Improving the Performance of Your Medical Automatic Washer

Transcription

1 Improving the Performance of Your Medical Automatic Washer by Stephen M. Kovach, BS, CSPDT Objectives After completion of this self-study activity, the learner will be able to: 1. Discuss the variables that influence the automatic washing process. 2. Design a quality improvement program for a medical automatic washer. 3. Describe the various guidelines and recommendations concerning monitoring the automatic washing process. 4. List the differences between various types of medical automatic washers. Test Questions True or False 1. Blood cells colored with hemoglobin are fairly easy to wash off instruments; clear fibrin material is much more difficult to remove. 2. Moist alkaline detergents dissolve dry proteins and cause fibrin to break, mimicking enzyme action. Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded one and one-half (1.5) contact points for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one and one-half (1.5) contact hours for a period of five (5) years from the date of publication, and to be used only once in a recertification period. This inservice is 3M Health Care Provider approved by the California Board of R e g i s t e red Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 103. Managing Infection Control and 3M Health C a re will be working collaboratively to pro v i d e continuing education courses in monthly editions of Managing Infection Control. 3. In general, the harder the water, the more cleaning solution will be needed in the cleaning process. 4. American Society of Testing and Manufacturing (ASTM) has recently established a new standard D7225 Guide for Blood Cleaning Efficiency of Detergents and Washer Disinfectors. 5. Association for the Advancement of Medical Instrumentation (AAMI) and Joint Commission for Accreditation of Healthcare Facilities (JCAHO) support implementation of Quality Improvement Processes in the Sterile Processing department. 6. Cleaning is the removal of all visible dust, soil, other foreign material and some microorganisms. 7. A solution with a ph of 9 is an acidic solution. 8. Following the manufacturer s instructions is not important in the cleaning process. 9. The prewash cycle temperature should be colder than 113 degrees Celcius. 10. Staff should have at least yearly training on the operation of the automatic washing equipment. Introduction The reliability of sterilization is affected negatively by the number, type, and inherent resistance of microorganisms, including biofilms, on the items to be sterilized. Soils, oils, and other materials may shield items from contact with the sterilant or combine with and inactivate the sterilant. 1 Providing a properly assembled sterile instrument to the operating room is paramount to the success of any surgical procedure. Doing so is not an easy task, however. Hospitals that implement a Quality Improvement Program for their medical automatic washer help ensure that patients enjoy the best possible outcome of surgery. One only has to think of the circle of life from the movie The Lion King to begin to understand the complex process of providing a properly assembled sterile instrument to the OR (see Figure 1 on page 79). Providing instruments sterile and ready for use requires many steps. Each step depends on successful completion of the previous step. For example, a hospital can clean and sterilize items properly; but if instruments are transported improperly, the effort made to sterilize them is wasted (see Figure 2 on page 79). 78 MANAGING INFECTION CONTROL

2 Figure 1. Automatic cleaning is part of the circle of life in sterile processing. A properly functioning medical automatic washer is vital to the process of providing a clean item for staff to assemble and prepare for sterilization, and eventually use on a patient. Staff must understand the variables that affect the medical automatic washer s performance and must monitor and correct any deviations from the washer s target parameters in order to assure that the process works. Note: The author realizes that much is being done within the global community with regard to verifying the effectiveness of medical automatic washers. This article deals with practices within the United States only. It does not address flexible automatic scope washers (automatic endoscope reprocessors), only washers intended for cleaning surgical instruments. Figure 2. Improper transportation of item under the arm. Cleaning is one of the first steps to providing a workable and sterile instrument to the operating room. Cleaning has three major objectives: Remove visible soil. Remove invisible soil. Remove as many harmful microorganisms as possible. Manual or mechanical processes or a combination of the two can be used to achieve these objectives. Cleaning involves many steps, each of which influences the outcome. This article will focus on the medical automatic washer and the variables that influence its effectiveness. What is a medical washer/disinfector? What does it do? A medical washer or washer-disinfector is a medical device intended to process medical devices. The FDA regulates the introduction of medical devices in interstate commerce. A medical washer-disinfector intended to clean and provide high level disinfection of medical devices must have a FDA cleared pre-market notification [510(k)] submission before it can be sold. A medical washer intended to clean medical devices or a medical washerdisinfector intended to clean and provide either low or intermediate level disinfection of medical devices is exempt from 510(k) requirements. 2 The majority of medical automatic washers used in U.S. hospitals today deliver low- to intermediatelevel disinfection and are exempt from the 510(k) submission requirements. Medical automatic washers (also known as washerdecontaminators, washer/disinfectors or automatic instrument washers) initially developed from commercial dishwasher technology and have adapted to today s science-based requirements. Maybe this is the reason that, even today, many institutions regard the medical automatic washer as nothing more than a dishwasher, when in fact it is one of the most vital pieces of equipment in the fight to reduce healthcare-acquired infections. The simple definition of a medical automatic washer is a piece of equipment that cleans and decontaminates dirty surgical instruments so they can be handled safely, repackaged and sterilized for a future procedure. Some medical automatic washers can process only bedpans, while others can process a variety of items, including s u rgical instruments with and without lumens. Some washer manufacturers offer racks specially designed for lumen-type and minimally invasive surgery instruments (see Figure 3 on page 80 ). MANAGING INFECTION CONTROL 79

3 Figure 3. Special rack for lumen items. Figure 4. Batch washer basic design (coupler system can be located on the side wall in some models). Medical automatic washers fall into two distinct categories of operation. In North America, machines rely on high impingement and softer chemistry; in Europe, machines rely on low impingement, high water volume, and more aggressive chemistry. There are two basic types of medical automatic washers: 1. Batch-type: This washer has a closed cabinet that is linked to the water supply and drainage system. The machine is loaded with the soiled instruments/utensils, and the doors are locked before the cycle commences. All stages are performed in one chamber (see Figure 4 right). 2. Indexed/rack conveyor washers (tunnel washers): This type operates as a continuous-feed system in which soiled instruments are loaded on one end and reprocessed instruments are ejected on the other. Soiled instruments/utensils are transported from chamber to chamber in which different stages of the process are performed (i.e., rinse-wash-disinfect-dry) (see Figure 5 Tunnel washer below). Regardless of the model or the theory behind a medical automatic washer, if it is maintained (preventative maintenance by a qualified person), properly calibrated, variables monitored, and used accordingly, it is capable of effective cleaning. Figure 5. Basic tunnel washer. 80 MANAGING INFECTION CONTROL

4 Variables that impact cleaning A w a s h e r s effectiveness depends on several variables that are equally important in achieving the desired result clean instruments that are safe to handle and then sterilize. These variables include: Target soil type of soil to be cleaned; Instrument design item to be cleaned; Water quality (e.g., hardness, ph); Temperature and time; Chemical activity the ability of the cleaning solution to hydrolyze target soils; Mechanical action the energy needed to clean (agitation); Human variables and intangibles (e.g., staff training, loading methods). The final variable is active monitoring of these input parameters and of the final outcome: instrument cleanliness. This can only be done via a quality improvement program in which a Sterile Processing department maintains and improves the medical automatic washing process (following the equipment manufacturer s instructions) and its staff understands the variables and how they interact. A good quality improvement program should be based on these variables. Let us examine them individually. Target soil 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-to-clean locations. It then coagulates and dries to create a significant challenge to cleaning. 4 Blood is the soil most often found on surgical instruments. Thus it is blood that is the residual soil one most often looks for when making sure items are clean. Dried blood on instruments is hazardous to the employees of the hospital and to the next surgical patient upon which the instruments are used. T h e danger of handling instruments contaminated with blood is obvious in this age of hepatitis 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. Cleaning dried blood is much more difficult than cleaning other soils. Blood coagulates, which means it goes from a free-flowing liquid to a solid that contains tough, microscopic fibers called fibrin. Fibrin is formed as the blood coagulates. The fibers 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. Hemoglobin (the red-colored cells of blood), when wet, is fairly easy to wash off instruments. However, should hemoglobin dry it becomes highly insoluble and very difficult to clean. Removing blood from a surgical instrument can be difficult. Ensuring that no residual blood remains after cleaning is critical to the sterilization process. Instrument design The complexity of an instrument s design is directly proportional to the complexity of cleaning it and the difficulty of verifying cleanliness. MANAGING INFECTION CONTROL 81

5 Twenty years ago surgical instruments were simpler in design. Today we have: Long narrow lumens; Tiny serrations; Multiple parts; Higher quality stainless steel; Various metals and plastics. But even traditional instruments pose a challenge. One of the most challenging areas to clean is an instrument box lock (see Figure 6 below). This tiny narrow area is often found with dried blood inside. The dried blood not only damages the instrument itself but also is a place where microorg a n i s m s hide and are protected during the sterilization process. The cannulated areas of instruments also can harbor hard-toclean blood. After surgery box locks should be opened and instruments with removable parts should be disassembled. This will limit drying of blood on instruments, which may cause corrosion. 5 binding with the target soil. Dissolved solids in water present obstacles to good cleaning. Hardness minerals can also 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 cleaning solution will need to be. Water hardness thus can diminish product efficacy and efficiency. Routine monitoring of water hardness helps to ensure the optimum performance of equipment and cleaning solutions (see Figure 7 below). Figure 7. Water hardness chart. ph The ph level indicates the acidity or alkalinity of water on a scale from 0 to 14. A solution is considered neutral if it has a ph-level of 7. One to 6 on the scale is considered acidic; 8 to 14 on the scale is called alkaline or a base. Improper ph can compromise the effectiveness of cleaning solutions. Knowing the water s ph helps ensure optimum performance of the cleaning solution. Figure 6. Box locks. Water quality Water as a variable in the cleaning process is sometimes underappreciated. Failure to recognize poor quality water, failure to treat water as needed, or failure to monitor and take action on poor water quality places patients at risk. The relevant measurable characteristics of water in the cleaning process are hardness, ph-level, temperature and purity (microbial contamination). Hardness Hardness is usually 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, preventing them from Temperature and time These two parameters are interdependent at almost every stage of the automatic washer process. A low temperature at the start (to prevent denaturing) and higher temperature later (to maximize enzymatic solution or d e t e rgent) are crucial for thorough instrument cleaning. Monitoring the temperature at all stages of the process is important because improper temperature can cause adverse reaction and poor performance. Water temperature is the key to thermal disinfection in a medical automatic washer. The level of disinfection d i ffers between brands of medical washers, as does the time and temperature required to achieve the specified disinfection level. One must remember that the target of thermal disinfection is the surface of the instrument. Thus, it is key to monitor the surface temperature of instruments to know whether disinfection has occurred. Water temperature 82 MANAGING INFECTION CONTROL

6 needs to be monitored and documented independently of the machine for two reasons: 1. Washers only monitor the temperature of water in the sump, not at the instrument surface level. 2. Thermal couplers and heaters can fail. With enough time, simple water will remove all types of blood and other soils (the Grand Canyon is evidence of this). Of course, surgical services do not operate on geologic time scales more like supersonic. As a result chemical solvents (e.g., enzymes, soaps) are required to speed the hydrolysis of target soils. The contact time for the various cleaning solutions needs to be optimized so they can work as intended. Cleaning solutions should be applied for at least the minimum time specified on the product label. More contact time between the cleaning solution and the target soil might be needed to completely clean some instruments. Decontamination holding time (DHT) DHT is the duration of time between an instrument s last surgical use and the moment the cleaning process begins. DHT can vary in length from just a few minutes to hours or even days. The longer the time before the cleaning process begins, the greater chance instruments will arrive for assembly dirty on the clean side. Thus, it is important to keep soiled instruments moist after use. This can be done by placing a wet towel over the instruments or by using one of the many sprays now available to keep instruments moist. Sterile Processing staff should remind their colleagues in the Operating Room of the importance of wiping down instruments during surgery and sending them back to the decontamination area in the best condition possible (see Figure 8 below). Figure 8. Decontamination area with supplies coming back from the Operating Room. Chemical activity cleaning solutions The two types of cleaning solutions normally used in medical automatic washers are enzymes and detergents. Studies have demonstrated clear differences between cleaning agents. 6 Enzymes are biological agents that break down t a rget soils, making them more soluble through a process called hydrolysis. Time is needed for this action to take place. The time needed to act depends on factors such as concentration, temperature, ph, and the type and amount of soil to be removed. Four basic types of enzymes are used to clean surgical instruments: Lipase breaks down fats and greases; Protease breaks down protein; Cellulase breaks down cellulosic materials such as wood, cotton and paper; Amylase breaks down carbohydrates and starches. D e t e rge nts are chemicals that reduce surface tension during cleaning so that water can spread and wet surfaces. These chemicals are also called surfaceactive agents, or surfactants. Surfactants perform other important functions in cleaning, such as loosening, emulsifying (dispersing in water), and holding soil in suspension until it can be rinsed away. Similar to protease enzymes, high alkaline surfactants hydrolyze proteinaceous soils. 7 Foaming is also a factor; low-foaming detergents are preferable for medical automatic washers. Note: Remember no two enzymes or detergents are exactly alike. Knowing the difference between them and what they can do gives the Central Sterile Processing p rofessional a better understanding of the cleaning process and his/her particular needs. The effectiveness of any cleaning solution depends on certain factors, including dosing, concentration, storage conditions, age, decontamination room environment and adherence to label instructions. According to Martin We i d e r, a major washer concern is the dosage and control mechanisms for dispensing cleaning solutions. 18 These variables should be validated and monitored because they are a significant cause of poorly cleaned instruments. Blocked or kinked feed tubing may limit the amount of chemicals being pumped into the washer. Broken pumps, incorrect temperature, misaligned coupling mechanisms and compromised spinner arms, all play a role in delivering the proper dosage of chemical agents. The length of the tubing from the source (cleaning solution) to the pump is also important. Inherently, pumps are capable of delivering solution at a maximum distance. Sterile Processing staff should know the maximum length of tube their machine s pump is designed to work with (see Figure 9 on page 86). 84 MANAGING INFECTION CONTROL

7 Figure 9. Examples of poor administration of cleaning solution. Air in line. Users should be aware that, although most washers are designed to alarm when the volume of cleaning solution in the storage barrel is low, most washers will not warn when detergent is not being delivered. For instance, a washer will continue to run even if it is pumping only air. It is important to ensure that the dosage pump is properly functioning and calibrated. A simple way to monitor the pump is to mark the barrel of solution daily (see Figure 10 left). Each cleaning solution has a minimum concentration for potency. The ratio between the target soil (contaminant) and the applied cleaning solution is important. Follow label requirements for concentration levels; they vary according to the water quality and amount of target soil present. Cleaning solutions should always be stored according to the manufacturer s directions. Some cleaning solutions (particularly enzymes) can be deactivated by heat, so it is important to store and transport them at the proper temperature (see Figure 11). Likewise, relative humidity of the decontamination room can affect the solution s penetration, so the room s relative humidity should be monitored and documented. This can be done with simple wall monitors or electronic devices that can store the data for later retrieval. Temperature and humidity levels should be documented at least every shift. Figure 11. Temperature on the barrel. Figure 10. Barrel marked. Cleaning solutions that have passed the manufacturer s usage date will not clean as validated by the manufacturer. Staff should know their solutions expiration dates and be sure to rotate product. Always follow the manufacturer s guidelines and label instructions. No two products or pieces of equipment are the same, and instructions can vary: Do not use on anodized aluminum automatically feed at 1/4 to 2 fluid ounces per gallon of water depending on soil load and water conditions MANAGING INFECTION CONTROL

8 May be used in manual or ultrasonic/automated cleaning systems... Do Not use for cleaning spinal syringes or needles works in all water temperatures 10 Central service staff should understand how each piece of equipment works, which cleaning solutions are best for their equipment, and the limitations of those solutions. Choosing the wrong cleaning solution can cause problems down the line. S t a ff should read all labels and product safety information (e.g., Material Safety Data Sheets [MSDS]), as well as any white papers the company provides for its product. A file on each product should be located in the department for easy reference. The more information available, the better prepared the staff. Mechanical action The mechanical efficiency of a washer is vitally important to performance. Each washer has its own cycle setting (prewash, rinse, enzymatic/detergent, sonic, disinfection, drying), which must be matched with the cleaning solution and the instruments to be cleaned (general instrument, micro, orthopedic). Other important variables include the length of the cycle, agitation, instrument loading, tray and rack selection, rinsing and staff training regarding proper use of the machine. Agitation Physical agitation from water spray brings fresh cleaning solution to the soiled area and washes away used detergent. Spray impulses loosen blood through physical impact. Spray from different angles helps prevent blocking from instruments piled on top of one another. Instruments must not be stacked or overloaded in any tray. Evenly spreading instruments within the tray provides optimum exposure to the cleaning solution and spray action. Stringing instruments is an excellent way to expose all the areas of an instrument to the cleaning action of a medical automatic washer (a five-inch stringer will keep instruments open and exposed) (see Figure 12). A blocked spray nozzle decreases cleaning power. If two holes are blocked on a 10-hole spray arm, the spray is only 80 percent efficient. Such a blockage affects not only the cleaning power but also the effective rinsing of the cleaning solutions. Verifying that spray arms achieve full rotation and that the nozzles are clean will help ensure effective cleaning action (see Figure 13 below). Figure 13. Spray arm concerns. Yuck! Two holes blocked. Figure 12. Stringing instruments. Side holes blocked. Loading If instruments are not loaded properly they will not come clean, even in a properly performing washer. Thus, staff must know proper loading techniques (see Figure 14 on page 89). 88 MANAGING INFECTION CONTROL

9 One washer manufacturer s guide to operation includes the following instructions for loading instruments: Open all instruments, especially clamps; keep spray arms free from obstructions; keep instruments in a basket; avoid overloading a basket; do not allow items to protrude outside of the rack. Wire mesh baskets are better than perforated trays. Avoid solid side trays or trays with limited perforations on the bottom. 11 Figure 14. Improperly loaded instruments How clean do you think these instruments will be when they come out of the medical automated washer regardless of how well the washer is performing? MANAGING INFECTION CONTROL 89

10 When loading the washer, staff must separate multilayer trays so that cleaning solutions can have direct contact with the instruments. The Sterile Processing staff should also follow these rules for loading an automatic washer: Open hinged instruments and place on stringer if possible (at least 5 inches). Disassemble sets and instruments according to manufacturer s instructions. Place concave instruments on their side or upside down. Use specialty baskets/trays when available (e.g., basins). Separate stainless-steel instruments from other metals. To avoid electrolysis, place different metals in their own tray/basket if possible. Put the heaviest instruments at bottom of the basket. Do not place them on top of delicate instruments (see Figure 15 below). Figure 15. Properly loaded trays (5-inch stringer). Notice how wide the instruments are open to get maximum exposure to the cleaning process. Tray and rack selection Trays for washing can be different than trays for sterilization. It is important to pick and use the correct type of tray in order to optimize cleaning results. In his paper And then there was Decontam, a paper authored by Richard Schule, Director, Clinical Sterile Processes at Clarian Health, he notes that loading racks have variations and should be numbered. If a problem arises, staff can track back to a specific rack for follow up. 1 9 Metal racks are subjected to strenuous conditions that can cause them to warp and break down. Couplings may show fatigue; spray arm bushings may break and fail. Such failures indicate that the correct water pressure (cleaning power force) is not being delivered. Rinsing Thorough rinsing is needed at various stages of the washing cycle. The quality of the rinse may differ from stage to stage. Rinsing between stages prevents residuals from being transmitted from one stage to the next. The final rinse after cleaning is extremely important because any residuals after this stage will likely remain on the instrument and could detrimentally affect disinfection and sterilization, and/or cause adverse reactions in the patient. Some medical automatic washers are programmed with only 15 seconds of rinse time. Sterile Processing staff should verify that the rinse time is long enough to remove all residue. Quality of the rinse water should be monitored as well. Biofilm Biofilms are a concern with medical automatic washers. Biofilms are produced by microorganisms and consist of a sticky rigid structure of organic contaminates. A slime layer anchors firmly to a surface and provides a protective environment for microorganisms to grow. The chamber walls inside medical automatic washers are an area that staff should check routinely for any biofilm build up. Some companies recommend using a de-scaler to clean the chamber walls on a routine basis. Poor water quality, poor rinsing and too much cleaning solution are possible reasons for a build up of biofilm inside the medical automatic washer (see Figure 16 on page 91). Washer features When purchasing a washer, staff should know which optional features are most important. For example, a washer with a window allows the user to view what is going on inside the chamber. Staff should MANAGING INFECTION CONTROL

11 Figure 16. Biofilm example. Yellow film on wall. White and red film on wall. MANAGING INFECTION CONTROL 91

12 be able to print out the cycle parameters for each machine. If more than one machine is in use, each should have its own alarm system for detecting low levels of each cleaning solution. Features such as a window and an alarm help staff identify and solve problems in the automatic washer cleaning process. Always follow the manufacturer s guidelines for replacement of parts and service. Factory-trained technicians should perform replacement and servicing of the equipment. For example, temperature variations in a washer can be caused by a faulty thermostat or heating element. The dosage pump must be calibrated regularly to ensure delivery of the correct amount of cleaning solution. Review the preventative maintenance manual with the repair technician. Involving the hospital s biomedical department in this review can help ensure that the proper work is being done. Staff training The most critical component in any cleaning process is the human one. The staff working in the decontamination area must understand the importance of their work and how they affect not only patient health and safety, but also that of themselves and their fellow staff. Regular, professional staff training will help ensure that instruments are clean. Training should include, but not be limited to, cleaning solutions, equipment and personal protective apparel. Training should be mandatory for new employees, and conducted annually for all s t a ff. A certified Sterile Process staff only enhances the outcome of the facility s cleaning process. Certification ensures a level of understanding of the cleaning process that is continually updated and enhanced through recertification. It takes time and dedication to keep the medical automatic washer functioning properly. Running instruments through a washer does not guarantee that they will be fully cleaned; all of the variables mentioned in this article must be working at their optimum for the process to be complete and for staff to have confidence in their equipment. A quality improvement program takes time to implement but will prevent future headaches, such as additional manual cleaning and reduced s t a ff productivity. It allows staff to better understand the cleaning process and to solve problems more easily when they do occur. The importance of monitoring Testing a medical automatic washer to ensure it is properly calibrated is vital to any hospital s infection control program. Washers fail to clean for many reasons. Independent testing provides a means of monitoring the variables that influence the effectiveness of an automatic washer. Professional o rganizations and government agencies including JCAHO, FDA, AORN, IAHCSMM, ASHCSP, ASTM, CDC and AAMI, as well as equipment manufacturers, recommend that Sterile Processing departments have a quality improvement program in place to reduce the incidence of dirty instruments resulting from a poorly functioning washer. The following statements from professional organizations support implementation of quality improvement programs: J C A H O Standard E.C.6.20: Medical equipment is maintained, tested and inspected. (2005) A A M I ST79:2006, Verification of the cleaning process:. processing personnel are increasingly aware of the need to control and standardize the steps taken to ensure the sterility of devices for patient use. Because disinfection and sterilization cannot be assured unless the cleaning process is successful, professionals in the field ought to seek out whatever means are available and practical to verify this function. A quality system would call for monitoring and documenting decontamination processing parameters, whether the process is accomplished by hand or mechanically. AAMI ST79:2006, Annex D User verification of cleaning processes: Ideally, cleaning verification by users should include visual inspection combined with other verification methods that allow the assessment of both external surfaces and inner housing and channels of medical devices. Manufacturers should strive to provide users with such tests so that medical devices can be tested directly after cleaning in a way that will not damage the device or require recleaning I A H C S M M s Central Service Technician Manual 6th (2003) edition contains a section on ways to verify the cleaning process. AAMI TIR12:2004 defines verification and validation for the user and the manufacturer: user verification: Documented procedures, performed in the user environment, for obtaining, recording and interpreting the results required to establish that predetermined specifications have been met validation: Documented procedures for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications. The Getinge Company offers a performance monitoring program that allows users to independently verify the key 92 MANAGING INFECTION CONTROL

13 variables of the medical automatic washing process. This is exactly what AAMI TIR12:2004 calls for: that companies provide a way to verify their equipment is working properly. Ideally, when the washer is serviced a test object is used to verify the machine is operating at the same level as when it was originally installed. The user has proof the equipment is working properly and has been independently verified. At this writing Getinge is the only company of which the author is aware that is providing this service as part of its documented service program. Setting up a quality improvement program Proper cleaning then is very critical to the sterilization process. A quality improvement program with an independent, objective test for the variables that affect the automatic cleaning process allows the Sterile Processing professional to monitor and ensure that proper cleaning is being done. Because no two Sterile Processing departments have the same cleaning process, the quality improvement program outlined below is necessarily generic, but does include many of the variables mentioned earlier in this article. The program assumes the following: Appropriate facilities are provided; Appropriate equipment is used; Equipment is fit for its purpose, properly maintained and calibrated, and properly monitored and validated; Staff are properly trained and supervised; Single use medical devices are not reused; Records of decontamination are kept. 12 A quality improvement program should be based on staff observations and on data obtained by monitoring the key variables. The process should be ongoing; tests can be conducted each shift, weekly, monthly, quarterly or yearly depending on the variable monitored. Water quality testing Water quality in a hospital can change from when it enters the building to when it is used. Water can be easily monitored by using a dipstick test. Staff should monitor and document at least the basic parameters (ph, hardness, MANAGING INFECTION CONTROL 93

14 alkalinity) at least weekly. Documenting the results over time allows staff to discern trends. When trouble arises staff can use this data to help solve the problem. Many cleaning solution manufacturers will provide a free water-quality analysis. Sterile Processing staff can also ask the hospital maintenance department for the records they keep on the quality of water entering the hospital. Temperature monitoring Proper temperature at the various stages of cleaning is vital to the successful function of an automatic washer. Water temperatures must not exceed certain levels at certain cleaning stages. Temperatures at the various stages should be monitored and documented at least weekly. A simple irreversible thermometer can be used to verify and document the highest temperature reached during a cycle or stage of a process. Alternatively, a temperature data logger can be used to record and store the full temperature profile of an automatic washer cleaning cycle. The data can then be downloaded and stored for future reference. Either way, recording and documenting the data is key to ensuring the washer runs at the correct temperature for each cycle or stage of the process. Instrument and target soil testing As stated previously, blood is the primary target soil for the medical automatic washer. 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 13, and the TOSI 14, a prepared test object. The Edinburgh soil is made up in the department by s t a ff. 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 medical automatic washer using a normal loading pattern. A visual inspection of the instruments is required after the washing process is complete. Results are recorded and interpreted according to the soil manufacturer s guidel i n e s. The TOSI (Test Object Surgical Instruments) (see Figure 17 below) has three components: the blood soil, a stainless steel plate and a clear plastic holder. The soil is comprised of blood components that have been mixed and applied in a precise manufacturing process. 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. This mimics a box lock of a surgical instrument (see Figure 6). The TOSI is made in a quality-controlled environment (International Standards Organization [ISO] certified facility), ensuring consistency among individual tests. During the test, one TOSI is placed inside an empty tray/ basket for one complete cycle. In some washers, one TOSI test goes on each level. Users should follow manuf a c t u r e r s instructions and refer to the troubleshooting guide in case of unsatisfactory results. Results of the test are recorded, and problems are addressed. The result of a TOSI test help staff to diagnose problems and address the root cause(s). The American Society of Testing and Manufacturing recently established a new standard D7225 Guide for Blood Cleaning Efficiency of Detergents and Wa s h e r Disinfectors. The design of the TOSI complies with D7225, providing the user with the means to implement this method. Following D7225, the user performs a qualitative evaluation of the cleaning efficiency of their medical automatic washer. Hospitals and equipment manufacturers can use available test methods to help Figure 17. Blood soil tests TOSI and LumCheck. 94 MANAGING INFECTION CONTROL

15 ensure that medical automatic washers are performing p r o p e r l y, thereby reducing healthcare - a c q u i red infections that result from using dirty instruments. Testing for hollow/lumen instruments Many of today s advanced medical automatic washers have the ability to irrigate hollow instruments, allowing the Sterile Processing 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. 1 5 A new test, the LumCheck 15 (see Figure 17) can be used to evaluate the cleaning performance of washers that irrigate 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 LumCheck. Report any concerns to the appropriate management staff for follow-up. Sonic testing Some medical automatic washers have a sonic cycle. This cycle can be monitored using any of three methods: a foil test, a sonic probe test or a SonoCheck. The sonic probe test and the foil test are somewhat difficult to perform in a washer s sonic chamber. The SonoCheck is easy to use and read. Proper use of the SonoCheck was discussed in the article Improving the Quality of the Sonic Cleaning Process, which appeared in the July 2006 issue of Managing Infection Control. Picking the right test The Sterile Processing staff must determine the best test method for their particular facility. Some tests are subjec- MANAGING INFECTION CONTROL 95

16 tive in nature, and consistency (repeatability) is a concern. Criteria for test selection should include: Ease of use and interpretation of results; Consistency of application of the test; Availability and cost; Correlation of test soil with the actual target soil(s); Reliability and reproducibility of the test results; Ability of test results to indicate the source of problem(s); Scientific data supporting use of the test. Training Proper staff training is vital to the process. Document all in-services, and have competencies for the various activities performed. Equipment maintenance After any maintenance is done on the washer, 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 any necessary adjustments can be made immediately. Summary Simply running a test through the automatic water is not enough to ensure that the process is working properly. T h e Sterile Processing department should implement a quality improvement program for the washer that includes: Measuring ph and water hardness; Monitoring the temperature of the water at various stages; Performing a target soil cleaning test; Performing 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; continued on page 102 Figure 18. Working with your Automated Washer Work Flow (Duties) 96 MANAGING INFECTION CONTROL

17 Figure 19. Sample quality improvement program form. MANAGING INFECTION CONTROL 97

18 continued from page 96 Training of staff on a continuous basis; Degassing procedure if the washer has a sonic cycle; Proper loading of instruments; Appropriate tray selection; Other key factors/inputs relevant to each hospital s process; Recording all test results and observations in a log/book; Referring to the equipment manufacturer s troubleshooting guide in case of unsatisfactory results. 16 Figure 18 illustrates a sample flow diagram for a quality improvement program in a hospital Sterile Processing department. Figure 19 (page 97) is an example of a quality improvement program checklist provided by Healthmark Industries. The Sterile Processing management team is ultimately responsible for providing clean, properly functioning sterile instruments. Part of that process in the majority of hospitals is making sure the medical automatic washer is working properly. Issues concerning the operation of a medical automatic washer and the cleaning process in general, and results of monitoring should be reported routinely to the infection control committee and to risk management. Incorporating these reports as part of a monthly quality management meeting is an effective way to achieve and document this type of c o m m u n i c a t i o n. Audits of practice (e.g., observations, random conversations with staff at work) will help ensure that all staff are following policy and procedure and can identify situations where changes might need to be made. A quality improvement program will assure compliance with regulations and will help to prevent the incidence of unclean, unsterile instruments. Closing Comments R e m e m b e r, the first goal and focus of any healthcare facility is to do no harm. Delivering the highest quality of care possible is a key element in achieving that goal. Residual of any type (detergent, blood, protein, etc.) on any instrument can cause harm. The author realizes that there is much research and debate concerning the level of detection necessary. However, failure to monitor the cleaning process or to implement a quality improvement program to provide better patient outcomes is counter to the concept of to do no harm. The following quotes from two of the best sources on the subject sum up why a hospital/clinic should monitor the medical automatic washer cleaning process: AAMI ST79:2006 states, Sterile processing personnel are increasingly aware of the need to control and standardize the steps taken to ensure the sterility of devices for patient use. Because disinfection and sterilization cannot be assured unless the cleaning process is successful, professionals in the field ought to seek out whatever means are available and practical to verify this function. A quality system would call for monitoring and documenting decontamination processing parameters, whether the process is accomplished by hand or mechanically. JCAHO s (2005) standard E.C.6.20 says, Medical equipment is maintained, tested and inspected. An ineffective automatic washer compromises sterilization and places both employee and patient at risk. Improperly cleaned items can result in patient infections, delayed cases (need to re-set up room) and even death! 14 A hospital that does not have a quality improvement program (see Figure 20) in place for the washer risks not meeting the fundamental goal of to do no harm. Regular testing of the key variables just makes Common Sense for Sterile Processing. Figure 20. Quality improvement program cycle. References 1. AORN Journal. Recommended Practices for Sterilization in the Perioperative Practice Settings. March: Rudin, D. Efficacy Against Infection Prions in Instrument Reprocessing. Infection Control Technology. March: The Association for the Advancement of Medical Instrumentation. Safe handling and biological decontamination of medical devices in health care facilities and in nonclinical setting. ANSI/AAMI ST35: MANAGING INFECTION CONTROL

19 5. h t t p : / / w w w. b e e r e m e d i c a l. c o m / P r i n t s / p d f / Guide-Instr.520care.pdf. 6. Australian Infection Control. Relative efficacy and activity of medical instrument cleaning agents. Volume 7, issue 3, 9: h t t p : / / w w w.cleaning101.com/cleaning/chemistry 8. Criti-Klenz : :label instructions. 9. MetriWash : :label claim. 10. Endozyme. AW-triple Plus with a A.P.A.(R); 345A.P.A., label claim. 11. AV E N ATECDH, INC washer/decontaminators- In-Service Training Guide-Operation of the Belimed. SM-100: Basile, Browne, Kovach. Measuring Clean in Central Service. Managing Infection Control. 8: h t t p : / / w w w. m e d i s a f e u k. c o. u k / s g j l i b / d e f a u l t. a s p? s r c = i t e m & i d = { 0 f 7 1 E 4 B E - 4 B E 7-4 A A B 6 C A 2 8 D 1 A C E E } & t i t l e = Wa s h e r % 2 F Dsinfection+Test+Soil. 14. h t t p : / / w w w. h e a l t h m a r k. i n f o / p r o f o r m a n c e. h t m l. 15. Alfa, Nemes. Y J H I W /6/ : 05- DMESSENGER MOEDLG-pp Basile, Kovach. The Cleaning Process. Managing Infection Control. 7: Chobin, Nancy. Role of Central Service in Infection Control. Nebraskaland Central Service Meeting. 10/19/ ZenSentrile Forum 2004, Martin We i d e r, Dosage and Control Mechanisms in Validation of Automated Cleaning and Disinfection Processes. 19. and then there was Decontam. Richard W. Schule; Paper submitted for the Ruth A n n e Brooks,RN Past Presidents award IAHCSMM. Stephen M. Kovach is the director of education for Healthmark Industries in St. Clair Shores, Mich. He has been in the hospital field for more than 30 years. Stephen has been active with his state and national Central Service org a n i z a t i o n s, having held many leadership positions. He also belongs to the Michigan Lakeshore Chapter #2307 of AORN. He has received recognition in both his personal and business profession. Stephen is very proud to say he has WORKED IN CENTRAL SERVICE. Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for 1.5 contact hours for a period of five years from the date of publication and to be used once in a re-certification period. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding Certification contact: CBSPD, 2 Industrial Park Road, Suite 3, Alpha, NJ or call or visit Web site at IAHCSMM has awarded 1.5 contact points for completion of this continuing e d u c a t i o n lesson toward IAHCSMM recertification. Nursing CE Application Form 3M Health Care provider approved by the California Board of Registered Nurses, CEP 5770 for 1 contact hour. This form is valid up to five years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control s receipt of the application. Application Please print or type. Name Mailing Address City, State, Country, Zip Daytime phone ( ) P o s i t i o n / Ti t l e Social Security or Nursing License Number Date application submitted ANSWERS 1. T 2. T 3. T 4. T 5. T 6. T 7. F 8. F 9. T 10. T Signature _ Offer expires February 2012 On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program for the following: 1) Overall content 2) Met written objectives 3) Usability of content <02/07> Reprint with permission from Workhorse Publishing L.L.C Copyright 2007/Workhorse Publishing L.L.C./All Rights Reseved. MANAGING INFECTION CONTROL 103