive one. Isn t it time for everyone to understand and monitor the cleaning process? When monitoring -- whether manual or automatic -- occurs, the winners are both patients and staff Hospital Purchasing News, June 2004, page 32. Joint Commission on the Accreditation of Healthcare Organizations Standards for Accreditation, Environment of Care Standards EC.6.10,EC6.20. JCAHO, Oakbrook Terrace, IL, Food and Drug Administration. Center for Device and Radiological Health, Safe Medical Device Act of pdf, page 72 page 41, HPN, September 2005 The Central Service Technicians Training and Supervision ; IAHCSMM 1975 Leon Hirsch, Chairman, ES Surgical, Wall Street Journal, April 1993 Janet Prust, Technical Services Supervisor, 3M Health Care London Daily Telegraph, ISSUE 2003 Saturday 18 November 2000;By Celia Hall, Medical Editor 0. surgery-nc_x.htm. pelican-report.html Report No: 00/1192/1, Revision: 1.20, November 200. Alfa,M.,et al, Comparison of Ion Plasma, Vaporized Hydrogen Peroxide, and 100% Ethylene oxide Sterilization to the 12/88 Ethylene oxide gas Sterilizer, Infection Control and Hospital epidemiology, 1996; 17: AORR Journal; July 1995,Vol62, NO1;DesCoteaux, Poulin, Julien, Guidoin page 23, Section 9.2 ANSI/AAMIST (k) Summary and Overview ; Safety, Efficacy and Microbiological Considerations,. The System 83 plus Washer -Disinfector; Custom Ultrasonics, Inc,1998,page 7

10 Role of Water Temperature in Cleaning by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) This is the first in a series of 3 articles where we will discuss critical aspects of the cleaning process. Our effort is not meant to be exhaustive, but is meant to highlight critical issues often overlooked or inadequately understood in the cleaning process. This first article will discuss the role of temperature in the cleaning process. The second article will focus on the important qualities or characteristics of the water used in cleaning. The final article will review the key mechanical factors that often contribute to a failure in the cleaning process. The Role of Temperature in the Cleaning Process Hotter is Better. This might be the motto for proper water temperature in the cleaning process. Except that this would be wrong. How about this: Get the temperature right. The proper water temperature is different for each type of cleaning and for each stage of cleaning. What is proper also varies with the cleaning agent (e.g., enzyme cleaner, detergent) used. Are you using the right temperature at each stage? With this article, we will try to give you some guidelines and also suggest where to go for definitive answers. Water Temperature Principles in Cleaning Here are some important statistics to keep in mind when cleaning: 1. At higher temperatures, the molecules of water and other solvents are more active. As a result, the cleaning action of these agents is better. 2. Blood denatures at temperatures above 45 o C (113 o F). When blood denatures, it become highly insolvent. It bonds strongly to the substrate (e.g., the surface of instruments) and it dries out becoming very resistant to the action of solvents. 3. Enzymes are proteins. Like other proteins, enzymes consist of long chains of amino acids held together by peptide bonds. As such, enzyme cleaner performance is significantly influenced by environmental factors including temperature. There are many types of enzymes that are used for cleaning. Prepared enzyme solutions are complex and unique. It is impossible to make a blanket statement about the ideal temperature for all enzyme cleaners. Only the manufacturer can provide this information. Be aware of a couple of things: First, most protease enzymes are destroyed at temperatures above 140 o F. Second, all enzymes operate best in an optimal temperature range. Outside of this range, enzymes lose their effectiveness. The further from the optimal (hot or cold) the greater the loss in effectiveness. The lifespan of enzymes is heavily influenced by storage temperature. Above 37 o C, most protease enzymes rapidly expire. 4. Detergents, like enzymes also work most effectively in an optimal temperature range. Again, this range varies between brands of detergents and only the manufacturer can supply this optimal temperature range. Generally, detergents used during the wash cycle of an automated washer work best around 150 o F. For the optimal range for the detergent you are using, check with the manufacturer. 5. The key method for disinfection employed by modern washer - disinfectors is thermal disinfection. Currently, in the United States no Government or Industry organization specifies a required level of the time & temperature for disinfection. The proposed standard in Europe (EN ) has a specified a temperature of 90 o C for 1 minute for high level disinfection. High level thermal disinfection also occurs at 80 o C for 2 minutes. Not all washers are designed to deliver a high level of disinfection. Some make no claim for disinfection, and others claim low or mid level disinfection. Check with the manufacturer for the target temperature for thermal disinfection in your washer. Also, keep in mind; the temperature for disinfection is surface tempera- 10 October 18, 2006

11 Demonstrate Thermal Disinfection with TempaChek TM -DL Role of Water Temperature, Continued TempaChek TM -DL data logger is the first affordable device that is capable of independently capturing, logging and recording the complete temperature profile of an Automated Instrument Washer including thermal disinfection. The TempaChek TM -DL is easy to use. First, connect the USB reader to a desktop computer, insert the TempaChek TM - DL, program the logger to begin recording at a prescribed time. When ready to record, place the datalogger within a basket insider the Washer. At the the end of the cycle, replace the TempaChek TM -DL in the USB reader and download and save the captured temperature data. In addition to disinfection, the datalogger also provides a complete log of surface temperatures throughout the cleaning cycle. ture. In other words, while the water injected into a washer may be at the target temperature, this does not mean that the surfaces of instruments are reaching these temperatures. 6. Thermal disinfection is delivered by water. The drying cycle in a washer which may reach temperatures in excess of 210 o F, is not a source of thermal disinfection. Applying the Principles: Soaking Manual soaking and soaking with the mechanical assistance of an ultrasonic cleaner usually involves the use of enzyme cleaners. The manufacturer of the cleaner you are using must supply the optimal temperature. Typically, the optimal temperature for these cleaners is 90 o o F. But, this may not apply to your cleaner. Typically, as well, at temperatures above 140 o F, these enzymes are destroyed. Often the labeling on these cleaners specifies a maximum temperature of 140 o F (or some other) but does not provide an optimal range. Instead, the labeling specifies warm water. But warm is highly subjective. Insist upon a specific temperature range from your supplier. The further away the enzyme cleaning solution is from the optimal, the less effective it will be. Applying the Principles: Automated Instrument Washers The pre-rinse or cold water rinse of your washer should not exceed 113 o F and would be best if it was below 100 o F. The target range for many washers is 60 o - 90 o F. Make sure your machine is operating in its target range. This initial rinse is critical. Not only will it wash away most of the gross contaminants, making later stages more effective, but if set at too high a temperature, this rinse cycle may denature the blood soil to the point that later stages will have minimal effectiveness. Temperature is also a critical factor in the performance of the enzyme cleaner and detergent. Be sure you know what these temperature ranges are and that your machine is operating within this range. Also be aware that a change in supplier may necessitate a change in the settings for your washer. Finally, disinfection is a critical aspect of the decontamination process. Different Washers promise differing levels of disinfection and reach these levels with different temperatures at different time periods. Know the capabilities of your Machine and be sure to independently monitor the Washer s performance. Industry Standards While there are no specific U.S. based standards, AAMI does suggest the following in ANSI/AAMI ST35 - Section 9.2: performances measures should include, but are not limited to: correct loading.selection of appropriate cycle parameters ( time/temperature). ANSI/AAMI 11

12 Role of Water Temperature, Continued ST35- section 9.2e states it is essential that decontamination processing parameters be monitored and documented whether the process is accomplished by hand or mechanically. The proper temperature at each stage of the cleaning process is critical to the effectiveness of the process. It is important to know what the target temperature is and be able to accurately monitor and document that temperature. Other countries and continents have standards on the temperature of the water at each stage of cleaning. While those standards have not yet made their way to the United States, by working with the manufactures of detergents and equipment you can optimize the output of your process and put in place a quality process that meets world class standards. Go beyond what you can see and test the cleanliness of instruments with the HemoCheck TM Blood Detection Kit and Surfaces with the ProChek TM protein detection device. It is invisible to the human eye, but with the SonoCheck TM you can test for the presence of cavitation energy - the cleaning power - of your Ultrasonic Cleaner. Reveal the hidden areas of instruments (like box locks) with the TOSI TM automated washer test, the easy to use blood soil device that mimics the cleaning challenge of surgical instruments. healthmark INDUSTRY COMPANY healthcare products October 18, 2006

13 The Qualities of Water by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) Qualities versus Quality Why do we state qualities of water, rather than the oft phrased quality of water? It may be a symantic argument, but the point is that water has many qualities or characteristics, several of which are of importance to the cleaning of surgical instruments. Further, the singular quality implies an absolute, superlative state that is desirable in all circumstances. This is not the case. For instance, the best temperature quality varies from method of cleaning and the stage of cleaning of surgical instruments. The plural qualities implies a relative value that is desirable for a given circumstance. To make the point further, Charles Darwin, of Theory of Evolution fame, is often credited for the maxim survival of the fittest. This is typically interpreted as a superlative - meaning the strongest, or fastest or biggest will always succeed. But really what Darwin described was survival of the best fit ; the species best able to adapt and fit in to its environment will be most successful. Thus, the slow, plodding turtle is one of the oldest family of species on earth, out Temperature living millions of other faster, more dynamic competitors. In the same manner, we plan to describe qualities of water that best fit the cleaning task at hand. The first quality of water is its temperature. This issue is discussed in great deal in another article in this series and we refer you to this article for greater detail. To summarize briefly, water should be hot enough to maximize its solvent action, but not too hot to compromise the cleaning process. Key statistics to keep in mind: Blood denatures, becoming highly insolvent, when exposed to temperatures above 113 o F. This is an important issue for presoaking and for the cold-water rinse of washers. Enzyme cleaners operate best in an optimal temperature range (which can only be provided by the manufacturer of the enzyme cleaner used). Beyond this range, cleaning effectiveness will deteriorate. At too high a temperature, enzymes are destroyed. Detergents also work best in an optimal temperature range (again which can only be provided by the manufacturer). While destruction of detergent is not an issue, loss of effectiveness is a concern. Thermal disinfection by water is the primary agent of disinfection in modern washer-disinfectors. The temperature of disinfection is related to time. Under the proposed new European Standards (EN ) the accepted level for disinfection is 90 o C for 1 minute. There is currently no equivalent standard in the U.S. ph Enzymes Enzymes are a type of protein that increases the speed of chemical reactions. Enzymes achieve their effect by temporarily binding to the target soil and, in doing so, lowering the energy needed to remove it from the surface of the surgical instrument. Each type of enzyme has a unique shape that binds with a specific soil. All enzymes have specific optimum conditions (temperature, ph, etc.) at which the enzyme causes chemical reactions at the highest rate. Enzymes have a 3D shape that has to be intact for the enzyme to bind to the target soil. If the 3D shape is altered or destroyed the enzyme will not function. Bonds hold the 3D shape together and if these bonds are broken, the 3D shape is lost and the enzyme is denatured. Every enzyme has a ph level at which it works best - the optimum ph is where the highest reaction rate will occur. Above and below the optimum ph the number of reactions will decrease dramatically. 13

14 Continued, Water Qualities Cleaning factors - harshness versus effectiveness What is ph? It is the measurement of the concentration of hydrogen ions (shown in chemical notation as H+) in relation to the concentration of hydroxyl ions (shown in chemical notation as OH-). An excess of H+ (hydrogen) ions over OH - (hydroxyl) ions makes a solution an acid. Conversely, an excess of OH - (hydroxyl) ions will make the solution alkaline (basic). The ph scale goes from 0 to 14. At ph 7, the halfway point, there is a balance between acidity and alkalinity. Such a solution is neutral. Each unit on the ph scale actually represents a 10-fold difference in acid activity. Thus, a ph 9 solution is ten times as alkaline as a ph 8 solution. Detergents with low ph (acidic) are more effective for inorganic soil while high ph (alkaline) detergents are more effective for organic soils like fat or protein. Neutral ph agents are used for anodized aluminum or stainless steel surfaces that might be discolored or destroyed by acidic or alkaline detergents. Extreme levels away from neutral in either direction can dramatically reduce the life of instruments by causing pitting, staining and corrosion. On the other hand, an elevated alkaline level may be necessary to effectively remove organic soils in the short period of time that instruments are exposed to the detergent during the cleaning cycle in an automated washer. An elevated alkaline wash can be followed by an elevated acid rinse in order to neutralize the remaining wash, minimizing potential damage to instruments. Hardness Water Hardness is defined as the concentration of calcium and magnesium ions expressed in terms of calcium carbonate. These and other minerals bind with the cleaning agents in detergents and prevent them from reacting with the soil on instruments. The amount of hardness minerals and other dissolved solids in water present obstacles to good cleaning. Hardness minerals can cause spotting and filming on instruments. They must be effectively tied up or sequestered if the cleaning results are to be satisfactory. Methods for doing so can be as simple as increasing the amount of detergent used, to selecting detergents with higher levels of chelating agents which sequester hardness minerals or treating the water prior to use. In particular, it is often recommended (and may soon be part of European Standards for Washer - Disinfectors) for the water used in final rinse to be highly treated with complete or near complete removal of mineral contaminants. Methods for doing so include reverse osmosis. If reverse osmosis water is not practical, then de-ionized water or at least softened water should be used. The importance of the final rinse water cannot be overstated. Not only can the final rinse be a source of contamination, but also it is the last chance for removing contaminants from the surface of the instrument. To be most effective, the water needs to be best able to bind with remaining contaminants. Freeing the water from mineral contaminants helps to accomplish this. Alkalinity Alkalinity is the ability to neutralize acids. Total alkalinity is the total concentration of bases in water expressed as parts per million (ppm) of calcium carbonate (CaCO3). Total alkalinity is a measure of the buffering capability of water to resist changes in the ph level. It is desirable at every given level of ph, to have a high level of alkalinity. 14 October 18, 2006

15 Continued, Water Qualities Microbial Purity Introducing contaminants The goal of cleaning is to remove as much microbial and other contamination from instruments as possible. Obviously it makes little sense to use water that is rich in biological elements. There are currently no standards in the United States for the microbial purity of water used in washer disinfectors, ultrasonic cleaners or manual cleaning. In Europe, the proposed standards EN call for the use of very clean water (e.g., DI, sterile, etc.), though these standards do not mandate it. In the U.K. and Australia, the standards are also suggestive of the use of very clean water for use in the final rinse stage. There is an extraordinary exception to this in the U.K when it comes to the water used for the final rinse in thermal labile scope cleaners. It is mandated that this water be sterile (HTM2030)! It is necessary to weekly test the microbial quality of the rinse water. Further it is mandated that weekly the final rinse water also be tested after it has been used to rinse the scope! This is a method for testing the efficacy of the scope washer itself (e.g., has the cleaning process rid the scope of contaminants). Conclusion The primary vehicle for cleaning is water. There are several qualities of water that influence the effectiveness of the cleaning process. Too often in the past, these qualities have been ignored or misunderstood. In the future, monitoring, verifying and documenting these qualities of water will be mandated. Now is the time to take the steps as part of a total quality improvement plan to monitor, verify and document the qualities of water to insure the best possible cleaning process. Introducing the ProFormance TM (TOSI) Washer Test A New Era in Cleaning Surgical Instruments Sterile is not sterile, if clean is not clean. Failure to properly clean surgical instruments means that bioburden is "cooked" on to the instruments during sterilization - trapping contaminants where they can easily cause infection. Proper cleaning is critical - yet until now there has not been a device that consistently, and independently provided an objective test of clean. ProFormance TM (TOSI) is that device - the routine use of this test will insure that the Washer is performing at a consistent level each and every day. For more information or a demonstration, please contact Healthmark at or visit our web site at Test.com. 15 HEALTHMARK INDUSTRIES CO * FAX:

16 Mechanical Factors Contributing to Failure by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) With over a year of experience with the ProFormance TM standardized soil test, as well as years of experience in the Sterile Processing Profession, we have accumulated a lot of real world experience with washer - disinfectors. Many factors can contribute to a poor cleaning result. Previous articles discussed some of these factors. In this article we will address mechanical factors that can lead to failure. Incorrect Temperature Settings This was discussed in detail in the first article. But it bears repeating here, because this is such a common reason for failure. Most important is the cold temperature rinse. Too many times, the water used in this cycle is heated. It is crucial that the temperature not exceed 110 o F. Blood exposed to temperatures above 110 o F is cooked on to the surface of instruments instead of washed away. This creates an excessive challenge to the chemical additive cycles to remove the dried hemoglobin and obstructs the effort of these cycles to remove fibrin and other water insoluble contaminants. Proper temperature settings for the enzyme wash and detergent wash are also important. The manufacturer of these products can provide those settings for you. Finally, the thermal disinfection rinse temperature is important. Thermal disinfection by heated water is the key method of disinfection by modern washer - disinfectors. The level of disinfection and the target temperature for this cycle varies between machines, so check with the manufacturer of your washer for the target temperature. Improper Cycle Time We could in fact title this cycle times are too short. Often the pressure from the Operating Room is so great for turnaround of instruments, that time savings is sought from inappropriate areas. One such area is the cycle time of the washer. We cannot give you blanket times for each cycle. Only the manufacturer of your washer - disinfector can do so. But do not set cycle times at the minimum, if you expect instruments to come clean. A crucial stage in washing is the initial cold water rinse. Even though it is cold water and even though there is no added cleaning agent, this is the most critical stage in the process. This rinse stage is responsible for removing the vast majority of contaminants, including most of the hemoglobin. By removing these gross contaminants, this cycle clears the way for the wash stages with chemical additives (e.g., enzyme, detergents) to work on the water insoluble soils. In our ideal world, this cycle would last a minimum of 3 to 5 minutes. Spray Arms Spray arms play a vital role in wash- 16 October 18, 2006

17 Mechanical Factors, Continued ing. These arms, with their spinning action and multiple, widely dispersed nozzles which spread the rinsing and cleaning solutions throughout the chamber of the washer and all over the instruments. A number of things can compromise the effectiveness of spray arms. First is the result of human error: an object stacked in such a way that it physically blocks the arm, preventing it from spinning. Another source of problems are clogged nozzles. This can be caused by a number of factors, including excessively hard water. Nozzles should be checked frequently as part of a preventive maintenance program, to insure that this is not occurring. Finally, corrosion of parts can lead to spinning arms that are no longer spinning. If you are fortunate to have a washer with a window, you may be able to see arms not spinning. Of course, with any of these problems, a standardized soil test can help to identify problems. Spinner Arms out of Alignment In many washers the spray arms are connected to the spinning axle with a threaded end (e.g., they are screwed in). Though this connection allows for easy removal of the arms for cleaning and replacement, the arms can be reinstalled in the wrong direction. The fluid flow then comes out to the sides, instead of up and down, dramatically reducing the cleaning efficiency of the washer. One can easily check this visually and correct the problem fairly easily by simply turning the arms so nozzles are in the correct direction. Couplers out of Alignment While it may appear that there is plenty of water flowing through the nozzles, the nozzles are clear, aligned properly, and spinning correctly there could be one other water-flow failure. In many washers the rack that holds the baskets of instruments must connect to the washer through a coupler. This coupler is a key connection that allows fluid to reach the spinner arms and insure proper cleaning efficiency. Be sure to check to see if the couplers are connected and secure when the rack is in place. Metering of Cleaning Agents Modern washers are designed to automatically meter the cleaning agents (e.g., enzyme and detergent) into the chamber. Typically the volume of agent metered is not directly measured, but rather is inferred by the machine based upon operation time. Often users are not entirely aware of this. The source of confusion is understandable. Modern washers do provide an error message when the cleaning agent container runs empty. This is done with a separate float in the container. When the agent is gone, the float reports this to the machine which in turn reports this to the user. But, as long as there is liquid in the container, the machine will not provide an error message. If the tube to the washer becomes clogged, for instance, the machine will not report an error. Clogged tubes are a common problem. The nature of the detergents typically used leads to clogging. To avoid this problem, tubes should be periodically changed. Further, a method should be found to track 17

18 Mechanical Factors, Continued the amount of cleaning agent consumed. If each individual washer draws cleaning agents from a separate jug, a simple method would be to use a graduated container. Simply record the amount of soap at the beginning of the cycle and again at the end. For installations where multiple machines are drawing from the same container, digital totalizers combined with flow meters for each machine can be installed. Again, the amount of cleaning agent consumed per cycle can be recorded. Cavitation Ultrasonic cleaners work by producing ultra high frequency sound waves that cause micro explosions. These explosions generate very high pressure of water and also create ultra high temperatures. This combination helps to blast contaminants off of instruments. Of course, these micro explosions are not only incredibly small, but they are incredibly quick, so they are not observable by the human eye. The ultra high frequency sounds are generated by a series of transducers that are arrayed around the tank of the cleaner. The effective range of an individual transducer is limited and thus in a typical ultrasonic, several transducers are used. Like any mechanical device, from time to time, transducers fail. Given the nature of ultrasonic cleaning, observation of failure is not easy. Also, in a series of transducers, one may be failing, while the remaining units are functioning, creating dead spots within the ultrasonic. Monitoring devices for detecting cavitation are now commercially available. Conclusion Many factors influence the effectiveness of the cleaning process. This article has highlighted the most common mechanical reasons for failure. Often these problems can be corrected by Sterile Processing Staff without outside assistance. At the very least, they can be identified by Staff and reported to the Maintenance Vendor. Critical to identifying problems is utilizing methods for monitoring the cleaning process itself. This should include a systemic test, one that measures the outcome of the cleaning process like a standardized soil test. The inputs to cleaning process should also be monitored and checked by utilizing available devices and instituting preventive maintenance practices. Taking these steps will help to insure that instruments are consistently cleaned prior to sterilization. 18 October 18, 2006

19 Assessing the Cleaning Process by Ralph Basile & Stephen Kovach (appeared in Managing Infection Control 2003) This is an epilogue to a series of articles that have discussed critical aspects of the cleaning process. This final article is meant as an overview and a guide to help you, the Sterile Processing Professional, better evaluate and manage this critical process at your institution. We know that Sterile Processing personnel are highly accountable for all acts relating to the sterilization process. Sterile Processing Departments must maintain a quality assurance program that will measure not only the proper application of sterilization procedures, but will also monitor the efficacy of the sterilization equipment. As Sterile Processing Professionals, we all recognize that cleaning is the first step in the sterilization process. We should then apply the same rigorous methodology we employ to monitor the sterilization process to monitoring the cleaning process. To invoke the axiom: If it is not clean it is not sterile. Driving to Quality Anyone who owns an automobile appreciates the need to have his or her car regularly serviced to be sure it is in proper working order. When an automobile is brand new, if the dealership has done the job right, the car is in perfect working order. Over time, as the car is driven, the mechanics of the vehicle move out of calibration. Similarly, the machinery of cleaning, washers, ultrasonics, etc., also moves out ofcalibration as it is used. Monitoring devices are important tools to catching a machine early on as it moves out of calibration. Of course, this is a significant shift in how things are done. However, it needs to take place. Each of us, as a Professional in this industry has the opportunity to help affect this change. Steps to Take How should you proceed? First, flow-chart your decontamination process. This way you will be sure to capture all the critical stages in the cleaning process. Second, break down each step and identify how you can monitor each of the cleaning process steps. Below is an example of a checklist for monitoring critical steps in the cleaning process. By establishing a program for monitoring the cleaning process, you can Washer-Disinfector Measure Hardness level for both hot and cold water sources Target Temperature for the Cold Water rinse stage Target Temperature for the Enzyme Rinse stage (if appropriate) Target Temperature for Wash Target Temperature for Thermal Rinse Results of Standardized Soil Test Results of Visual Inspection of Instruments Observation of Machine Operation/Condition: Occlusion of Spray Arms Nozzle Direction Freedom of Movement of Spinner Arm Instrument Rack Coupler Staining, scaling of inside chamber Ultrasonic Cleaner Measure Hardness level for both hot and cold water sources Target Temperature for the Enzyme cleaner Target Temperature for Detergent Results of Cavitation Detection Test Results of Visual Inspection of Instruments Observations of Machine Operation/Condition Manual Soak Measure Hardness level for both hot and cold water sources Target Temperature for the Enzyme cleaner Results of Visual Inspection of Instruments 19

20 Assess Cleaning, Continued use this as part of your JCAHO process improvement project. You can show how you monitor each step and how you have improved it. Our suggestion is using the Focus PDA method (Plan, Do, Check, and Act). Below is an example of a 6-step process for a weekly monitoring program utilizing commercially available products: Make History Recall the history of monitoring and testing sterilization. The monitoring devices we rely upon today were not always widely used. The Bowie Dick test is a great example. It did not start out as an industry standard but as Sterile Processing Professionals understood how important air leakage was, our predecessors insisted upon utilizing the Bowie Dick test and pushed for its acceptance as an industry-wide practice. The same was true of the Biological Indicator. The adoption of new methods for monitoring the cleaning process has to start with the end user. Sterile Processing Professionals do not need to wait for a regulatory standard to take the correct action. Remember, Quality doesn t cost, it pays. You might have to do a little more work to make sure your process of cleaning is really getting things clean, but in the long run it will be worth it. So you need to ask yourself, am I going to sit on the sideline and wait for a standard, or am I going to be proactive and understand my cleaning process better and thus make it better not only for my staff but the patient as well? Isn t that what it is all about, improving patient care? Good Luck and Remember Always Keep it Clean. The Steps to Monitor the Cleaning Process 1 AquaChek TM Follow these directions first for Cold Water, then Hot Water: 1. Dip entire strip into water for 1 second (or pass under water stream), remove. Do not shake excess water from the test strip. Reorder# WTS Compare to TOTAL HARDNESS, TOTAL ALKALINITY and PH pads on the interpretation guide. 3. Report any deviations in values from the expected values listed. Record results in log book. 4 LumCheck TM 1. Unscrew and open the LumCheck TM device. Detach part A from part B. 2. Insert the test object part C into part B. 3. Screw part A to part B of the LumCheck TM device close. 4. Connect the LumCheck TM device to the rinse test soil system of the washer and process the same C as cannulated instruments. 5. Load the lumen washer/disinfector normally. A 6. Process as per normal procedure. 7. After the cleaning process is completed disconnect slot the LumCheck TM and examine for visual cleanliness. 8. Record results. Reorder# WLC-101 B 2 TempaChek TM Use one (1) Tempa- Chek TM -90 per washer. 2. Peel thermometer from release paper. 3. Apply to any clean, surface ensuring that the indicator has adhered to the surface. (i.e., place on a used ProFormnace). A good surface to use for the TempaChek TM is a used ProFormance TM Test Reorder# Temp TempaChek TM -90 should be removed and read immediately after the Cold Water Rinse stage. 5. Record results in log book. Temperature should not exceed 100 o F. Immediately report any result that exceeds this temperature. 5 SonoCheck TM Reorder# TI-108 This test is performed to monitor effective generation of cavitation. Parameters such as: water level, de-gassing, instrument load and energy supplied by the transducers can cause variations in the process that effect performance. x x 1. Place a single SonoChek in the Ultrasonic Cleaner without instruments. 2. Run Ultrasonic through a normal cycle. 3. Record results. 4. In larger Ultrasonics, move the placement week to week x x x within the ultrasonic. See illustrations to the right for placement before after locations. SonoChecks. x 3 TempaChek TM Use one Tempa-Chek TM on each level of the Instrument Rack. 2. Peel thermometer from release paper. 3. Apply to any clean, surface ensuring that the indicator has adhered to the surface. Place Tempa-Chek TM -170 on each level of the Instrument Rack Reorder# Temp TempaChek TM -170 should be removed and read after the Thermal Disinfection stage and before the Drying stage. 5. Record results in log book. Report any deviation from targeted temperature on interpretation guide. 6 ProFormance TM 1. Secure one(1) ProFormance per level of the instrument rack in the center of an empty tray (position A in the diagram to right). 2. Process using the instrument wash cycle. 3. If using with TempaChek TM -170, you may remove test prior to the Drying Cycle. 4.Compare the test to the Interpretation Guide. 5. Record results. 6. If less than optimal results were obtained (1-5) make adjustments to the equipment utilizing the Interpretation Guide. A A A 20 October 18, 2006

21 Measuring Clean in Central Service by Ralph Basile, Kurt Browne & Stephen Kovach (appeared in Managing Infection Control 2003) Expert after expert has stated that the key to an effective sterilization process is cleaning. As the saying goes, If it is not clean, it is not sterile. Until recently there has been only one method for monitoring the cleaning process in Central Service Departments, the so-called visually clean standard. While it will always be important for C.S. staff to be vigilant in observing the condition of instruments which have gone Quoting the Experts One of the dilemmas of attempting to define clean is that direct observation will reveal visible soil, but microorganisms are more difficult to detect, inactivate and remove. 1 Over recent years, there have been growing concerns about the effectiveness of decontamination techniques for reusable medical instrumentation in health care facilities. One concern is that inadequately cleaned items may pose an insurmountable challenge to sterilization processes. Another concern is the safety of health care workers handling products potentially contaminated with blood borne pathogens. A third is the presence of chemical residue on reprocessed items form exposure to enzymatic solutions and detergents. 2 Inadequate cleaning of medical or dental instruments can threaten the sterilization process, said Janet Prust, technical service supervisor, 3M Healthcares. 3 Germany s Cleaning Technology Research states, Visual inspection, not the best method, can only be conducted on the outside of instruments, but is not possible to check highly complex or lumen instruments. 4 through the decontamination process, the reality of modern healthcare is that the pressure for throughput and turnaround time may lead to a compromise in vigilance. How can a hospital s Central Service Department enhance the visibly clean practice with an objective, measurable test? The answer might be to look at what industry and the makers of the washers and disinfectors do. Companies that make automatic washers and disinfectors are required by the FDA to prove that their equipment can clean instruments. They must have a qualitycontrol system in place. The manufacturers themselves must validate the efficacy of the cleaning. They must show that their automatic equipment can clean. Manufacturers of automatic cleaning equipment employ a quality process (system) that allows them to monitor the cleaning process. The Veteran s Administration Medical Center (VAMC) in Ann Arbor, Michigan, used such a system as a blueprint for measuring the efficacy of its Central Service Department. The key element of the VAMC quality-control system is the TOSI (Test Object Surgical Instrument), which was first introduced at the World Central Service Symposium Conference in 1999 at Orlando, Florida. Use of the TOSI and other monitoring devices has advanced the VAMC central service staff s understanding of the cleaning process as it relates to their practice. VAMC Case Study In 2002 the SPD Department at the VAMC in Ann Arbor began using a blood soil test to monitor the cleaning performance of its five automated instrument washers. This facility was one of the first in the United States to employ this monitoring device to monitor and improve its cleaning process. Kurt Browne, SPD Chief at the VAMC, recounts the initial experience using the blood soil test. His account illustrates the value of a weekly program to monitor the key parameters of the cleaning process: When the blood soil test device was first being introduced to the American market, our SPD at the Department of Veteran s Affairs in Ann Arbor was among the first to try the device. We like to think of our department as an efficient department that operates with the goal of maintaining our focus on the patient while 21

22 Measuring Clean, Continued performing all of our various responsibilities. We biologically test all of our autoclave and sterilizer loads but had been frustrated at the lack of a consistent method for testing our five washer-decontaminators other than mere visual inspection. As a department, we had been very proud of our department and expected that the blood soil test would simply support our observations that our washing process was completely effective. What we discovered was not at all what we had expected. Our initial test, although not bad, showed a residual amount of fibrin left on the blood soil test strip. Even worse, during our enzyme only cycle, we also had a small amount of blood left visible on the strip. Both of these results were repeated with additional testing. Our first reaction was to increase the cycle time by 100 percent. When this still wasn t effective, we increased the cycle time by another 50 percent. This action, of course, delayed our turnaround time, but we were determined to assure that instrumentation was clean and properly prepared for sterilization. Unfortunately, even after such extreme increases in time, the washer tests were still giving us a positive result. We then considered the possibility that the test itself might be too rigorous and not a fair indicator. We took a sample test, removed the cover which creates a box lock type of simulation, and put the soiled metal plate under tap water flowing from a faucet. With a little quick friction from a gloved hand, we were able to instantly clean the plate. This little experiment demonstrated there was not much difference from the effort required in hand-washing soiled instrumentation. After realizing that the blood soil test was not an unusually difficult challenge, we then contacted the washer manufacturer and told them of our concerns. The manufacturer was familiar with the blood soil test and asked if we could mail them some of the tests from the same lot number. After receiving these, they tested them on units that they had available at their facility. They found that their results were negative, and they sent us photocopies to verify their findings; however, they were concerned that we had dramatically added time to our wash cycles and wanted to help us solve our problem. The washer manufacturer questioned the temperature of our detergent storage and sent up a temperature recorder that we placed on our detergent jugs for a period of two weeks. After reviewing the data gathered, the president of the washer company came out to our facility to address the problem personally. He spent about a day adjusting the cycles on our washers and discovered that they needed a temperature adjustment during the initial phase of the wash cycle. He learned that the initial wash was so hot that it was baking on the fibrin and blood. Lowering the initial temperature of the wash cycle, and then raising it during the cycle effectively removed the fibrin and blood. As a result of this experience, we have established a protocol of rou- 22 October 18, 2006

23 Measuring Clean, Continued tine testing of all of our washers. We log all of the tests, the specific washers tested, the racks used for testing, and, of course, the results. We have established a procedure that is quite similar to our recording of sterilizer test loads. This includes additional testing after all major repairs. This data is kept on file as documentation of the efficient functioning of our washing process. The underlying premise for this weekly monitoring protocol is that a standardized testing of the cleaning efficacy of an automated washer in a routine manner will help insure the delivery of clean, disinfected and sterile instruments to the patient care site. A time interval of one week is a compromise between monitoring the cleaning process in real time and the financial realities of utilizing a test methodology that involves new expenditure. Weekly monitoring at Date: this time is frequent enough to alert staff that a washer is moving out of calibration without allowing days or even weeks to go by. The Ann Arbor VAMC s experience indicates that factors or inputs other than a blood soil test need to be monitored during the automatic washing cycle. The VAMC s consistent and dedicated use of the blood soil test ideally qualified it as a facility to trial a new quality protocol for monitoring the automatic washing process. Quality Process for Monitoring Clean After using the blood soil test, the VAMC SPD staff realized that the cleaning process involves many variables that directly affect the outcome of the test. Additional information is required to explain the blood soil test ProFormance TM Washer Monitoring Weekly Log Sheet: 3 Level Rack (AWTK-3L) Facility: Washer: Rack No: Name: results and to make a diagnosis. All parties realized that certain basic steps were needed to ensure quality monitoring of the cleaning process. The FDA Quality System guidelines were reviewed and adapted for the VA s cleaning process. The requirements for good cleaning practice are as follows: An effective management control system is in place covering all aspects of the cleaning /decontamination cycle. Appropriate facilities are provided. Appropriate equipment is utilized, which is: - Fit for purpose; - Properly maintained and calibrated; - Properly monitored and validated. Standardized repeatable test Water Quality Aquachek (circle result) Pre-Wash Temperature TempaChek-90 Target Values p: A: H: Temperature Should Not Exceed 100 o F Record Result (darken temperatures reached) Cold Water ph Level: Alkalinity: Hardness: Circle Result Pass Fail Comments Hot Water ph Level: Alkalinity: Hardness: Comments Comments Staff are properly trained and supervised. Single-use medical devices are not reused. Records of cleaning /decontamination are kept. Verification of Record Result Cleaning (circle result) Efficacy Proformance Thermal Disinfection TempaChek-170 Target Temp: Record Result (circle highest temp achieved) Bottom Middle Top Comments Comments The VAMC was already fulfilling most of these requirements. The area requiring improvement was the monitoring, calibration, and validation of the cleaning process. Key elements to be monitored were the standardized blood soil test, the cold-water rinse cycle, thermal disinfection tempera- Copyright Healthmark 00 1 AWTK-3L/10/03 23

24 Measuring Clean, Continued ture, and water quality all factors that have a direct affect on the cleaning process. Staff would observe and inspect equipment, and would be trained in its proper use and loading. Records of all results would be kept in a standardized log. Blood Soil Test The blood soil test used at the VAMC is made up of three key components: a test soil, a stainless steel plate and a clear plastic holder. The test soil is chemically engineered to mimic the hemoglobin and fibrin components of human blood. The stainless steel plate is scratched or grooved, replicating the uneven surface of surgical instruments. The plate is mounted in the plastic holder at an angle, providing a gradually more difficult cleaning test from one end to the other. The clear holder allows visual inspection of areas not usually seen (e.g., box locks). A key aspect of a test like this is that it is standardized. Each test represents an identical challenge to the cleaning efficacy of the washer. Cold Water Rinse An irreversible thermometer was used to record the temperature of the cold-water rinse cycle only. The key issue is that at temperatures above 45 o C (113 o F) blood denatures, or cooks on to the surface of instruments. The blood becomes highly insolvent and is very difficult to clean. The methodology is to place one test somewhere in the machine (e.g., on the side of the instrument rack) and run the washer through the cold rinse cycle. At the end of this cycle, the machine is stopped, the thermometer removed and the results recorded on the Log Sheet. Thermal Disinfection Temperature A second irreversible thermometer was used to record the temperature for thermal disinfection. This temperature varies among makes and models of washers on the market today. The washer in use at the Ann Arbor VA required a temperature of 194 o F (90 o C). It is important to note that typically a washer s temperature indicator will report the temperature of the water being injected into the machine, referred to as the manifold temperature. Manifold temperature is not as important as the temperature reached on the surface of the instruments. Instruments themselves need to reach the target temperature for disinfection to occur. The methodology for this test is to place one irreversible thermometer on each level of the instrument rack, run the washer through the thermal rinse cycle, and then stop the machine. The tests are then removed and the results recorded on the Log Sheet. Water Quality The importance of water quality (hardness, ph level, alkalinity) is well documented. Poor water quality adversely affects a washer s ability to clean instruments. Water hardness has a significant impact on the effectiveness of detergents, and ph level is critical to the effectiveness of enzyme cleaners. A good monitoring program includes testing these levels periodically to ensure that neither has changed. Water alkalinity is a secondary statistic, but is a predictor of volatility in the ph level of water. The methodology is to test the water quality weekly at a tap near the washers. Both cold and hot water are tested. Equipment Inspection Daily and weekly inspection of the cleaning equipment is as important as the testing itself. Steps for inspection usually are found in the automated equipment manual and range from examining the spray arms to cleaning the screens. Misaligned spray arms and clogged spray nozzles are only two potential problems that can be identified with daily observations. If the washer s spray arms are not working properly there will not be sufficient action to remove the protein from the instruments. Equipment inspection is a vital part of a 24 October 18, 2006

25 Measuring Clean, Continued Is that Blood or Something Else? quality system to monitor the cleaning process. Results of Monitoring The Ann Arbor VAMC SPD staff followed the methodology described above to monitor the cleaning efficacy of a single washer (washer #3) for four consecutive weeks. The complete log sheet (page 23) reports these results. During the four-week period, washer #3 remained in perfect working order and required no adjustments. This is excellent news for patients, as it documents that a Quality Improvement Process is in place to deliver thoroughly cleaned instruments for patient care. Jim Knipfer, Decontamination Leader at the VAMC, said, If the TOSI doesn t come clean, I call the company. I know something is wrong with my equipment, and with the other information I can help them fix my concern quicker. The reasons for the Ann Arbor VAMC s success are clear. The SPD needed to enhance the visually clean standard to verify that its cleaning process was effective. In order to achieve this, the SPD staff had to acquire an understanding of the complete cleaning process and the many variables involved. They realized that staff training and education are paramount. When staff understands that the cleaning process has many variables, they can test these variables and produce a result that is a useful assist to relying upon visual observation only. The tests provide SPD staff with confidence that their process is complete. If the institution s standard for clean is not achieved, staff must determine the reason for the failure and make the necessary adjustments. Implementing a quality-monitoring program for the SPD is not difficult, but does require some time time well spent to insure that customers (patients) are provided with quality healthcare and clean instruments. For the first time, there is an independent, standardized and objective method for of verifying the cleaning process. Verification assures the public and healthcare workers that the institution s standard is met, maintained, and monitored in a quality way. A quality monitoring system will allow a Central Service department to objectively verify the efficacy of the cleaning process. No longer will staff rely solely on the subjective observation of clean. 25 (patent pending) Know for Sure with HemoCheck TM Finding a stain on an instrument which has gone through reprocessing is never good. If the stain is blood, the implications are even more serious. Take the guess work out of evaluating the cleanliness of instruments with the HemoCheck TM blood residue test kit. The HemoCheck TM is an all-in-one test, provides a result in 30 seconds, is simple to interpret and indicates blood residue down to 0.1µg. Significant traces of blood indicate an inadequately reprocessed instrument and is a rich source for cross contamination. To use the HemoCheck TM, simply swipe the surface of the instrument, drop the swab in the activated indicator, shake vigorously, wait for 30 seconds and check for color change. If the swab remains yellow, the instrument is free of blood. If any area of the swab turns green or blue, the surface harbors blood residue and should be reprocessed. If many instruments are found to be soiled, a thorough evaluation of the decontamination processes should be conducted. The ProFormance TM line of products can be used to do just that. Blue or Green indicates blood healthmark INDUSTRY COMPANY healthcare products

26 Competency for Weekly Testing of the Automatic Washer Process Keep all information in employee educational file. Understanding the Cleaning Process. Cleaning, not sterilization (or disinfection) is the first and most important step in any instrument processing protocol. Without first subjecting the instrument to a thorough, validated and standardized (and ideally automated) cleaning process, the likelihood that any disinfection or sterilization process will be effective is significantly reduced. Washers fail to clean for many reasons. Tests should provide a means of monitoring the variables that influence the effectiveness of a washer. Some of these variables are water quality, time, detergent, enzyme, temperature, ph level, agitation, speed, initial temperature, drying time, obstructions, and insufficient amount of chemicals. Proper cleaning is critical. The T.O.S.I. blood soil along with the test kit (temperature and water quality monitoring) provides an independent objective test of clean and allows the Sterile Processing professional to monitor and ensure proper cleaning in the automated instrument washer/ disinfector process. What is a washer/disinfector and what does it do? Cleaning is the removal of all visible dust, soil, any other foreign material and some microorganisms. A washer/disinfector cleans and decontaminates dirty surgical instruments so they can be handled safely, repackaged, and sterilized for a future surgery. The danger of handling instruments contaminated with blood is obvious in this age of hepatitis, CJD and HIV. The procedures for sterilizing instruments are based on years of scientific testing of clean instruments. If surgical instruments are not clean, the procedures are ineffective. Dried blood on instruments is hazardous to the employees of the hospital and to the next surgical patient upon which the instruments are used. The cleaning of dried blood is much more difficult than cleaning dirt. Blood coagulates, which means it goes from a free flowing liquid to a solid that contains tough, microscopic fibers called fibrin. These fibers are formed as the blood coagulates and jam themselves into microscopic irregularities in the surface of the stainless steel instrument. This is a physical attachment to the surface through mechanical means, not just chemical means as with traditional adhesives. The action is similar to the roots of plants growing into cracks in rocks, anchoring themselves to the surface. The blood cells colored with hemoglobin are fairly easy to wash off instruments but the clear fibrin material is much more difficult. Thick droplets of dried blood have so much fibrin; even the colored hemoglobin can be trapped and held in place. Another thing that makes blood difficult to clean is its ability to become insoluble when heated. Heating causes blood to denature. Denaturing is similar to eggs cooking in a frying pan. Transparent uncooked egg whites are fairly easy to wash away, but opaque, cooked egg whites are much more difficult. Dried, uncooked egg is even more difficult to wash away, just like blood. The proteins in blood are similar to albumin proteins in eggs. Having the correct temperature is very important in the automatic washer. If the temperature is set too high during the pre-wash stage, blood will denature at 45 o C (113 o F). When blood denatures, it become highly insolvent. It bonds strongly to the substrate (e.g., the surface of instruments) and it dries out becoming very resistant to the action of solvents. What helps the cleaning of blood from instruments? Water: Water will moisten dried blood and make it possible to wash away. Avoid dried blood by cleaning as soon as possible or keep instruments moist while waiting. The relevant measurable characteristics are temperature, ph level, hardness, alkalinity, and purity (microbial contamination). Water hardness plays an important role in how much detergent / enzyme is necessary. Water Hardness: Is defined as the concentration of calcium and magne- 26 October 18, 2006

27 Competency, Continued sium ions expressed in terms of calcium carbonate. These and other minerals bind with the cleaning agents in detergents and prevent them from reacting with the soil on instruments. The amount of hardness minerals and other dissolved solids in water present obstacles to good cleaning. Hardness minerals can cause spotting and filming on instruments. They must be effectively tied up or sequestered if the cleaning results are to be satisfactory. The harder the water the more concentrated the solution will be. Time: With enough time, simple water will remove all types of blood. Detergent: The wetting ability of detergent will help water flow to all places in and around the blood, even if water-repellent fats and oils are used. Enzyme: Enzyme cleaners break down long fibrin fibers, allowing water to wash away the pieces but time is needed for this action to take place. The time needed to act depends on many factors from concentration, hardness, ph, along with the type and amount of soil to be removed. Temperature: Low temperature to start (to prevent denaturiing) and higher temperature later to maximize detergent cleaning efficiency. Make sure you have chosen the correct temperature for the correct cycle setting. ph: The ph scale goes from 0 to 14. The halfway point is 7(neutral); there is a balance between acidity and alkalinity. Such a solution is neutral (7). 0 to 6 on the scale is called an acid. 8 to 14 on the scale is called alkaline or a base High ph: Moist alkaline conditions dissolve dry proteins and cause fibrin to break, similar to enzyme action. Agitation: Physical agitation from water spray brings fresh cleaning solution to the soiled area and washes away used-up detergent. Spray impulses loosen blood through physical impact. Spray from different angles helps prevent blocking from instruments piled atop one another. Remember do not stack or over load instruments in any tray. Evenly spread instruments within the tray to provided optimum exposure to the cleaning solution and spray arm action. Total alkalinity: Is the total concentration of bases in water expressed as parts per million (ppm) of calcium carbonate (CaCO3). Total alkalinity is a measure of the buffering capability of water to resist changes in the ph level. It is desirable at every given level of ph, to have a high level of alkalinity. Alkalinity then is the ability to neutralize acids. What hinders the cleaning of blood from instruments? Speed: Hospitals that must turn instruments around quickly cannot rely on simple water to do the job. Water must be made more powerful through chemical assistance, enzyme, detergent, high ph, temperature and physical assistance through spray agitation. Each of these elements need time to work. Initial Heat: The denaturing action of heat on blood makes it insoluble enough to interfere with rapid cleaning. Start with a cool rinse. Drying: Dried blood and proteins are much more difficult to clean than moist blood. Clean instruments as soon as possible after surgery or keep moist, if possible, while waiting. Glutaraldehyde: Glutaraldehyde denatures proteins, making them more insoluble. O b s t r u c t i o n s : Closed hinges on instruments are much more difficult to clean. Overloading causes blockage of spray agitation. High mineral content of water causes spray arms to become blocked. Tall items can prevent rotation of spray arms. Insufficient Amount of Chemicals: Detergents may be weak or en- 27

28 Competency, Continued zymes may be ineffective. Blocked or kinked dispenser tubing may be limiting the amount of chemicals being pumped into the washer/disinfector. Broken pumps, incorrect temperature, coupling systems and spinner arm concerns all play a role in providing properly chemical activity. Also know how your chemicals are stored because temperature can inactivate them if stored improperly. Why Monitor the process? Washers fail to clean for many reasons. Testing provides a means of monitoring the variables that influence the effectiveness of a washer. Some of these variables are water quality, time, detergent, enzyme, temperature, ph level, agitation, speed, initial temperature, drying time, obstructions, and insufficient amount of chemicals. JCAHO and AAMI both recommend that Sterile Processing departments have Quality Improvement Process in place. JCAHO in standard E.C Medical equipment is maintained, tested and inspected. AAMI ST 36 / Verification of the cleaning process:. A quality system would call for the decontamination processing parameters to be monitored and documented. Using the T.O.S.I. blood soil test according to the manufacturer s guidelines helps ensure adherence to both JCAHO and AAMI standards and thus a properly functioning cleaning process. The frequency of monitoring the cleaning process will follow the established hospital policy. Quick Review - Remember the word W.A.T.E.R. Water- quality of the water being used has a direct effect on the outcome; ph, hardness, taps, distilled or de-ionized. Thus the reaction of the cleaning agent depends on good water quality and directly impacts the concentration and the time (exposure time) the cleaner has to work. More is not always better. Agitation - helps to suspend soils so detergents can remove them, friction. Temperature - increasing or decreasing the temperature changes the rate of chemical reaction Equipment & Employee - always follow manufacturers instruction, understand how your equipment and supplies work and train your staff in understanding why they are doing each task. Regulations - guidelines by AAMI and JCAHO both support the monitoring of the cleaning process. Questions True or False: Circle the best answer 1. The blood cells colored with hemoglobin are fairly easy to wash off instruments but the clear fibrin material is much more difficult. True or False 2. Moist alkaline detergents dissolve dry proteins and cause fibrin to break, similar to enzyme action. True or False 3. In general the harder the water the more detergent/ enzyme solution will be used in the cleaning process. True or False 4. A solution with a number of 10 would be called an base solution. True or False 5. A Quality Improvement Process is supported by both AAMI and JCAHO for monitoring the cleaning process. True or False 6. Cleaning is the removal of all visible dust, soil, any other foreign material and some microorganisms. True or False 7. A solution with a number of 9 on the ph scale is called an acid solution. True or False 8. Following the manufacturers instructions is not important in the cleaning process? True or False 28 October 18, 2006

29 Competency, Continued 9. In the Pre-wash cycle the temperature should be colder (under 113 o C) rather than hotter (greater than 113 o C). True or False Go beyond what you can see and test the cleanliness of instruments with the HemoCheck TM Blood Detection Kit and Surfaces with the ProChek TM protein detection device. It is invisible to the human eye, but with the SonoCheck TM you can test for the presence of cavitation energy - the cleaning power - of your Ultrasonic Cleaner. 10. Staff should have at least yearly training on the operation of the automatic washing equipment this is important in making sure instruments are getting clean. True or False Answers 1. True 2. True 3. True 4. True 5. True 6. True 7. False 8. False 9. True 10. True Reveal the hidden areas of instruments (like box locks) with the TOSI TM automated washer test, the easy to use blood soil device that mimics the cleaning challenge of surgical instruments. healthmark INDUSTRY COMPANY healthcare products

30 SUGGESTED POLICY FOR MONITORING THE CLEANING EFFICIENCY OF AN AUTOMATED INSTRUMENT WASHER/DISINFECTOR PROCESS USING THE T.O.S.I. Blood Soil Test (Weekly Testing / Daily Inpsection) SUBJECT: Automated Instrument Washer/Disinfector Cleaning Monitoring DEPARTMENT: Central Service APPROVED BY: EFFECTIVE: REVISED: 06/15/05 PURPOSE: To monitor the automated instrument washer/disinfector process to ensure proper cleaning and reduce risk to personnel or patients. (1,2,19,21,22) POLICY The T.O.S.I. blood soil test is designed to monitor the cleaning function of an automated instrument washer. To ensure that the automated instrument washer process is cleaning properly, a T.O.S.I. blood soil test should be used to monitor the occurrence of cleaning. The T.O.S.I. blood soil test is to be used according to the manufacturer s guidelines to ensure that the cleaning process is occurring and the automated instrument washer is functioning properly. (1,2,3,4,15,16,17,18,19, 21,22) RATIONALE Cleaning, not sterilization (or disinfection), is the first and most important step in any instrument processing protocol. Without first subjecting the instrument to a thorough, validated and standardized (and ideally automated) cleaning process, the likelihood that any disinfection or sterilization process will be effective is significantly reduced. (20) An automated washer/disinfector cleans and decontaminates dirty surgical instruments so they can be handled safely, repackaged, and sterilized for a future surgery. The danger of handling instruments contaminated with blood is obvious in this age of hepatitis, CJD and HIV. The procedures for sterilizing instruments are based on years of scientific testing of cleaning instruments. If surgical instruments are not clean, the procedures are ineffective. Dried blood on instruments is hazardous to the employees of the hospital and to the next surgical patient upon which the instruments are used. (5,6,7,17,21,22) Cleaning dried blood is much more difficult than cleaning dirt. Blood coagulates, which means it goes from a free-flowing liquid to a solid that contains tough, microscopic fibers called fibrin. These fibers form as the blood coagulates and jam themselves into microscopic irregularities in the surface of the stainless steel instrument. This is a physical attachment to the surface through mechanical means, not chemical means as with traditional adhesives. The action is similar to the roots of plants growing into cracks in rocks, anchoring themselves to the surface. The blood cells colored with hemoglobin are fairly easy to wash off instruments, but the clear fibrin material is much more difficult to remove. Thick droplets of dried blood have so much fibrin, even the colored hemoglobin can be trapped and held in place. (5,6) Another factor that makes blood difficult to clean is its ability to become insoluble when heated. Heating causes blood to denature. Denaturing is similar to what happens to eggs cooked in a frying pan. Transparent uncooked egg whites are fairly easy to wash away, but opaque, cooked egg whites are much more difficult. Dried, uncooked egg is even more difficult to wash away, as is dried blood. The proteins in blood are similar to albumin proteins in eggs. Washers fail to clean for many rea- 30 October 18, 2006

31 SUGGESTED POLICY, Continued sons. Tests should provide a means of monitoring the variables that influence the effectiveness of a washer. Some of these variables are water quality, time, detergent, enzyme, temperature, ph level, agitation, speed, initial temperature, drying time, obstructions, and insufficient amount of chemicals. (16) Proper cleaning is critical. The T.O.S.I. blood soil provides an independent objective test of clean and allows the Sterile Processing professional to monitor and ensure proper cleaning in the automated instrument washer/disinfector process. (21,22) JCAHO and AAMI both recommend that Sterile Processing departments have process performance in place (1,2,3,8,9,10,11,21,22). Using the T.O.S.I. blood soil test according to the manufacturer s guidelines helps ensure adherence to both JCA- HO and AAMI standards and thus a properly functioning cleaning process. PROCEDURE: A problem analysis should be completed for any problem with any aspect of decontamination that can pose a risk to personnel or patients. The problem analysis should define and resolve the problem and the system should be monitored to ensure that the problem has been corrected. (21) Begin with performing an equipment inspection as specified on the log sheet. Start with the spray nozzles/arms and proceed with all items listed on the work sheet. After observations and equipment check are completed, proceed with the first test and record all results. Daily Inspection & Testing Follow manufacturer guidelines concerning the daily inspection of equipment (spray arms, screens ) Inspect the level of the detergent daily (mark the container of the solution daily with the date at the level of the solution in the container) this will allow a visual inspection if the solution is actually being used. Bring to the attention any concerns on the equipment that the inspection revealed to the proper person in the department to address. Weekly Inspection and Testing Do a complete test of all of the inputs of the automatic washer (temperature, ph, hardness, etc.) Equipment Inspection Inspect all washer equipment (spray arms, screens, etc.) according to the log sheet. Water Quality Follow these steps first for cold water, then hot water: Use an Aqua Test (WTS-101) test strip. Dip entire strip into water for 5 seconds, then remove. Shake once briskly to remove excess water from the test strip. Wait 20 seconds. Compare color within 10 seconds to ph, Total Alkalinity, Total hardness on the interpretation chart. Report any deviations from expected values. Note that water conditions do change seasonally. It is important to establish a base line (target values) for your water and to compare your results to that base line/value. Pre Rinse Water Temperature Use a TempaChek-90 for this test. Use one (1) Tempachek-90 per washer. Peel thermometer from release paper. 31

32 SUGGESTED POLICY, Continued Apply to any clean, dry surface, ensuring that the indicator has adhered to the surface (i.e., apply to the smooth surface on the T.O.S.I. rack). Tempachek-90 should be removed and read immediately after the COLD WATER RINSE stage. If the machine has a window, the result can be read through the window; if not, the cycle must be stopped. Belimed, Getinge and Hamo machines cannot be stopped; results must be read through the window. Record results on log sheet. T e m p e r a t u r e should not exceed 110 degrees F. Immediately report any result that exceeds this temperature. Thermal Disinfection stage Use one Tempachek-170 on each level of the instrument rack. Peel thermometer from release paper. Apply to any clean, dry surface, ensuring that the indicator has adhered to the surface (i.e., apply to the smooth surface on the T.O.S.I. rack). Tempachek-170 should be removed and read after the THER- MAL DISINFECTION STAGE and before the drying stage. Record results on log sheet. Report any deviation from targeted temperature. TESTING IS COMPLETED AFTER THIS CYCLE COM- PLETES o Abort cycle if possible Blood Soil Test A batch-type washer (Belimed / Steris 444 / Getinge 8666A) uses one rack with multiple levels. Each level should be tested at the same time. If the rack has two levels, then two tests are used; if the rack has three levels, three tests are used. One test per level on each rack is the standard. Once a week on a designated day, secure one T.O.S.I. in the center of an empty tray in each washer/disinfector. Do this as many times as you have shelves. If multiple shelves are present, place a tray with a T.O.S.I. on each shelf. Load a rack with its T.O.S.I in each washer/disinfector to be tested. Secure one T.O.S.I. to a rack and place it in an empty instrument tray. Run in an empty machine. Process using the normal procedure/cycle. It is suggested that each cycle be tested to ensure that it is working properly. If a machine uses three cycles, all three should be tested each week. Examine the T.O.S.I. for visual cleanliness. Compare the test to the 0-5 T.O.S.I. chart scale. Record results. Immediately report any test failure to department management. Use the results found when comparing the test object and to the T.O.S.I. chart to determine what, if any, adjustments need to be made. Make necessary adjustments. The next week, repeat the process. Record all results. Maintenance on Equipment(15,19): After any maintenance on the equipment, perform a test using the T.O.S.I. Washer Test to ensure that the equipment is cleaning properly. 32 October 18, 2006

33 ProFormance TM Washer Monitoring Weekly Log Sheet: 3 Level Rack (AWTK-3L) Date: Facility: Washer: Rack No: Name: SUGGESTED POLICY, Continued Water Quality Aquachek (circle result) Target Values p: A: H: Cold Water ph Level: Alkalinity: Hardness: Comments Hot Water ph Level: Alkalinity: Hardness: Comments Follow the weekly test process. Pre-Wash Temperature TempaChek-90 Temperature Should Not Exceed 100 o F Circle Result Pass Fail Comments Have the maintenance person wait until the test results are complete before leaving. Record Result (darken temperatures reached) Verification of Record Result Cleaning (circle result) Efficacy Proformance Bottom Middle Top Comments 5 RESPONSIBILITY: Thermal Disinfection TempaChek-170 Comments Central Service personnel are responsible for the proper use, result interpretation, and documentation of the T.O.S.I. indicator when used on an automated instrument washer. (1,2,3,4,21,22,12) Staff in-service and training on the equipment and proper T.O.S.I use should be done at least once each year. REFERENCES: 1. ANSI/AAMIST e- Documentation of decontamination processing parameters 2. ANSI/AAMIST General Rationale 3. ANSI/AAMIST Quality process Target Temp: Copyright Healthmark 00 Record Result (circle highest temp achieved) 7. OSAKA REPORT; Importance of the cleaning test; University of Osaka, Department of Medicine, Ryo Fushimi, 2000 Date: Spray nozzles/arms are free of debris Nozzles(holes) properly aligned at target surface (up & down) All spray arms are present Bottom yes no Chamber Top yes no 1 8. JCAHO Hospital Standards -IC.1- The organization uses a coordinated process to reduce the risks of endemic and epidemic nosocomial infections in patients and health care workers. AWTK-3L/10/03 9. JCAHO Hospital Standards - IC The infection control process includes at least one activity aimed at preventing the transmission of epidemiologically significant infections between patients and staff 10. JCAHO Hospital Standards- PE Quality control Racks Bottom Middle Top yes no yes no yes no Comments 4. ANSI/AAMIST Blood as a Soil on Surgical Instruments; Cleaning Profile, Cleaning, Detection; M.Pfeifer, Zentr Steril 1998;6 (6); Standardized Test Soil Blood 1: Composition, Preparation, Application; M.Pfeifer, Zentr Steril 1998;6 (6); Spray arm spin freely Spray arm bushings are intact Debris screen (in bottom of chamber) is clear of debris Instrument rack coupling with manifold properly No staining/scaling from detergent, hardwater, etc. Detergent/enzyme at sufficient level in container Reviewed Cycle Settings (compared to Master) Other observations (comment) Recommended Actions yes no AWTK-3L/10/

34 SUGGESTED POLICY, Continued checks, as defined by the hospitals, are conducted on each procedure. 11. JCAHO Hospital Standards - Pl.5-Improved performance is achieved and sustained 12. JCAHO Hospital Standards - EC.2.1- Staff members have been oriented to and educated about the environment of care, and process the knowledge and skills to perform their responsibilities under the environment of care management plans 14. ANSI/AAMI com/wallchart/wallchart.html JCAHO Hospital Standards com/supportmaterial/technicalbulletin1.html com/supportmaterial/bloodasasoilonsurgicalinstruments.htm com/supportmaterial/standardisedtestsoilblood1.htm com/index.html Does Your Instrument Washer Clean as Well as Your Dishwasher? Take the ProFormance TM Dishwasher Challenge. Take The Challenge to Win! ( k ) Summary and Overview; Safety, Efficacy and Microbiological Considerations,. The System 83 plus Washer -Disinfector; Custom Ultrasonics, Inc,1998, page page 23, Section 9.2 ANSI/ AAMIST p a g e 19,Section ANSI/AAMIST October 18, 2006

35 Validation of TOSI Test Object Surgical Instruments for the Monitoring of the Cleaning Efficiency of Washer-Disinfectors Martin Pfeifer, Waldkraiburg, Federal Republic of Germany Summary Validation as the proof of intended use is of major importance for any test monitors for all type of medical devices. The following describes the validation of the newly introduced TOSI test objects as a useful monitor for the control of the cleaning efficiency relative to blood and blood components in washer-disinfectors. The results show correlation of the TOSI test soil to human blood as well as easy reading and safe interpretation of results through visual inspection of the test objects while compared to a chemical test method. All data proof the achievement of the requested design goals of TOSI. ever the proof of sense of a product only correlates with the defined quality of such product. As an example, fast food products definitely have a defined quality even though people may have a different opinion about such quality. As a general definition validation shall be explained as the proof that a certain process fulfils the requirements for its intended use. As a first step this intended use has to be defined either by general public interest or through legal regulations. In next steps the intended use of such process shall be defined precisely, including all necessary testing procedures, and an answer has to be given in respect to the process capability to meet the requested requirements. In the specific case of the development of a monitor for the detection of the cleaning efficiency in washer-disinfectors the following goals had to be achieved: There is general public interest that CSSD provides surgical instruments which are free from any residuals which may cause harm to patients, personnel or any third party, and there is the European Medical Device Directive and its corresponding regulations of each member state like the German Medical Device Law (MPG) and the German Medical Device Operator Regulations (MPBetreibV). The latter was published in June 1998 and went into effect immediately without any transition period. The regulations require that the function of each washer-disinfector be tested and reconfirmed prior to use. Future regulations, norms and directives will take care about most of the quality requirements of medical devices and monitors. Introduction Literature gives a lot of definitions for the term validation, starting with the proof of principle of a certain method all way down to the documentation of a process, which results in a product with defined and guaranteed quality. There is no doubt about the importance of the proof of principle of a certain technique, how- 35

36 Validation of TOSI Continued Materials and methods 1. General requirements There are a lot of different washerdisinfectors available in the market place. They are equipped with a number of different programmes consisting of rinsing steps with cold water, cleaning steps followed by rinsing again, disinfection, rinsing, instrument care steps and drying. materials and soils other than blood on surgical instruments mechanical detaching Any change of critical cleaning parameters may impact this sensitive interplay resulting in insufficient cleaning. Some examples are changes of cleaning chemistry or its dosage, of cleaning temperature or time, Comparison of cleaning kinetics: Test soil vs. Human blood in demineralised water 20 C The variety of materials to be reprocessed includes different types of surgical instruments, plastic parts and even glassware. Soils may be multivariable as well. Aside from blood and blood components, there are i.e. residuals of ointment or stool may be present. Protein residues in % Human blood TOSI/Test soil It is clear that such variety of cleaning-disinfection programs, materials and soils requires more than the validation of just one process. This is also the case for the validation of a useful monitor for the control of the cleaning efficiency. TOSI (Test Object Surgical Instruments) was designed for the monitoring of the cleaning efficiency when reprocessing blood-contaminated surgical instruments in washer-disinfectors. Blood is by far the most frequent contaminant on surgical instruments and is considered to be of high hygienic relevance. In addition blood coagulation and high concentration of proteins result in complex chemical reactions, which may severely impact the whole reprocessing. Additional test objects and test soils are under development to cover Time in minutes Fig. 1: Comparison of cleaning kinetics: Test soil vs. Human blood in demineralised water The designated intended use of TOSI is the monitoring of the cleaning efficiency relative to blood. Critical parameters for the blood removal during cleaning in a washer-disinfector are mechanical parameters like water pressure, distribution of water or ultrasonic, but also chemical parameters like the ph-value and the water quality as well as the cleaning temperature. This simple job of just rinsing away blood from instruments may be affected by conditions which are specific for blood proteins like: - water solubility of proteins - denaturation effects - hydrolysis or any mechanical disturbances as caused by a blocked spray system. In order to control all relevant parameters TOSI combines the features of a test soil correlated to human blood with a specially designed test object. The blood cleaning efficiency is shown visually immediately after the end of cycle. 2. Suitability Test The first question to be answered concerns the cleaning efficiency of 36 October 18, 2006

37 Validation of TOSI Continued a washing cycle. What causes good, incomplete or inferior results and how are they detected? A known high cleaning efficiency may be reached with alkaline detergents at a high cleaning temperature. Assuming a long enough cleaning cycle time combined with reliable mechanical performance of the machine there should be efficient cleaning of the reprocessed instruments, and TOSI should confirm the result. Insufficient results may be caused by any handling mistake or by an invalid process. Two protocols were used for suitability testing: In one protocol the first rinsing cycle was conducted at a temperature higher than the denaturation temperature of blood proteins, with the result of a partial hardening of proteins which could not be dissolved during the following cleaning cycle. In another protocol an alkaline detergent was used at a too low temperature and was therefore unable to decompose the fibrin fibers. In addition the general detaching capabilities of blood and the TOSI test soil were compared to confirm TOSI s correlation with human blood. Results 1. Correlation with blood Washer-disinfectors are no useful tool for such study, as the spray systems and the resulting distribution of water do not generate homogenous and reproducible cleaning conditions inside the machine. A dipping process in a suitable basin with demineralized water is a much better and more reproducible tool to test the correlation of the TOSI test soil with human blood. Measuring the amount of detached substances online will result in the cleaning kinetics of the test soil and human blood which may than be compared. Fig. 1 shows the correlation between the standardised test soil and human blood in demineralized water at room temperature. This correlation study indicates another important conclusion concerning the composition of blood. It is clearly visible that most of the blood proteins are water soluble, while only relatively little residuals of water insoluble fibrin fibers remain on the test object. But it also says that a 100% cleaning efficiency may not be achieved with water only, therefore the aid of mechanical cleaning parameters is needed. The standardised TOSI test soil simulates this phenomenon. Corresponding fibrin fibers forming coagulation factors are used in the test soil at a level which is somewhat higher than in coagulated human blood to represent worst-case scenario conditions. Chemical evaluation by hydrolysis Protein residues in mg

38 Validation of TOSI Continued Result: All test objects show optimal result with no residuals left. In addition to the visual inspection of the TOSI test objects, the remaining residuals were dissolved in sodium hydroxide and chemically measured in the UV-region of the light spectrum. 2. Reading of Cleaning Efficiency In addition to the dipping protocol for correlation testing, the TOSI test soil was also examined in a special testing washer-disinfector under various test conditions. All test were conducted in 6 replicates with 3 test objects per run. Test A: Mistake in initial rinsing protocol caused by too high temperature resulting in denaturation of blood proteins. This trial was simulated by cleaning in demineralised water at 65 C for 10 minutes. Result: The test soil remained more or less completely on the test object. Test B: Cleaning with low efficiency caused by mistake in temperature selection. This trial was simulated in a cleaning program with 0.5% alkaline detergent in demineralized water at 30 C for 10 minutes. Result: Fibrin residuals are easily detectable. Test C: Efficient cleaning with protein hydrolysis. This trial was simulated in a cleaning program with 0.5% alkaline detergent in demineralised water at 80 C for 10 minutes. Fig. 2 shows the amount of proteins measured with the chemical sodium hydroxide hydrolysis before and after each trial. The graphic shows the average of each of the 18 tests obtained in each trial. Fig. 3 shows photographs of the results of the optical evaluation of the test results. Note: In order to allow for best picture quality the plastic clips of the test objects were removed. For visual inspection a schedule of 6 (from 0 to 5) is recommended, where 0 stands for an optically clean result while 5 stands for test soil still completely visible. Table 1 shows the results of the Tests A, B and C and their classification according to schedule 0-5. Important note: Within tests all 18 test objects showed the same reading. 38 October 18, 2006

39 Validation of TOSI Continued A comparison of the chemical evaluation with the simple visual inspection shows very good correlation. Therefore visual inspection of test objects is considered to be a valuable detection system, mainly knowing that protein residuals may be visually detected at low mg-levels already. The more complicated chemical determination has the disadvantage that smaller amount of proteins like shown in trial B may interfere with high background measures caused by residuals of the cleaning detergent. Discussion The TOSI test soils correlates with human blood and is therefore a safe monitor to control the complex cleaning process of blood contaminated surgical instruments. Handling mistakes or parametric conditions causing insufficient cleaning of blood contaminations are detected safely. TOSI is not intended to be a monitor to detect mistakes which may happen during disinfection, instrument care and drying. Generally TOSI is intended to monitor the cleaning efficiency of the total process, therefore mistakes may add up or a very strong process parameter may balance a weaker process parameter. At current TOSI test objects are intended for the control of the cleaning efficiency during the reprocessing of blood contaminated standard surgical instruments. Other test objects for the monitoring of the cleaning efficiency of complex instruments (i.e. MIS-instruments) and other soils are under development. Take Control of the Cleaning Process Test and document water qualities with AquaChek TM ph Hardness Alkalinity Test for Cavitation in Ultrasonic Cleaners with SonoCheck TM healthmark INDUSTRY COMPANY healthcare products Test the Results of the Cleaning Process with ProFormance TM Test Surface Cleanliness with the ProChek TM protein detection device 39

40 Improving the Quality of by Stephen Kovach Your Sonic Cleaning Process (appeared in Managing Infection Control 2006) Critical Cleaning Cleaning is critical because residual organic material (e.g., blood, bone, proteinaceous material) can inactivate disinfectants; moreover, if a device is not cleaned thoroughly, sterility may not be achieved. Surface cleaning is a crucial aspect of any Central Service (CS) department s cleaning process. Effective cleaning of any surgical instrument is important regardless of the complexity of the instrument. There is no such thing as sterile dirt. Manufacturer Recommendations Almost all surgical instrument manufacturers recommend sonic cleaning in their guidelines for care and cleaning of surgical instruments: Ultrasonic cleaners are used to remove soil from joints, crevices, lumens, and other difficult to access locations. The use of enzymatic detergent in the ultrasonic cleaner is recommended. Ultrasonic Cleaners should be monitored routinely to ensure that they are working properly. An ultrasonic cleaner is recommended. Ultrasonic cleaners can be used with hot water per manufacturer s recommended temperature. In the past, ultrasonic cleaning before decontamination was not recommended. However, it has been found that if visible blood, soft tissue, and bone have been removed, ultrasonic cleaning may be used before placing the items into a washer/sterilizer. Sixteen times cleaner and in 1/50th the hand scrubbing time. One million plus cavitation bubbles imploding within the tank that creates the scrubbing action. Complexity Complicates Just as instruments have become more advanced and complex, so has the sonic cleaning equipment that can be purchased by hospital Central Service departments. These advancements have taken a simple tank with transducers to a level where sonic equipment now can combine the power of irrigation with sonic energy to clean lumen instruments better than ever before (i.e., UltraClean, Medisafe, Custom Ultra Sonics ). Add to this the advancements that have been made with cleaning solutions, and today many sonic equipment manufacturers claim they can: Increase productivity of SPD technicians, Improve consistency of cleaning in internal areas of surgical instruments, Reduce risk to staff from airborne and blood-borne pathogens created by manual brushing, Improve patient care by reducing risk of exposure to cross-contaminants, Reduce time spent trying to manually clean places that cannot be seen or reached, Reduce internal and external instrument damage caused by manually brushing, tapping, or bending, and Reduce instrument-repair budgets. From an instrument manufacturer s point of view, ultrasonic cleaning is an essential part of the cleaning process and should be used as frequently as possible. Today s CS professionals must understand how sonic clean- 40 October 18, 2006

41 What is Sonic Cleaning? Sonic cleaners are designed for fine cleaning of medical devices, not for disinfection or sterilization. They are used to remove soil from joints, crevices, lumens, and other areas that are difficult to clean by other methods. A sonic cleaner can have a single tank or as many as three tanks in a hospital setting.. In a multi-tank system, the first tank is usually for cleaning, the second is for rinsing and the third is for drying. In a two-tank system one tank cleans and the other rinses and dries. The sonic cleaners used in hospitals work via high-frequency sound waves (usually above 20kH) to produce an effect called cavitation tiny bubbles of vaporized liquid that explode under high pressure. Ultrasonic transducers create this high-frequency sound; these transducers then convert high-frequency electrical power to mechanical energy (vibrations). See Figure 1. Fig 1 This energy is transmitted to the cleaning solution via a bank of t r a n s d u c e r s underneath the machine. The net result of this process is cavitation. Cleaning takes place as the cavitation dislodges soil from the surface, tiny crevices, and other areas that are difficult to clean on contaminated instruments, which are placed in the tank with cleaning solution. Cavitation literally sucks soil off the instrument like a vacuum (Figure 2). Most sonic cleaners have multiple transducers producing the cavitation energy. If one or more of these transducers in not functioning, the sonic cleaner tank can have what are known as cold spots - areas within Fig 2 the tank where there is no cavitation. Obviously it is important to know the location of any cold spots. In a machine with several cold spots cleaning time will be extended. Continued, the Sonic Cleaning Process ing works, and are responsible for ensuring that their department s ultrasonic equipment is working properly. Influencing Factors Like any cleaning process, sonic cleaning is affected by outside factors. Factors that influence the effectiveness of sonic cleaning are: 1. Energy created by the mechanical action of the generators and transducers to produce the cleaner s cavitation; 2. Target Soil the type of soil being cleaned; 3. De-gassing freeing trapped air; 4. Chemical activity the type and amount of the cleaning solution chosen; 5. Water quality hardness and ph; 6. Water Temperature hot or cold cleaning solution; 7. Time length of exposure to cavitation; 8. Human factor training, loading procedures, proper use of equipment; 9. Other issues such as pre-cleaning and safety The various combinations of theses factors determine how clean an instrument can or will be when placed inside the bath/solution of a sonic cleaner. The first factor, Energy, is explained in the inset on cavitation (see What is Sonic Cleaning). Now let us look at the other factors: Target Soil Sonic cleaning is used primarily on surgical instruments, so the target soil is usually blood. Many 41

42 Continued, the Sonic Cleaning Process other soils can be present, but blood is a primary concern for the CS department when cleaning surgical instruments. Several characteristics of blood are important to know for cleaning. The first is that hemoglobin becomes highly insolvent when it dries out. Secondly fibrin, the coagulating agent in blood, is inherently water insoluble. Third, blood denatures at temperatures above 113ºF (45ºC). When blood denatures, it becomes highly insolvent. It bonds strongly to the substrate (i.e., the surface of the instrument) and dries out, becoming very resistant to any cleaning action. Thus it is very important to keep Decontamination Holding Time (the time between when the instruments were last used and the cleaning process starts) to a minimum. The sooner the cleaning process begins better. De-gassing De-gassing is the process of releasing dissolved air bubbles within the cleaning solution. In order for the degassing process to work, it must be done with the detergent/enzyme mixed in the bath solution. It is important to expel these air bubbles because they have a direct effect on the ability of the equipment to clean. The air weakens the cavitation force of the sonic cleaner. Degassing is done after the cleaning solution has been added. The amount of time will vary depending on the type of chemical used (e.g. aqueous Target Soil Human Factors or solvent), temperature, size of the tank, and water quality. Generally the process takes as long as one cycle without any instruments in the filled tank. Ask the manufacturer of the sonic cleaner how long it takes to degas a tank full of solution. Remember that degassing conditions the bath/ solution for maximum efficiency and Degassing Ti me should be done for each new fresh bath/solution. If the sonic cleaner has not been used for some time, the solution should be de-gassed because dissolved air can re-enter the cleaner. Chemical Activity Chemical Activity There are many types of cleaning solutions on the market today; each has its plusses and minuses. When choosing a solution, always consider the following: The type of instrument to be Water Quality Temperature cleaned; The instrument manufacturer s recommendation; The type of soil to be cleaned; How well the chosen solution works with your sonic equipment; Technical data (such as white papers) supporting the claims of the solution manufacturer. (MSDS should be provided with any solution. These can be used to evaluate the key ingredients and their possible impact on items being cleaned.) There is a risk that foam may settle on instruments as they are removed from the cleaner. Therefore a low-foaming solution should be chosen. Be aware that excess amounts of certain chemical additives will not support sonic cleaning. More is not always better; if solution must be added manually, use the correct amount. The best solution concentration is indicated on the solution container. Many solutions are concentrated and must be diluted with water. In some cases distilled water may be required. Remember not all solutions are created equal. Some solutions need a higher temperature to work at their optimum efficiency. A solution with many features may not be necessary in a particular CS department. It s more important to know which solution will work best in your depart- 42 October 18, 2006

43 Continued, the Sonic Cleaning Process ment on your instruments. Although blood is the usual target soil on surgical instruments, a different, somewhat slimy soil is commonly found on orthopedic instruments and is hard to clean. It could be synovial fluid; if so, a product that can remove it must be chosen. I can t stress enough the importance of knowing what type of soil is being removed and choosing the appropriate product or products in each case. In some situations two solutions may be required. Water Quality W a t e r quality is a broad concept covering several key characteristics of water. For the CS prof e s s i o n a l the relevant measurable characteristics are ph level and hardness. ph is the measurement of the acidity or alkalinity of a liquid. The scale goes from 1, which is acid to 14, which is alkaline. The mid-point, 7, is neutral. The ph scale is logarithmic; meaning each number in the scale represents a 10-fold increase over the previous number. For example, water with a ph level of 4 is ten times more acidic than water at ph 5. ph level can affect detergent/enzyme performance; thus it is important to know the optimum ph value for the cleaner being used. Water hardness is defined as the concentration of calcium and magnesium ions expressed in terms of calcium carbonate. These and other minerals bind with the cleaning agents in detergents/enzyme solutions and prevent them from reacting with the soil on instruments. Water that is too hard (containing too many minerals) can cause spotting and filming on instruments, and cause unsatisfactory cleaning outcome. The ph and hardness values of water can fluctuate over time. These fluctuations will affect the performance of the solution in a sonic cleaner. Therefore it is important to test and monitor water quality to ensure that optimum values are present. Water Temperature Equally important to knowing water quality is knowing the temperature of the bath/solution in the ultrasonic cleaner. Each solution has a temperature at which it functions best. The solution must be kept at this optimum temperature in order to clean most effectively. The sonic process itself creates heat, and over time this heat can raise the temperature of the bath/solution to a point where it reduces the cleaning efficacy of a particular solution. Remember, hotter is not always better. Achieving the proper temperature and maintaining it throughout the cleaning cycle is key to effective cleaning; thus CS professionals would be wise to monitor temperature during the cycle. Time Cleaning times can very depending on the type of soil, the solution used, water temperature, and the degree of cleanliness desired. Instruments should be visibly cleaner almost immediately after they are placed in a sonic cleaner. The tray /basket used in the machine can affect cavitation energy the instruments receive. The type of tray and the density of the load (number of instruments placed in the tray) is directly proportional to length of cleaning time. With certain trays and loads a standard cycle time might not do the job. Many sonic cleaners have a variable time setting. This is important, be- 43

44 Continued, the Sonic Cleaning Process cause it allows a Central Service department to adjust for the many variables associated with sonic cleaning. Cleaning time is the easiest (and often the wrong) factor to adjust to compensate for process variables. An experienced operator can approximate cycle duration for a certain instrument load, but should validate by actual use with the chosen solution and the actual soiled instruments. An easy way to do this is test a few instruments at a time. CS staff should ask for the instrument and sonic cleaner manufacturers recommendations regarding cleaning time for their products. This information provides Central Service with a starting point from which timing adjustments for particular instruments or soils can be made. Human Factors CS staff should understand how the sonic equipment works; such knowledge is key to ensuring that instruments are safe to assemble and then sterilize. Staff training should involve the following: Demonstration of proper use of sonic equipment by a manufacturer s representative. All shifts must attend a demonstration. Documentation of the in-service/ training. Minimum yearly review of the sonic cleaning process for all staff. Loading instruments into a sonic cleaner is very important so one must: Separate instruments to avoid electrolytic action between different metals (stainless steel instruments should not be mixed with their aluminum, brass or copper counterparts); Remove gross soil from instruments by pre-rinsing prior to sonic cleaning; Do not place chrome-plated and ebonized instruments or items made of cork, wood, and glass in the sonic cleaner; Rinse any prefoam or spray off the instruments; such materials may not be compatible with the cleaning agent used in the tank s bath/solution; Place all box locks in the open position; Fill lumen items with fluid so the cavitation power can work inside the lumen; Spread instruments out over the tray to allow maximum exposure to the cavitation power; If using an irrigation/sonic cleaner, use the correct ports and close off any unused ports. This will allow for maximum flow into the lumen items. Completely submerge instruments in the bath/solution; Make sure the tray/basket is properly located inside the tank. This allows for maximum exposure to the cavitation power. Rinse all instruments after cleaning them in a sonic unit that has only one tank. This is important because residual detergent/enzymes on an instrument is undesirable. Follow manufacturer s directions for the proper rinsing o f the instrument. Consult the manufacturer of the instruments to be cleaned and the sonic cleaner manufacturer for any special instructions. Following these basic loading procedures along with proper in-servicing of the staff will help ensure that instruments are properly exposed to the cavitation power of the sonic cleaning process. Additional Issues Professional opinions vary regarding the need to change the bath/solution in the sonic cleaner. The majority of the manufacturers recommend immediate replacement of water once 44 October 18, 2006

45 Continued, the Sonic Cleaning Process it is heavily contaminated. Contaminated solution can result in a loss of cavitation power. My recommendation is to change the solution as often as needed, preferably after each use. After each change of bath/solution, check the screen or trap and clean off any debris, such as bone chips or paper. Many automatic machines will refresh the bath after each use. Again, the key to effective sonic cleaning is cavitation power. Frequent bath changes help maximize this power, ensuring a better cleaning process. Maintaining the proper level of solution in the tank is also important; sonic cleaning is a fine tuned system. Improper solution levels can Safety Matters Safety is always important when dealing with motorized equipment, including sonic cleaners. All staff should be aware of safety procedures and should be properly attired in the appropriate personal protective apparel (PPA), and should be aware of these safety procedures: When the equipment is being used for cleaning (not testing) the lid must always be closed to prevent excess emission of noise and aerosols. No part of the operator s body should be submerged into the bath/solution during operation. The sonic cleaner should be off when inserting or removing trays/baskets from the tank. Carefully lower trays (do not drop quickly) into the bath/solution. This will minimize or reduce the amount of air introduced into the bath/solution. negatively affect the sonic cleaning process and can damage the cleaner. Sonic cleaning systems were tested with specific volumes of solution. Any amount less will reduce cavitation power. Quality Control for the Sonic Cleaning Process JCAHO and AAMI recommend that sterile processing departments have process performance programs in place: Medical equipment is maintained, tested and inspected. A problem analysis should be completed for any aspect of decontamination that can pose a risk to personnel or patients. The problem analysis should define and resolve the problem and the system should be monitored to ensure that the problem has been corrected. Ultrasonic Cleaners should be monitored routinely to ensure that they are working properly. Recommended monitoring methods are: 1) Sonocheck monitoring vials (from Healthmark Industries Co., East Nine Mile Road, St. Clair Shores, MI USA) which change color when the ultrasonic cleaner is supplying sufficient energy and conditions are correct. 45 2) Aluminum Foil Test (Reference: The Aqueous Cleaning Handbook: A Guide to Critical-Cleaning Procedures, Techniques, and Validation, Alconox, Inc. 2002, 3rd Edition, WhitePlains, NY, pps ) The Organization for Safety and Asepsis Procedures (OSAP) is a global dental safety organization and they recommend routine testing of sonic cleaners. The FDA considers the sonic cleaner a Class 1 medical device. The cleaner must be maintained in proper working order, and CS staff need to know whether or not it is working properly. One of the best ways to ensure that the machine is functioning properly is to establish a quality improvement program for the sonic cleaning process. A quality improvement process helps ensure adherence to both JCA- HO and AAMI standards. Testing is a key component of a quality improvement program. Tests provide a means of monitoring the variables that affect the effectiveness of sonic cleaning (i.e. water quality, time, detergent/enzymes, temperature, agitation, speed, initial temperature, chemical concentration, equipment failure.) Ultrasonic cleaners should be tested at least weekly, and the results of the test should be documented. Tests fall under two categories: periodic functional tests and routine tests. A periodic functional test is performed for initial set-up and then quarterly or after repairs. Its purpose is to verify uniform distribution of

46 Continued, the Sonic Cleaning Process cavitation in the sonic cleaner. Uniform distribution of sonic cavitation within the bath ensures satisfactory performance by the cleaner and allows performance of routine testing. A periodic functional test can be used to fine-tune the ultrasonic cleaning process if results are found to be unsatisfactory. It also helps identify cold spots in the tank. (See Figure 3 for placement of testing devices.) x x x x x A routine test is performed weekly to verify that proper cavitation is taking place. Such parameters as water level, de-gassing, instrument load, and energy supplied by the transducers can cause variations in the process that affect performance. Only routine testing will detect ultrasonic performance deterioration and prevent ineffective ultrasonic cleaning. The routine test is performed under normal conditions in an empty tank. (See Figure 4 for placement locations for individual tests.) x The following is a simple program for monitoring the sonic cleaning process. Sterile processing departments should include it as part of their JCAHO process improvement program. Inspection & Testing Daily: Follow manufacturer s guidelines for daily inspection of equipment (wipe down tank at end of day, check gaskets, clean screens, etc. ). Inspect the level of detergent. Each day, mark the date on the solution container at the level x x x x x x x x x of solution r e m a i n - ing. This will allow staff to see how much solution is being used. Log all observations in a report. Report any concerns to be addressed to the proper management staff. Weekly: A complete test of all inputs of the ultrasonic process should be run each week. Observations and test results should be entered in a log/report. Step 1-- Equipment Inspection: Inspect equipment (screens, gaskets, etc) according manufacturer instructions. Record results. Step 2-- Water Quality Inspection: Measure hardness and ph of the tank bath/solution before adding cleaning solution (simple dip stick method can be used). Record results, and report any concerns to the proper management to address. Step 3-- Water Temperature Inspection: Measure the tank bath/solution temperature with a liquid reversal thermometer. The thermometer should be applied to the inside of the tank wall just below the water line. Record results on log sheet, and report any concerns to the proper management staff. Step 4 Test sonic cleaner performance: CS staff have traditionally chosen one of four methods- - a pencil load test, an aluminum foil test, and ultrasonic activity detector, and a SonoCheck TM -- to test sonic activity in the cleaning tank. Each will be described in this section. In each case, test results should be recorded and then compared with results of the same test conducted when the cleaner was originally installed. In case of unsatisfactory test results, refer to the troubleshooting guide supplied by the manufacturer of the particular test being used. Any concerns should be reported to the proper management staff to address. In a pencil load test (also known as the ceramic disc test), the surface of an unglazed ceramic disc or plate having a matte finish and a diameter of approximately 50 mm (thickness is not critical) is rubbed with a standard HB lead pencil and then immersed in the cleaning tank. Consistent, equal application of the lead onto the disc every time is very important. (The Steris Company has recommended this method in the past, but the disks are no longer available. ) 46 October 18, 2006

47 Continued, the Sonic Cleaning Process A ground glass stopper, a sheet of ground glass, or an aluminum sheet with a thickness of 2-3mm may be substituted for the ceramic disc. The ultrasonic cleaner should completely remove the pencil lead within three minutes. A strip of aluminum foil can also be used to test a sonic cleaner. Several tests using aluminum foil have been described in the literature. Recommendations vary regarding the thickness of the foil strip, but it should be at least.025 mm. One test recommends suspending nine strips of aluminum foil, 15mm to 20 mm wide, within 10 mm of but not touching--the bottom of the tank. Another method is to take three pieces of foil, each measuring cm, and fold them over rods suspended in various areas of the tank. The presence of significant pitting and a uniform pattern of dents and holes in the foil strips after cleaning indicate the unit is working. Testing can also be done with an ultrasonic activity detector, a device developed to determine ultrasonic activity levels. The device consists of a stainless steel probe with a plastic handle and connecting cable. The cable plugs into a hand-held instrument that indicates and monitors ultrasonic activity. The probe is placed into various sections of the tank and measurements are taken for each spot tested. The fourth testing method, the SonoCheck TM (See Figure 4 & 5), is a chemical indicator vial that verifies the cavitation capability of the ultrasonic bath. The test device is a closed vial containing fluid and glass beads. The vial is placed in the sonic bath, which then is switched on. When effective cavitation is achieved, the color of the fluid in the vial changes from green to yellow. The length of time it takes to change color is proportional to the cavitation power of the sonic cleaner. The person conducting the test records the amount of time that elapses prior to the color change. Each of these test methods has its pluses and minuses. A central service department must determine which test is best suited for its particular needs, and then use the chosen test as part of a quality improvement program. Criteria for selecting a test include: Ease of use and interpretation of results-- results should be objective. Subjective results can lead to misinformation about the equipment. Availability and cost; Correlation to cavitation; and Reliability and reproducibility of the test results. Information gleaned from running the test should help resolve concerns; i.e. Is the process working? If not, how does the test method help resolve the problem? Soil Test Recently a new type of test has become available as an option for evaluating the sonic cleaner s effectiveness; namely, a soil test. A soil test contains a soil sample that must be completely removed by the sonic cleaning process. As stated previously in this article, blood is a primary target soil for the sonic cleaner. Logically therefore a soil test should contain a sample of this target soil. Two types of test kits containing blood or a blood substitute are available today a paint-on type such as an Edinburgh soil, and the TOSI, a prepared test object. The paint-on soil is spread over the instruments being tested. The soil must be applied consistently each time the test is performed. The soil is allowed to dry (follow manufacturer s instructions regarding length of drying time), and the instruments are loaded into the sonic cleaner using a normal loading pattern. A visual inspection of the instruments is 47

48 Continued, the Sonic Cleaning Process required after the sonic cleaning process. Results are recorded and interpreted according to the soil manufacturer s guide. The TOSI (Test Object Surgical Instruments; see Figure 6) has three components: the blood soil, a stainless steel plate, and a clear plastic holder. The soil is composed of blood components mixed and applied in a precise manufacturing process, which provides a consistent challenge to the effectiveness of the sonic cleaner. The stainless steel plate is scratched or grooved, replicating the uneven surface of surgical instruments. The plate is mounted in the plastic holder at an angle, providing a gradually more difficult cleaning test from one end to the other. During the test one TOSI is placed inside an empty approved tray/basket for one cycle length. Users should follow manufacturer s instructions and refer to the troubleshooting guide in case of unsatisfactory results. Results of the test are recorded, and concerns reported to the appropriate staff for follow-up. Just as with the sonic energy tests described above, CS staff must determine the best test method for their particular facility, and then use the chosen test in their quality improvement program. Criteria for selection include: Ease of use and interpretation of results; Consistency of application of the test; Availability and cost; Correlation of test soil with human blood; Reliability and reproducibility of the test results; and Ability of the test to identify and resolve concerns regarding cleaning effectiveness. Testing for Hollow/Lumen Instruments Many of today s advanced sonic cleaners have the ability to irrigate hollow instruments, allowing the Central Service department to better clean lumen items. (Refer to the article Manual versus automated methods for cleaning reusable accessory devices used for minimally invasive surgical procedures ). A new test, the LumCheck (See Figure 7,) can be used to evaluate the cleaning performance of sonic equipment that irrigates lumen items. The test consists of a capsule with lumens on either end, into which a TOSI test strip is inserted. The dimensions of the test capsule are similar to those of long hollow instruments. Users should read the manufacturer s instructions for hooking up lumen/hollow instruments to the equipment, and use the same procedure to hook up the test device. Run a complete cycle and record the results. In case of unsatisfactory results, refer to the troubleshooting guide for the Lum- Check. Report any concerns to the appropriate management staff for follow-up. As of this publishing the author was not aware of methods other than the LumCheck available to hospitals for testing lumens. Authors note: Our data demonstrate that the lumen TOSI is a relatively easy challenge and if residual material remains, it indicates that the lumen cleaning ability of the washer has been severely impaired (less than ½ usual conditions). Equipment Maintenance After any maintenance is done on the sonic equipment, all tests should be conducted to ensure that the equipment is functioning properly. The type of maintenance done and the results of all tests should be documented and recorded. The person who performs the maintenance should not leave until the tests have been completed, so that necessary adjustments can be made immediately. 48 October 18, 2006

49 Continued, the Sonic Cleaning Process True or False: Test Questions Summary A quality improvement program for the sonic cleaning process should include the following : Measuring ph and water hardness Monitoring the bath/solution temperature Performing a cavitation test on the equipment Performing a target soil cleaning test Perform an appropriate lumen test on cannulated/lumen type cleaning equipment Daily/weekly visual inspection of equipment (observations of machine operation/conditions) Constant daily visual inspection of all instruments Training of staff on a continues basis Record all results of test and observations in a log /book In case of unsatisfactory results refer to the troubleshooting guide for the tests and equipment used Focus Staff Training On... De-gassing procedure Loading of instruments Selection of trays Other key factors / inputs relevant to each hospital s process Report any concern to the proper management staff within the department to follow up. Today s Central Service departments are very active and dynamic. Surgical instrumentation and processes change constantly, and the cleaning equipment needed to process these instruments safely is evolving as well. It only makes sense to have a well-qualified and trained staff to process these surgical instruments. A sonic cleaner, like any piece of equipment, can malfunction at any time. Knowledge of when and why the cleaner is malfunctioning is key to ensuring properly cleaned surgical instruments. A quality improvement program helps ensure that staff are protected and patients are receiving the best possible care. It enables CS staff to know that their equipment (in particular, the sonic cleaner) is working properly. Then staff can be sure that the instruments are clean and ready for the next stage of the reprocessing cycle According to AAMI ST 35, sonic cleaners are meant only to clean, not to sterilize and disinfect. True False 2. A surgical instrument that is not properly cleaned could fail in the sterilization process. True False 3. Degassing conditions the bath/solution for maximum efficiency and should be done for each new fresh bath/solution. True False 4. Decontamination Holding Time (DHT) is the amount of time that elapses between an instrument s last use the start of the cleaning process. True False 5. Improper water temperature could cause less than optimum function by an enzyme/detergent solution. True False 6. The dilution rate of the solution used in the sonic cleaners tank can affect instrument cleanliness. True False 7. Sonic cleaner operators should never put their hands inside a working (running) unit. True False 8. Monitoring the key factors of the sonic cleaning process helps ensure that surgical instruments are getting clean. True False 9. Both JCAHO and AMMI encourage the use of quality improvement programs within Central Service. True False 10. If a sonic unit has only one tank, rinsing is very important Residual detergent/enzymes on instruments is undesirable. Follow the detergent manufacturer s directions for complete rinsing of its product off instruments. True False Answers 1) T; 2) T; 3) T; 4) T; 5) T; 6) T; 7) T;8)T; 9) T; 10) T.

50 The importance of Tray Selection to the Ultrasonic Cleaning Process by Stephen Kovach and Denis Coatesworth (appeared in Managing Infection Control 2006) The best method for thoroughly cleaning delicate micro-instruments is to use an ultrasonic cleaner. 1 Most instrument manufacturers recommend ultrasonic cleaning as the most effective way to clean surgical instruments, particularly those with hinges, locks, and other moving parts. 2 Ultrasonic Cleaners should be monitored routinely to ensure that they are working properly. 3 Without thorough cleaning, sterilization cannot take place. Sterile processing professionals have several choices when it comes to cleaning instruments: manual cleaning, cleaning with an automatic washer (batch or tunnel type), ultrasonic cleaning, or combinations of all three. Each process has its advantages. Regardless of which type of cleaning method is chosen, cleaning performance is highly dependent on mechanical action, chemical selection, temperature, water quality, instrument design, and staff training. All parameters play an important role in a successful outcome-- clean instruments. In a recent article in Zentral Central (Volume 12, 2004) entitled Recommendations by the Quality task Group (33) Mesh trays and their implications for successful cleaning in the washer disinfector, the authors note, Apart from the quality and type of load, the design of the mesh trays also has implications for successful cleaning in the washer disinfector. The article s conclusion states, To optimize the cleaning results, the choice of mesh trays and storage aids should not be underestimated. The Zentral Central article led us to wonder whether the same conclusion would apply to ultrasonic cleaners. Would the selection of a basket/ tray have a direct effect on the ultrasonic cleaning process? Purpose of this Study Cavitation is the force behind the cleaning by any ultrasonic equipment. We wondered whether different types of baskets would affect cavitation. Would some trays impede or slow the cavitation process? Our goal was to create a test method that could be reproduced in any Central Service Department and that would show whether tray selection affects the cavitation energy of ultrasonic cleaning. Overview of Ultrasonic Cleaning According to the FDA, an ultrasonic cleaner is a Class 1 medical device listed under code According to AAMI, ultrasonic cleaners are designed for fine cleaning of medical devices, not for disinfection or sterilization. 4 An ultrasonic cleaner enables thorough cleaning of equipment by ultrasonic agitation that dislodges soil from instruments. Ultrasonic cleaners work by subjecting instruments to high-frequency, high-energy sound waves transmitted through an aqueous solution. The high-frequency sound is above 20 khz to produce an effect called cavitation. Cavitation is the creation of micro-vacuums (air pockets) within the aqueous solution that then collapse at a very rapid rate. This has the result of exploding soil off of solid surfaces. The purpose of the ultrasonic cleaning process is to clean dirty surgical instruments so they can be handled safely, repackaged, and sterilized for a future surgery. The danger of handling instruments contaminated with blood is obvious in this age of hepatitis, CJD and HIV. The procedures for sterilizing instruments are based upon years of scientific testing with clean instruments. If surgical instru- 50 October 18, 2006

51 Tray Selection, continued ments are not clean, the sterilization methods are ineffective. Dried blood on instruments is hazardous to the employees of the hospital and to the next surgical patient upon which the instruments are used. Key Inputs to Ultrasonic Cleaning The high frequency (ultrasonic) sound is created by transducers, which are piezoelectric crystals that convert electrical power to mechanical energy (vibration). The effective range of a single transducer is very short, so a bank of transducers is arrayed underneath the tank to transmit this energy throughout the cleaning solution. The result of this process is cavitation. Cavitation causes the soil to be dislodged from instruments and drop to the bottom of the tank, or be sufficiently loosened that it will be removed during the rinsing process. Without sufficient cavitation, instruments cannot be effectively cleaned. The detergent used in the ultrasonic tank must be carefully selected in accordance with advice from the manufacturer. Optimally it will be a neutral, low-foaming product; enzymatic cleaners will have enhanced benefits in this process. Along with the detergent, water quality (e.g., hardness and ph level) will impact the cleaning performance. Degassing of cleaning solutions is extremely important in achieving satisfactory cleaning results. Degassing is a process that eliminates air that is trapped in solution when fresh solution is added to the bath. Degassing conditions the bath for maximum efficiency in a minimum period of time. Fresh solutions or solutions which have cooled must be degassed before proceeding with cleaning. The degassing process is done after the chemical is added and is accomplished by operating the ultrasonic energy and raising the solution temperature. The time required for degassing varies considerably, based on tank capacity and solution temperature. Degassing is complete when small bubbles of gas cannot be seen rising to the surface of the liquid and a pattern of ripples can be seen. It is our assumption that even if the sonic cleaner is calibrated properly and all of the proper steps (degassing, temperature control, loading, detergent selection, water quality, etc.) are taken, the selection of the tray to be placed in the ultrasonic cleaner would have a direct effect on the outcome, which is a clean instrument. Tray / Basket Importance Tray selection is an important step in ultrasonic cleaning. Because of the vibration energy an ultrasonic cleaner produces, instruments cannot rest on the tank bottom. A heavy/sharp/ hard instrument that is dropped into a tank can damage a sonic cleaner. Use of a basket/tray is important in order to prevent damage to the transducers and to protect the tank from scratches. The baskets/trays used to hold the parts should not absorb any ultrasonic energy. Baskets, trays, and racks made from heavy and dense material (including soft material such as rubber, silicone, wood and fabric) should not be used, as they will absorb ultrasonic energy and reduce cleaning effectiveness. 5 Size is an important factor in tray/ basket selection. The sum of a part s cross-sectional area should not be greater than 70 percent of the ultrasonic tank s cross-sectional area. 6 In the same vein, Instruments should not be crowded in the tray/basket. Overloading will result in less-than- 51

52 Tray Selection, continued optimum cleaning performance. Care must be taken to ensure that all areas of the instruments being cleaned are flooded with the cleaning liquid. Lumen-type items need to have fluid inside of them in order to receive the full impact of the ultrasonic cleaning process. 7 Trays/ baskets and fixtures must be designed to allow penetration of ultrasonic energy and to position the instruments to assure that they are exposed to the ultrasonic energy. It is often necessary to individually rack parts in a specific orientation or rotate them during the cleaning process to thoroughly clean internal passages and blind holes. 8 Study Design We wanted to develop a test that a Central Service Department could repeat in its own facility. Our study was designed to control all the key factors in the ultrasonic cleaning process except the basket used. Selecting the proper test for cavitation activity The first step in designing the test was to choose a method for testing cavitation activity. After an extensive literature search to identify test methods used by others, we determined that our test method should fit the following criteria: The procedure must be able to be reproduced independently by the staff of a typical hospital Sterile Processing Department. The test must be relatively easy to use. In consideration of the limited resources of a hospital Sterile Processing Department, the test method must avoid use of expensive laboratory equipment and supplies, as well as equipment not readily availability to an SPD. The test method must produce results that are purely objective, with no component of subjectivity. After querying various manufacturers of ultrasonic cleaners, we determined that no standard test method existed for evaluating cleaner performance. Most manufacturers seemed to feel that performance evaluation was the responsibility of the customer, who obviously knows if any equipment performs the cleaning job satisfactorily. Most ultrasonic cleaner manufacturers ensure that their equipment is operating satisfactorily by running the equipment from 4 to 24 hours continuously prior to shipment. No cleaning test is performed during this operation. 9 Research did identify four methods that have been used to test the performance of an ultrasonic cleaner: 1. Pencil load test (also known as the ceramic disc test): The surface of an unglazed ceramic disc or plate having a matte finish and a diameter of approximately 50 mm (thickness is not critical) is rubbed with a standard HB lead pencil and then immersed in the cleaning tank. A ground glass stopper, a sheet of ground glass, or an aluminum sheet with a thickness of 2 3 mm may be substituted for the ceramic disc. The ultrasonic cleaner should completely remove the pencil lead within three minutes. We rejected this method for a couple reasons. While the test is inexpensive and easy to conduct, in order to produce an objective measure of performance it is necessary to accurately measure and meter out the amount of lead on the ceramic disc. This would require use of an expensive weight scale. Without such a scale, test results would rely upon a subjective judgment of lead levels. A further complication is that while at one time the Steris Company, a leading supplier of ultrasonic cleaners for healthcare facilities, recommended this method, it no longer sell the discs, and we could find no other supplier for them Aluminum foil test: A smooth 52 October 18, 2006

53 Tray Selection, continued piece of aluminum foil can monitor the cleaning effectiveness of an ultrasonic cleaner. Each piece of foil should be approximately mm thick and extend to approximately 6 mm clear from the sides and bottom of the tank. It must be suspended in the cleaning solution extending the full width and depth of the solution. The unit is activated, and after seconds, the foil can be removed and examined. The presence of significant pitting and a uniform pattern of dents and holes indicate the cleaning unit is performing properly. The test is also compared to an original foil test done on installation to ensure that the equipment is working properly. 11 Like the ceramic disc test, this method is easy to perform and inexpensive, but also would require use of an expensive weight scale in order to accurately and objectively measure the test results. Without use of a scale, the user is forced to compare the pitting of one aluminum sheet versus another, a very subjective measure of performance. 3. Ultrasonic Activity Detector: This test consists of a stainless steel probe, fitted with a plastic handle and connecting cable, which plugs into a hand-held instrument that indicates and meters the presence of ultrasonic activity. This was developed to determine ultrasonic energy levels. 12 While this method eliminates any subjectivity in the test results, it is very expensive. These detectors cost thousands of dollars and realistically would not be purchased by or available to a hospital Sterile Processing Department. 4. SonoCheck TM : This test monitors the ultrasonic energy level during the cleaning of surgical instruments. Ultrasonic cleaning relies on the occurrence of cavitation. When cavitation occurs, it triggers the chemical reaction in the Sono- Check TM, changing its color from green to yellow. Factors such as insufficient energy, overloading, water level and de-gassing will increase the time needed for the color change. In the case of a total machine failure, the SonoCheck TM will not change color at all. Of the methods reviewed, this test seemed to best fit our criteria. SonoCheck TM s are readily available for purchase. 13 At a cost of approximately $6 per test, they are relatively inexpensive. The tests can be easily placed in the ultrasonic cleaner, and if care is taken, placed in the exact same locations each and every time. The result is a standard chemical reaction; the measurement of result is the amount of time the test takes to change color. Other than the test itself, the only device needed is a stopwatch or similar readily available timing device. Tray Selection Four different trays were selected for trial: one open-weave, one solid-side, one small-weave, and one plastic. The test was conducted with empty baskets/trays to isolate the impact each tray had on the sonic process and to help determine the best one for the equipment used. Materials Used Steris Ultrasonic Washer, model #SC122CD, purchased in 1993 SonoCheckTM ProEZ 2 dual enzymatic, manufacturer Certol, 2 oz/ gallon Instruments baskets as noted in tray selection above Procedure Ensure that the ultrasonic cleaner has been degassed prior to running the test. Place nine (9) SonoCheck TM s in an empty tray (See Fig. 1) 53

54 Tray Selection, continued Run Ultrasonic through normal cycle (use time recommended in operator s manual) and record results. Record the amount of time each SonoCheck TM takes to change from green to yellow (can occur as quickly as 10 seconds). If a color change did not occur by the end of the cycle, report that result. Note: The amount of time of ultrasonic processing needed to generate the color change will provide additional information about the ultrasonic energy and caviation generation. Repeat three times for each tray. Results The SonoCheck TM was used to show cavitation by way of color change in all tests. Results were recorded based on the time it took to change the SonoCheck TM from green to yellow. Each tray was divided into nine sections and a SonoCheck TM was placed in each section. The color change time was recorded for each section. The tests were repeated three times for each tray. The color time change results were used to evaluate each tray s ability to allow cavitation: the average overall time, average minimum time, and average maximum time. The average overall time (to change the SonoCheck TM from green to yellow) is the average of all three tests in all nine sections (27 SonoCheck- TMs). The average minimum time (to change the SonoCheck TM from green to yellow) is the average of the lowest recorded times of the three tests for each position. The average maximum time (to change the SonoCheck TM from green to yellow) is the average of the highest recorded times of the three tests for each position. Tray Type #1 / Open- weave The open-weave tray/basket had the best overall results, including best average overall time (48.19 seconds).and best average maximum time (57.22 seconds). It was second in average minimum time (39.33 seconds). The results indicate that the open-weave basket allowed the best penetration of the cavitation energy. All three tables support this conclusion. Tray Type #2 / Solid-side The solid-side tray/basket, which seems to be the most popular in CS departments, performed second-best overall. Its average overall time (67.96 seconds) and average maximum time (91.33 seconds) were second. The average minimum time (47.00 seconds) was third. Tray Type #3 / Small-weave Although the small-weave tray/basket had the best average minimum time (38.99 seconds), its overall all rating was third, scoring behind the open-weave and solid-side baskets in average maximum time ( seconds) and average overall time (71.37 seconds). Tray Type #4 / Plastic Tray The plastic tray/basket had the highest times in all categories, placing it last among trays tested. The average overall time was seconds; average minimum time was seconds and average maximum time was October 18, 2006

55 Tray Selection, continued Discussion & Conclusion Our results indicate that an openweave basket allows the best penetration of sonic energy (See Table 1). The plastic tray/basket had the poorest overall result; thus we do not recommend this type of tray for ultrasonic cleaning. The literature sited earlier also advises against using plastic trays/baskets because plastic can absorb ultrasonic energy, thereby reducing the cleaning power of the ultrasonic process. The test conducted in this study can be conducted on any sonic cleaning equipment. Regular testing will improve Central Service Department s ability to check for cavitation activity. Of course, staff training is critical to proper implementation of the test. Staff must be educated in proper use of the sonic cleaner, including loading technique. Overloading will have a negative impact on the cleaning process. The Central Service (CS) Department is a critical area in the hospital environment. With many new technical and delicate instruments under their watch, CS professionals must consider the specific cleaning guidelines of each manufacturer, and they must test their equipment routinely. Our study shows that if ultrasonic cleaning is the preferred method, CS professionals must select the tray that works best in the ultrasonic cleaner to produce the desired results CLEAN INSTRUMENTS. Tray Type Open weave basket Tray Type 1 Solid Side Basket Tray Type 2 Small Weave Tray Type 3 Plastic Tray Tray Type 4 Test and document water qualities with a single test ph Hardness + Alkalinity Test for Cavitation in Ultrasonic Cleaners with SonoCheck TM + before Test Water Purity with an ATP Test Test Surface Cleanliness with Protein/ATP + Detection With ProFormance TM Test the Results of the Cleaning Process after Average Time Average Minimum Time Table 1 Average Maximum Time The Verification of Clean is Coming. Do not Miss the Train! healthmark INDUSTRY COMPANY healthcare products 55

56 ASTM Publishes New Guideline: D7225 Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors Ralph J. Basile It is axiomatic, if a surgical instrument is not clean, it can not be rendered sterile. Ask any Sterile Processing professional, if given the choice, would they rather have surgery performed on them with instruments that have been thoroughly cleaned but not sterilized; or have surgery performed with instruments that were not adequately cleaned but were sterilized? Invariably, these professionals will take the former. What these professionals know is that 99+% of contaminants are removed by cleaning. The recognized standard for cleaning in the healthcare industry is the so-called visual standard. This standard relies upon the observation skills of the reprocessing technician to determine the suitability of instruments after cleaning. This is an important facet to effective reprocessing, but as with sterilization, methods and tests which provide an objective challenge or test to the successful cleaning of instruments would be a valuable resource to the Sterile Processing practioner. It was the development and review of such a method that resulted in the recently published ASTM Standard Guide #D7225. Who Is ASTM ASTM International is one of the largest voluntary standards development organizations in the world. It is a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy. As part of that charge, ASTM recently developed and published a standard method for the purpose of challenging the blood cleaning efficiency of detergents and instrument washers. This method was written in the form of a guide meaning that it is not exclusive to any other method, but has been peer reviewed and found a viable method to achieve this purpose. ASTM Committee D12 on Soaps and Other Detergents was formed in 1936 and has jurisdiction over standards related to the promotion of knowledge, stimulation of research, and the development of specifications, methods of sampling, methods of tests and analysis, definitions and nomenclature, and recommended practices related to cleaning with soaps and detergents. These standards encompass important aspects including: composition, sampling, properties, classification, (appeared in Managing Infection Control 2006) nomenclature, analysis, and quality assurance. Sub-committee D12.16 is focused on hard surface cleaning and was thus assigned responsibility for development of this method for cleaning blood from the surface of surgical instruments. Rationale for this Method Dried blood represents the greatest challenge to the cleaning of surgical instruments (AAMI ST ). The water-soluble components of blood are easily rendered insoluble when exposed to heat, chemical solutions, or time at room temperature. The water insoluble components of blood are the coagulating agents (e.g., fibrin). These proteins bind quite readily to the surfaces of surgical instruments making them difficult to remove even with the aid of chemical cleaning agents. Instruments contaminated with blood soil represent a significant threat for contamination of healthcare workers and patients. Healthcare facilities typically employ the use of automated instrument washers. These devices combine mechanical action along with chemical cleaning agents in a staged cleaning cycle designed to thoroughly clean 56 October 18, 2006

57 Quotes on Cleaning from Regulatory Bodies D7225 Standard Guide for Blood, cont d The FDA document Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors; Guidance for the Medical Device Industry and FDA Review Staff states, The FDA believes that a safe and effective system for cleaning and disinfecting medical devices is important in protecting the public health. (February 7, 2002). The CDC s recommendations can be found at its Handwashing and Hospital Environmental Control page: Cleaning is the necessary first step of any sterilization or disinfection process If the surface is not cleaned before the terminal reprocessing procedures are started, the success of the sterilization or disinfection process is compromised. Darlene Christiansen, Director of Standards Interpretations and the Office of Quality Monitoring for JCAHO, states, Sterile Processing is an integral part of the care process, so it s important to assess that equipment is being properly maintained, chemicals are being used properly, infection control and (safety) measures are being applied appropriately and that there is proper ventilation, for example. AAMI ST 35 states: Effective cleaning is a multistep process that relies on several interdependent factors: the quality of the water; the quality and type of detergent; an acceptable washing method; proper rinsing and drying; correct preparation of items to be processed by cleaning equipment; the time and temperature parameters and load capacity of the equipment; and operator performance. surgical instruments, including areas of instruments which are not easily observed (e.g., box locks). To function properly, these machines must be performing at targeted mechanical efficiency; deliver the correct chemical cleaning agents; at the correct temperature; with the correct dosage; for the correct period of time. Failure to deliver these parameters will lead to a less than optimal cleaning process. ASTM D7225 suggests related methods for challenging the removal of standardized test soil as a result of mechanical or chemical action, or both, by the tested detergents or washer-disinfectors, or both. One method involves the use of a stainless steel coupon with dried blood soil held in a plastic holder. When followed, this method provides the user with a qualitative evaluation of cleaning efficiency. Another method utilizes a peroxidase reaction with hemoglobin to test for residual blood soil on presumptively cleaned surfaces. Description of Test Methods Dried Blood Soil on Stainless Steel Coupon A commercially available product, the TOSI (Test Object Surgical Instrument) is designed in compliance with ASTM D7225 and is illustrative of a test that could be used to implement this method. Manufactured to ISO Standards, this commercially 57 available product provides a consistent, repeatable, standard challenge to the cleaning efficacy of an automated instrument washer. As described in ASTM D7225, this test product is made up of three components: The blood test soil, the stainless steel plate, which is mounted in a clear plastic holder. The blood soil is made up of the components of blood the most difficult to clean: dried hemoglobin, dried albumin and fibrin. The stainless steel plate is scratched or grooved, replicating the uneven surface of surgical instruments. The plate is mounted in the clear plastic holder at an angle, providing a gradually more difficult cleaning test from one end to the other allowing visual inspection of areas that are analogous to those of surgical instruments not usually seen (e.g. box locks). The regular, periodic implementation of this test method with a blood soil coupon (commercially pur-

58 D7225 Standard Guide for Blood, cont d chased, or produced by the user) is a systemic challenge to the functioning of an automated washer. The components of blood correlate to the state of dried blood on instruments. The physical barrier of the plastic holder is analogous to the physical barriers represented by cracks and crevices of instruments (e.g., box locks). Following the test method, users consult an interpretation guide that aids them in evaluating results that are less than optimal. For instance, failure Peroxidase Reaction with Hemoglobin versions of this test are available for users not wishing to create their own test kit. The Hemocheck is designed for testing the outer surface of instruments. The EndoCheck is available for testing flexible endoscopes. These commercial versions include a vial containing diluted hydrogen peroxide, diluted TMB and a suitable cotton swab. Blood in box lock of instruments Residual blood soil on test coupon indicating poor cleaning efficiency Moistened cotton swab is passed through the biopsy channel of flexible endoscope to capture residual blood soil Cotton swab is placed in vial containing hydrogen peroxide. Second vial containing developing agent will be added to check for color change indicating blood soil. to remove the fibrin layer of blood soil (which is water insoluble) indicates a problem with the chemical cleaning agent(s). Failure to evenly remove hemoglobin soil indicates poor mechanical efficiency. Failure to remove any soil indicates either a catastrophic mechanical failure, or inappropriate settings for the initial rinse stage (e.g., the cold water rinse is too hot rendering the hemoglobin insoluble). With this method, the user is able to conduct an informed investigation in order to isolate the source of the problem(s). Conversely, if the coupon comes completely clean, the user has an objective confirmation that the instrument washer is in proper working order. Independent studies have demonstrated that blood soil can remain on the surface of surgical instruments that are below the threshold for visual observation by decontamination staff. Given the critical nature of cleaning to the overall successful decontamination of surgical instruments, testing for residual blood soil with a highly sensitive test to determine the cleanliness of surgical instruments is valuable. A well-documented and widely utilized method for detecting blood utilizes hydrogen peroxide that interacts with hemoglobin. This reaction can be made visible (e.g., color change) by addition of developing agent. The method recommended is to use a clean cotton swab to sample nontransparent lumens or surfaces. A solution of tetramethylbenzidine (TMB) in acetic acid is mixed with a diluted solution hydrogen peroxide. The swab is introduced to this solution. If blood residue remains, it will be indicated by a blue color reaction. Visible color change will occur at 0.1µg or greater. Two commercial Who Should Use this Method Historically the Sterile Processing Department of Healthcare Facilities has relied upon a visual inspection of instruments to determine cleanliness. While it will always be necessary to be vigilant in observing the condition of instruments exiting the instrument washer, relying solely upon a subjective and non-standard method for evaluating an equipment s performance easily leads to a failure to identify problems. A method that involves the use of a standardized test object and following the same procedure for testing the washer provides the Manager of Sterile Processing Department a method for objectively 58 October 18, 2006

59 D7225 Standard Guide for Blood, cont d Take Control of the Cleaning Process Test for Cavitation in Ultrasonic Cleaners with SonoCheck TM Test and document water qualities with AquaChek TM ph Hardness Alkalinity monitoring the cleaning performance of the automated washer on a rote, periodic basis. Machine process failures can be more quickly and easily identified, diagnosed and resolved. Further, the periodic and random testing of actual surgical instruments having passed through the decontamination process for residual blood soil can provide greater confidence in and documentation of the successful reprocessing of all instruments. ASTM Standards can be ordered individually or in compendiums from ASTM at www. ASTM.org. Monitor and D o c u m e n t Water Temperature with Tempachek TM irreversible thermometers Test the Results of the Cleaning Process With ProFormance TM Test Surface Cleanliness with a protein detection device healthmark INDUSTRY COMPANY healthcare products

60 On borrowed time: Caveat emptor with loaner devices by Stephen Kovach (appeared in Healthcare Purchasing News 2006) As the educator for a major infection control products company in the United States, I interact with a diverse cross-section of healthcare professionals. During these interactions I am made aware of the latest hot topics issues that everyone in the industry is talking about. Recently, I ve noticed the hottest topic is loaners the increase in their use and the concerns their use raises for the central service department. These concerns are illustrated in the following questions that have been posed to me: How can I verify my sterilization time for these items? How did the company determine that the sterilization time is 30 minutes? This tray has three levels how can I get the bottom level clean? Do I take the items out of each level? Why didn t the representative bring the items in earlier? Two hours is not enough time to get them ready. These trays do not look clean. I didn t even know loaners were needed for this case how did they arrive? Should I leave the lid on the trays when they go into the automatic washer? The representative added items to the tray. Do these changes affect how it was validated for sterilization? I have never seen this tray before. How do I clean and sterilize this tray? Why have loaners become such a hot topic? What is so frustrating about bringing in a set or sets of surgical (mostly orthopedic) instruments for a case? A recent AORN Journal published the following questions from a reader: Can you provide guidelines for borrowing instruments and equipment? Is using instruments or equipment brought in by a vendor covered by a different set of standards? The peer reviewed Journal s response was summarized in its final two sentences: The primary responsibility of a perioperative nurse is to protect patients from harm. By facilitating best practices for sterilization of borrowed instruments and equipment, perioperative nurse, will minimize patients risks associated with infection. Hospitals perspective To determine how hospitals obtain loaner instruments for surgical cases and the procedures they follow, I conducted a snapshot survey on loaners in December I ed the survey to 50 various operating room (OR) and central service (CS) professionals and received 26 replies. For the purposes of this survey, the term loaner is defined as a surgical instrument(s) or implant(s) borrowed by the hospital from a vendor for a specific surgical procedure. The instrument or implant must be returned to that vendor after use. (Infusion pumps, specialty beds, etc., were not addressed in this survey.) Below are the questions and the responses I received. Orthopedic loaner survey 1. Does your hospital use loaners for surgical procedures? 100 percent Yes 2. Does your hospital have a formal policy and procedure to follow concerning loaner instruments? 88 percent Yes; 12 percent No All of the No replies stated they are in the process of developing some kind of policy. 60 October 18, 2006

61 On borrowed time, cont d Please note that questions 3-7 are based on 23 responses the three hospitals without policies did not respond. 3. Do you feel the manufacture of the loaned items provided proper cleaning information? 87 percent Yes; 13 percent No 4. Do you feel the manufacturer of the loaned items provided proper sterilization information? 30 percent Yes; 70 percent No 5. Do you feel the items that are requested or loaned when received by your staff are clean and safe to handle by staff? 35 percent Yes; 65 percent No 6. Do you receive any documentation that the items are clean or what process they underwent to be cleaned by the company before they were received by your hospital? 4 percent Yes; 96 percent No 7. Is your hospital policy followed when items are requested and brought into your hospital? (Respondents were asked to indicate what percentage of the time the policy is followed.) 100 percent of the time: 22 percent percent of the time: 65 percent percent of the time: 9 percent Less than 60 percent of the time: 4 percent Respondents were asked to describe some of the situations where the hospital s policy was not followed. Responses included the following: Instruments came in too late. They just got the call to bring these items in for a case arrived less than 24 hours in advance. When items are brought into the hospital and go directly to the OR instead of CS. When the hospital is not involved event occurs between surgeon and the vendor. Weekends. Loaner items are not always available day before (in use someplace else). D e l i v e r e d / shipped to the OR directly. Surgeon talks directly to the manufacturer rep without communicating to Surgery or CPD that a loaner will be used on a specific case. The survey results support comments I have heard that loaners most often orthopedic are a concern for everyone in the hospital, not just central service. There is much confusion among surgeons, OR and CS staff, and equipment manufacturers regarding loaners. Part of the problem is a lack of information. In an effort to determine what information is available to hospitals regarding handling loaned surgical instrumentation, I conducted an Internet search on orthopedic instrument manufacturers. The responses I found indicated that manufacturers information stresses user/hospital responsibility with regard to loaners. (Manufacturers names withheld). For example: Hospital Responsibilities for Company X Loaner Sets: 1) Loaner sets should undergo all steps of decontamination, inspection, and terminal sterilization prior to their return to the sales representative. 2) Missing or damaged instruments from loaner sets should be brought to the attention of t h e operating room supervisor, to the director of the central supply department, and to the Company X representative to ensure that the next hospital will receive a complete set in workable condition. 61

62 On borrowed time, cont d Company X Representatives Responsibilities for Loaner Sets: 1) Ascertain that instrument sets are complete before delivery to, and following return from, the hospital. 2) Make sure that instruments are in good working condition. 3) Replace damaged or missing instruments and spare parts. 4) Take care that instruments are properly immobilized and protected during transit. 5) Inform hospital personnel that care instructions are available. Company Y states the following: Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material is suitable for use in sterilization processing and sterility maintenance. Regarding sterility, Company Y states: Users should conduct testing in the health care facility to assure that the conditions essential to sterilization can be achieved and that specific configuration of the container contents is acceptable for the sterilization process and for the requirements at the point of use. ANSI/ AAMI ST33: 1996 Guidelines for the Selection and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities covers the selection and use of reusable rigid sterilization container systems. Guidelines are provided for cleaning and decontamination, preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use. Company Z s loaners come with the following disclaimer statement: The instrument cases will allow sterilization of the contents to occur in a steam autoclave utilizing a cleaning, sterilization and drying cycle that has been validated by the user for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap to maintain sterility. A comment posted on the IAHC- SMM Forum regarding the condition of loaner instrument trays supplied by orthopedic companies stated: As for the ones that are used by the ortho companies... well, they work okay for the most part. The companies themselves don t seem to do a really good job of keeping them in good shape, the locks are missing on most and the inserts are usually in pretty bad shape. Almost unanimously, manufacturers state that it is the hospital s responsibility to make sure all items are clean and sterile. This then raises the question: Does the hospital verify all of the steps in its process when using loaners? The results of my surveys suggest that in many hospitals a lot of work needs to be done. There is a significant difference between what manufacturers and users think the manufacturer s role is. Standards and guidelines for loaners The majority of U.S. hospitals look to key sources when writing policies: AAMI, AORN, CDC, JCAHO, OSHA, NIOSH, IAHCSMM and ASHCSP. Although AORN and AAMI do not publish specific guidelines regarding loaned items, many AAMI documents contain sections that can be used when writing policies on loaners. Pertinent sections include: AAMI ST 35, which describes how items are to be transported and verifies the cleaning process; AAMI ST 77, which deals with containment devices to hold surgical instruments; and AAMI TIR12, which gives guidance on the information that a 62 October 18, 2006

63 On borrowed time, cont d manufacturer should provide to the user. AAMI guidelines also include references to the American Society for Testing and Materials (ASTM). ASTM International is one of the largest voluntary standards development organizations in the world a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy. ASTM standards include: F Standard Practice for Care and Handling of Orthopedic Implants and Instruments. F Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System, F Standard Test Method for Corrosion of Surgical Instruments, and D Standard Guide for Blood Cleaning Efficiency of Detergents and Washer-Disinfectors. Similarly, the AORN s 2006 Recommended Practices contain sections that deal with packaging and tray weight, but lack any specific document pertaining to loaners. Like AAMI, the AORN suggests that manufacturers instructions be followed as provided. ASHCSP s and IAHCSMM s joint position paper on loaners addresses many of the relevant concerns. The National Institute for Occupational Safety and Health (NIOSH) has published information on lifting and provides a formula for calculating two-handed lift tasks. Certainly the lifting of surgical trays would fall into this category. Although I ve focused on loaned surgical instruments (basically orthopedic) you cannot overlook that JCAHO requires hospitals to maintain a current inventory of all medical equipment, including rentals and loaned items. Hospitals are required to have a process in place for selecting and acquiring medical equipment. The hospital is responsible for all equipment in patient care areas. Thus, the issue of hospitals having policies regarding loaned surgical instruments falls under possible JCA- HO review. Issues regarding loaned surgical items are not unique to the United States; many countries are addressing these concerns. Canada s working standard Z is called Management of loaned, shared, and leased Medical Devices. In Switzerland, an article on how to manage loaned instruments can be found at Australia has addressed the topic of loaners from an ergonomic point of view. The findings are available at org.au/loan_sets/loan_sets.html. Hospital policies The snapshot survey revealed two concerns that instruments may not be clean upon arrival and that proper information on cleaning/sterilization is not provided. Consider the methods used to transport orthopedic loaners into a hospital. The manufacturer s sales representative usually transports the loaners via his or her car or van. The instruments are loaded into the vehicle, moved from hospital to hospital, and dragged from the parking lot into the department and directly into the OR. As an example, Charles Hughes, educator for SPSmedical, told attendees at a CS seminar in Detroit about a hospital in California that received orthopedic loaner trays with sand in the instrument cases. Interestingly, federal guidelines do cover the transportation of hazardous items. AAMI ST 35 states, The procedures for packing and transporting contaminated items off site for processing must comply with applicable U.S. Department of transportation (DOT) and state regulations the user is also responsible for processing the device according to the manufactures recommendations Studies have shown that surgical instruments are dirty. At meetings 63

64 On borrowed time, cont d I have heard many people express concern that the orthopedic instruments their hospitals receive appear dirty. If these orthopedic instruments are dirty, what is this dirt? Is it just something from the parking lot? If it is dried blood or some other form of bioburden, these instruments should be transported under the federal guidelines and follow OSHA regulations limiting occupational exposure to blood-borne pathogens. (29CFR along with following Title 49, parts 170 through 178 of DOT guidelines). In light of these comments and findings, every hospital needs to ask, What are we going to do to make sure the loaner instruments we receive are safe upon arrival for our staff to handle and process, as well as to prepare them for proper patient use? What do we do about instruments that are brought directly from another hospital and delivered to the Operating Room? If we did not clean them, then how do we know and document that simply flash sterilizing them will render them sterile? Sample hospital policies The survey results indicated that some hospitals do have policies regarding loaners. The following excerpts are taken from actual policies: When there is no Inventory Count Sheet available or no Vendor Representative present to inventory the set, write on the Loaner Instrument Received form, no inventory sheet available; not responsible for incorrect inventory upon return. Loaner instrumentation and implants that are left in the delivery area after the procedure are not the responsibility of the Medical Center. SPD staff has been instructed not to sign contracts accepting responsibility for trays of loaner instruments, equipment, or implants. All Loaner instrumentation and/or any other items needing sterilization should be accompanied with sterilization instructions, preferably on company letterhead. All Loaner instruments will be washed prior to set-up when they are brought in from outside the facility.if the information is lacking, the instruments will not be accepted. Trays should be clearly labeled in order to assist the SPD staff in labeling the tray properly. The vendor representative will deliver the loaner instrument trays or sets, the completed Sales Rep/Loaner Tray Form, the SPM labels, and the cleaning and sterilization instructions to Central Sterilizing Services (CSS) decontamination area this must be done before 7 PM of the day before the scheduled date of the case.. The Borrow/Loan Coordinator is responsible for taking all requests for the borrowing or loaning of supplies, equipment and instruments within our hospitals as well as those facilities outside that are approved participants. The Borrow Loan Coordinator completes tasks relative to the borrow loan process, including, but not limited to, physical check in and check out documentation process for borrow/loan receiving, vendor and courier pick-ups, preparation and packaging for sterilization. Checks all incoming instrument trays for completeness, according to count sheet provided by vendor, or in conjunction with vendor. Some hospitals use dry-erase board and shift reports to communicate and coordinating task of loaner instruments. Central Service departments are known for their creativity. Mike Murphy at the University of IOWA describes calling a surgeon at home about a set of loaners that would not be ready for surgery the next day: I have discovered that it really does not take much to call a surgeon at home. He would much prefer to be called there and asked a question than to come in, the day of surgery and have things be a mess. They are never happy to receive such a call but in this way it is a proactive action rather than reactive and this helps make us a part of surgery rather than being seen as the problem. Teamwork and support can move mountains and positively affect a change for the better. 64 October 18, 2006

65 On borrowed time, cont d Dollars and sense Currently, orthopedics constitutes a $12-billion market, and that market is poised for exponential growth. This is exciting, yet concerning, for manufacturers at every level. Approximately 20 percent of all surgeries require loaner kits. This inefficient program costs some of the largest manufacturers more than $50 million a year, with leading OEMs shipping more than 100,000 kits annually. Shipping alone can cost as much as $150 per round trip, while internal hourly labor rates of $80 or more can become untenable. One manufacturer assesses hospitals a fee if the loaned items are returned dirty. Its loaner policy states, This surgical instrumentation system is a loaner set. To ensure optimum sterility, your hospital is responsible for checking and cleaning this system prior to sterilizing and when returning to X Company. This surgical instrumentation system contains several cannulated instruments, which require special attention when cleaning. IMPORTANT: A $50 fee will be added to your invoice if the system is returned to X Company in an unacceptable condition. Loaners do affect a manufacturer s bottom line, as indicated in this passage from a company s annual report: The Company anticipates investing in future business growth, including business and product line acquisitions to supplement its current product offerings, loaner instrumentation for surgical implants in support of new product launches and future building expansions, including manufacturing facility expansions for certain divisions. increased meeting costs and higher amortization expense associated with loaner instrument sets. Manufacturers are beginning to listen to their customers. An article that recently appeared in an orthopedic trade publication stated, Manufactures are also paying attention to how much instruments weigh. a lighter weight also can appeal to the individuals who must carry entire instruments sets into the operating room... it s obviously easier for them to lift an 18lb set versus one that s 30 lbs. Instrument manufacturers certainly have a stake in solving the user concerns regarding loaners. Manufacturers are also concerned about receiving dirty products back and with the cost associated with loaners in general. Where do we go from here? We have examined manufacturers guidelines, professional organization standards, national standards and practices (both here and abroad), current hospital policies, current research, and anecdotal stories. The solution requires all those involved surgeons, instrument manufacturers, and hospital staff from biomedical engineering, central service, and the operating room to sit down and work together. The various professional groups such as IAHCSMM, ASHCSP, AORN, APIC and AAMI also need to be part of this solution. The time to address the issue is now; frustration has reached a maximum level. Central to any discussions should be the following statement, which I paraphrase: The primary responsibility of any hospital employee is to protect patients from harm. By facilitating best practices in whatever they do, so they can minimize patients risks associated with infection while in the hospital. The practice of loaning items requires that we implement the best practices to ensure clean and sterile instruments on both sides of the transaction. Implementing our best practice will allow us not only to protect staff but also to provide a better quality product for patients. (Note: The author understands that hospitals do not only receive surgical (orthopedic) instruments as loaned items; loaner items can be anything from flexible scopes to specialty beds to infusion pumps. Thus, any policy should address all medical devices that are loaned, leased, borrowed, shared or rented by a hospital. The author also thanks all the hospitals that filled out the survey and shared their thoughts on loaners. 65

66 Make Clean Seen 66 October 18, 2006