Stephen M Kovach Surgical Products Specialties & Healthmark Industries Present The College of Clean Running a Medical Devise Reprocessing Department(MDRD) requires a lot of Knowledge They say every picture tells a story.so today I will use lots of pictures to tell the story of Cleaning. Why talk about cleaning? Well because cleaning is so easy. You brush and flush a few times and it is cleanor you just put the medical device into a sonic or a washer and it comes out clean, RIGHT?! Up to 12,000 children and young adults treated at Seattle Children s Bellevue Clinic and Surgery Centersince 2010 could be at risk of infection from surgical instruments that may not have been properly sterilized. The lapse was discovered Thursday, 8/20/15, when staff examined some instruments that should have been clean but had tiny amounts of debris on them, said Dr. Danielle Zerr, medical director for infection control. The evidence that there were problems was actually very subtle, she said. This is the second time in two years that Seattle Children s has alerted patients about problems with sterilizing surgical equipment. http://www.seattletimes.com/seattle-news/health/seattle-childrens-bellevue-clinic-warns-of-exposure-to-potential-risk-of-infection/ Disclosure I am an employee of Healthmark Industries Fraser, Michigan USA I am involved with the manufacture and distribution of medical products to healthcare facilities and healthcare professionals No compensation has been received for this presentation or for travel to and from the seminar All opinions are those of the presenter I will show you the Good Bad Ugly Why To drive home the point that cleaning verification must be part of every MDRD Common processes between countries Standards require up to have continuing education and it should be provided at regular intervals to review and update worker knowledge and skills and to maintain their competency and certification That you MUST understand the cleaning process completely Trust but verify Today 1
Why are you here today? Z314.0-13 6.3 Orientation, training, and continuing education Continuing education programs for reprocessing shall be provided at regular intervals so that personnel can review and update their knowledge and skills. Because you are a professional Compliance with standards is poor is poor in the US Recently, Becker s Clinical Quality and Infection Control update reported: The Joint Commission has identified the five most challenging hospital accreditation standards in the first half of 2013. The five standards that were most frequently deemed not compliant for hospitals in the first half of the year, along with their noncompliance rates. Number 3 out of 5 The hospital reduces the risk of infections associated with medical equipment, devices and supplies (IC.02.02.01) Going up in %» 47% in 2013» 42 % in 2012» 36% in 2011 The Dirty Facts are still true today Surgical Site Infections Cost at least $5 Billion a year. Potential causes: Break in sterile technique Poor patient health Unclean instruments Unsterile instruments We can reduce or control 3 of the 4 causes This is why you are here today. Watch this short video: CDC 1999/CAH focus group February 2003 Managing I.C. Volume 4,issue 1 Housekeeping Issue We are family Who is here today? Questions during all of the presentations Raise your hand any time Pictures help tell a story, you will see a lot of them today Cell phones off I need you to fill out my survey Ready? Let s go! One last note -I need to help us make a change in how we think of ourselves. 2
Lots of different items They arrive in various states and conditions from your customers for you to clean and get ready again. No. 2: MDRD are alike, sometimes you have to make do with what you have. What is an MDR Medical device reprocessing department (MDRD) a functional area that reprocesses reusable medical devices (not necessarily centralized). In smaller health care settings such as clinics or offices in the community, this refers to any segregated area where reprocessing of reusable medical devices takes place, away from patients. Reprocessing the process of rendering a potentially contaminated medical device safe and effective for use on a patient. This includes cleaning, disinfecting, packaging, and sterilizing the medical device as required, and can include sharpening, repairing, relubricating, and recalibrating. The supply of sterile goods requires a chain of activities within a MDRD. All steps have to be performed well. We will be talking about one of those chains called Cleaning. We have many processes in a MDRD Each Process has various tools Brushes for cleaning Sterilizer for killing Tests to make sure scissors are sharp Pouches to keep things in Racks to store supplies Testing your heat sealer Today we will focus on cleaning 3
Objectives To understand Cleaning, you must understand: The definition of Cleaning The 9 factors of cleaning and how they interact We will review all of these points to increase your knowledge of cleaning and how it relates to: Manual Sonic Medical washer Flexible scopes Cart washers Let us look at some Clean Facts first and class is in session Clean facts 16% of the loaner instruments tested positive for blood ( AORN Journal;3/2007,Volume 85,#3; page 566) When placing the tissue protector on the drill, old dry blood and tissue came out (Pennsylvania Patient Safety Authority 2006;page 1) Particles of tissue were found in cannulated instruments (Pennsylvania Patient Safety Authority 2006;page 1) The investigative report said a surgical tool used for inserting a screw in a broken bone was not properly prepared before being sent to be sterilized, containing biomatter from a previous patient that should have been removed, the report said.* *6/22/12- http://health.heraldtribune.com/2012/06/22/venice-hospital-re-trainsstaff-after-contaminated-instruments-were-used/ Is this really hard water? There has been a growing concern about the effectiveness of decontamination technique for reusable medical instrumentation in healthcare facilities. 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.* *Alfa,M.,etal, 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; 17:92-100 What is an IFU in Canada US meaning of the term Instructions for Use (IFU) AAMI ST 79 Canada meaning of the term Manufacturer s Instructions(MIFU) Z314.8-14 Over 130 times this term appears Shall The word shall appears at least 310 Section 1.4 In this Standard, shall is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with the standard IFU = Manufacturer s instructions for this presentation You must follow the correct process or you could be in trouble Today let us just use the term IFU Following the IFU A validation of the cleaning and sterilization procedure by the manufacture For cleaning, it is a procedure to remove residual patient soil and must be completed by the device manufacturer This validation should be part of the submission package and will be examined by the U.S. Food and Drug Administration (FAD) during its review The goal of cleaning validation is to prove that when the instructions in the IFU are followed, the residual soil levels on the device will have been reduced to acceptable levels It is important to note that completion of a successful cleaning validation alone does not ensure that devices reprocessed by the end user are clean The end user s ability to perform the cleaning by understanding and following all steps in the IFU is vital The Process Manufacturers of reusable medical devices provide users with reprocessing instructions, including cleaning instructions. Cleaning instructions should be validated by the manufacturer as being effective to remove soil Manufacturers validate cleaning by performing simulated soiling and cleaning of the device, followed by some measurement of residual debris Users follow these Instructions for Use (IFU) 4
Reprocessing of Medical Devices: Who is responsible for What? Manufacturers validate that an instrument can be reliably cleaned and sterilized/disinfected and is therefore reusable. Usersverify that cleaning / sterilization equipment is working and that in-hospital cleaning / sterilization methods are consistently performed Following the IFU is not easy for the MDRD Some feel they are not practical Time is a factor Staff do take short cuts Pressure to get the medical device clean, assembled, sterilized Medical facility takes on the legal aspect and liability when they skip steps in the process Need for monitoring and testing of the cleaning process Three examples Example # 1: Your Customer Survey of 334 OR Nurses Poster: AORN 2014 Annual Meeting, Perioperative Nurse s Knowledge of the Cleaning and Decontamination Process of Surgical instruments -Mary A Hillanbrand, DNP, RN, Major, USAF, NC, CNOR Some of the results: 80% have a policy on Point of Use Cleaning 23% maintain manufacturers IFU for use in the surgical suite 59% initial orientation <1 day in decontamination area of OR 64% initial orientation < 1 day in decontamination area of SPA 28% DO NOT KNOW inadequate cleaning/sterilization of OPHTHALMIC INSTRUMENTS has been linked to most cases of TASS 20% DO NOT KNOW instruments should be cleaned at the point of use with a soft lint-free gauze moistened with STERILE WATER 28% DO NOT KNOW the initial cleaning of surgical instruments BEGINS at the point of use at the surgical field Endoscopes Poster -IAHCSMM* Example #2: Cleaning Your Flexible Scope 57 % did not brush all channels and components 55% did not dry with force air 22% leaked tested with sudsy water 10% skipped final wipe down 45% missed multiple steps 99% missed 1 or more steps or done incorrectly 1% all steps completed correctly Hawthorne effect *Information taken from a poster presentation at IAHCSMM Annual Conference May5-8,2013 Ofstead & Associates Endoscope Reprocessing : evaluating Guideline Adherence 5
Factors Leading to Outbreaks from Endoscope/Bronchoscope Contamination Contaminated water supply Contaminated brushes for cleaning scope lumens Improper manual cleaning prior to disinfection Biofilm inside automatic washer Improper use of automatic washer Contaminated or expired disinfection reagent Inability or neglect to clean the suction channel Mechanical or design issues related to the Endoscope/bronchoscope Bottom line Training Not following the IFU Example # 3: The Shaver Example #3 The Shaver The Shaver Problem A highly publicized outbreak at Methodist Hospital in Houston, Texas, was caused by biofilm transmitted between patients who underwent arthroscopic surgery. Upon investigating the outbreak, the FDA noted small pieces of tissue remained inside shavers, which reportedly resulted in biofilm colonization inside the hand pieces. The organisms were transmitted even though the central sterile staff had followed the manufacturer's reprocessing instructions and the instruments had been steam sterilized between uses. SPD/CPD now has a Shaver Issue The FDA has become aware of events in which tissue has remained within certain arthroscopic shavers, even after the cleaning process was believed to have been completed according to the manufacturer's instructions (April 2009). Reports submitted to the FDA suggested that the tissue retained was not evident to the naked eye. Multiple manufacturers of these devices recently informed their customers of this situation and reiterated the importance of proper cleaning procedures. The Real Problems Highlighted June 8-9,2011 FDA Summit on Clean Report by Smith and Nephew concerning the shaver and following the cleaning steps in the IFU 12 Facilities practices were audited 78 devices (shavers) were audited (observed) None of facilities complied with all of the cleaning instructions found in the IFU 95% of devices had observations of residue on internal surfaces Majority of residue in two areas (lumen step, drive fork area) Hawthorne effect 6
Clean inside the lumen step area Must brush both ends Clean inside the drive fork area Changes made in the IFU Change in cleaning instructions by device manufacturers The visual inspection step was enhanced to look into those difficult areas of the hand piece IFU Support for using a Flexible Inspection Scope Arthrex-AdapteurPower System II (APS II) Shaver Hand pieces -DFU- 0154r10* INSPECTION AND MAINTENANCE Step 4 in the DFU (IFU) Check device for visible soil. It is recommended that the cannulation be inspected with an illuminated, magnifying scope. Clean the device using the guidelines for manual cleaning if any soil is visible. *www.arthrex.com STRYKER Shaver HandPiece - 1000400638 R-2012/10 * INSPECTION EN 21 Step 9 Visually inspect the hand piece, including all internal surfaces, for remaining soil. Use an endoscopic camera and endoscope if necessary to see the inner surface of the lumen. If soil remains, repeat the manual cleaning procedure, focusing on those areas * www.stryker.com MDRD need solutions Solutions based on the FDA recommendations and the medical device IFU Get the correct cleaning tools Cleaning solutions Air/water spray guns Correct size brushes Flexible Inspection Scope New IFU if followed should reduce or eliminate this issue Document and record results for legal concerns Healthmark has the solutions* Brushes Spray guns (air/water) Flexible Inspection Scope *Please note that Healthmark does not sell cleaning solutions Ask yourself this: Do you have the right tools? Brushes Other cleaning tools Flexible Inspection Scope Are you following the IFU and can you prove it? With the Shaver Documentation "In court, the medical record is the care rendered," they say. "Jurors view good record keeping as an indicator of good care poor documentation can create an aura of poor care and damage the credibility of the healthcare providers. If it wasn't documented, it wasn't done. http://www.outpatientsurgery.net/surgical-facility-administration/avoid-medical-malpractice/how-to-survive-a-med-malsuit--orx-proceedings-13?utm-source=tod&utm-medium=email&utm-campaign=tips 7
The 3 examples given show why an MDRD must follow the I.F.U. This sums up the IFU issue Legal Provide the best outcome Doing the process the right way each and every time Auditors are asking you, are you following the I.F.U.? Where do you keep the I.F.U.? Changes Now let us look at Cleaning: Define Cleaning Standard is: visually clean Define the 9 factors of cleaning Everybody has a part in cleaning Instrument sets that have come back to the S.P.A. for rejuvenation Definition of Cleaning - US Removal of contamination from an item to the extent necessary for further processing or for the intended use. In health care facilities, cleaning consists of the removal, usually with detergent and water, of adherent organic and inorganic soil (e.g., blood, protein substances, and other debris) from the surfaces, crevices, serrations, joints, and lumens of instruments, devices, and equipment by a manual or mechanical process that prepares the items for safe handling and/or further decontamination. 2010 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010-2.17 Definition of Cleaning - Canada Cleaning removal of contamination from an item to the extent necessary for its further processing and its intended subsequent use. Note: Cleaning is essential prior to disinfection or sterilization as the effectiveness of disinfection or sterilization processes can be impacted by residual debris or soil on instruments. In addition cleaning (manual, automated) removes visible debris and visible soiling to render the item safe for further handling by persons involved in reprocessing when these persons use appropriate barriers (e.g., gloves, gowns, and face protection). Z314.0-13 Medical device reprocessing General requirements - 3 Definitions The Power of Cleaning By cleaning, the population of micro-organisms residing on the materials (known as the bioburden) is reduced considerably. The initial contamination for a subsequent disinfection or sterilization is considerably lower and thus these processes will be more effective, as much less organisms have to be killed. 8
Steps in the Cleaning Process User s role How it is used How it is sent back Sorting S.P.A. Role Pre-rinse/soaking Washing Manual Scrub & rinse Automatic Medical Automatic washer Medical Sonic cleaner Medical Cart washer Combination process Inspection of the medical device is ongoing constantly Let us look at the 9 factors: 9 factors Medical device to be cleaned (simple or complex) Type of soil to be cleaned (blood, synovial fluid ) Water quality (ph, hardness ) Temperature (cycle, cleaning solution ) Chemical activity (cleaning solution) Mechanical action (manual, automatic) Human factor Standards and guidelines (AAMI, FDA, AORN ) Verification of the process (what do I use?) Cleaning Factor # 1: Medical Device To Be Cleaned Back in the day 1950, 1960, not much changed Since 1970 -Change has taken place Long narrow lumens Tiny serrations Multiple parts Various metals and plastics M.I.S. is now the norm not the exception any more Incomplete information from the manufacturer on how to clean the item Two groups of Instruments #1: Medical Device To Be Cleaned Two Groups: Equipment Feed pumps Focus on Instruments Back in the day 1950, 1960, not much changed Since 1970 - change has taken place Long narrow lumens Tiny serration's Multiple parts Various metals and plastics M.I.S. is now the norm not the exception any more Incomplete information from the manufacture on how to clean the item Two group of Instruments Simple Devices without challenging design features Bone spikes Osteotomes Simple surgical instruments Complex Devices with challenging designs 9
Did you really follow the IFU? Universal Drill Guide http://www.synthes.com/sites/intl/medicalcommunity/reprocessingcaremaintenance/pages/dismantling-multipart-instruments.aspx http://www.synthes.com/sites/intl/medicalcommunity/reprocessingcaremaintenance/pages/reprocessing-care-maintenan.aspx Synthes homepage 10
MIS Instrumentation Three types Non ported Ported not take apart Ported and take apart They have lumens and this is an issue We will talk about lumens after MIS instruments in general Non-ported MIS Instruments- difficult to clean-get rid of them-now!!!!!! What was inside of a Non-ported Instrument #2: Type of Soil to be Cleaned The presence of organic material, such as blood, can result in the failure of sterilization or disinfection. This may be because either the organic material protects the microorganisms from exposure to the process, or because the process may be inactivated by contact with organic material. What is on the medical device? Where was it used? Bio-burden Blood Fibrin Protein Fecal matter other Out of all of the concerns, blood seems to be the hardest to clean and poses the highest risk. So let us look at blood. 11
Key Components of Blood Soil Blood is the #1 Challenge Hemoglobin becomes highly insolvent when it dries out. Fibrin, the coagulating agent in blood, is inherently water insoluble. Blood denatures at temperatures above 45 o C (110 o F). When blood denatures, it becomes 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. Quality of water Hardness ph Know the source of your water Impacts your cleaning chemistry choices Purest source for rinse Examples of poor water quality Staining Pitting BioFilm Z314.0-13 - 7.8.1 Water quality is an important consideration in all stages of medical device reprocessing For further guidance, see Annex E of this Standard and AAMI TIR34 #3: Water Quality Water Quality TIR 34 This TIR defines two levels of water quality suitable for medical device reprocessing, and it describes the water treatment processes that can be used to obtain the correct water quality. To provide optimal water for medical device reprocessing, reprocessing personnel and water maintenance personnel should collaborate with administrative personnel to implement the following procedures. Referenced in your standard Updated TIR 34 provides answers to water quality questions TIR 34 Section 4.2 Defines two categories of water quality: Utility water comes from the tap and usually in need of no further treatment» Primarily used for flushing, washing and a general rinse Critical water is treated extensively to ensure that microorganisms and inorganic and organic material are removed» Typically used for final rinse or steam generation The decision regarding the need to treat incoming tap water to provide adequate water for medical device reprocessing should be undertaken in every facility that reprocesses medical devices ph The ph scale measures the acidity or alkalinity of a liquid. The ph scale is logarithmic, which means that the steps in between the numbers increase by 10 times. Therefore, as you move up the scale from 7 each step is 10 times more alkaline than the last, and moving down the scale from 7 each step is 10 times more acidic. 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. 12
Types of Water Potable Water that has been treated and delivered in a manner so that it meets EPA guidelines as suitable for drinking. Softened Technique that removes ions that cause water to be hard (usually calcium and magnesium, but iron ions may also be removed by softening). Deionized Water treatment process that uses specially manufactured ionexchange resin to remove ionized salts from the water. R.O. Membrane separation process for purifying water that is based on molecular sieving and ionic rejection and that is effective in removing ions as well as dissolved organic contaminants with molecular weights above 100. Who Is Telling You What Type of Water to Use? Equipment manufacturer of your washer, cleaning solutions label, catalog, IFU Standards and guidelines Professional groups (IAHCSMM, AORN, APIC) in their guidelines At the half way point! The Clean Brothers say STAY AWAKE!!! #4: Temperature Hotter is better. Except that this would be wrong. Get the temperature right. The proper water temperature is different for each type of cleaning and for each stage of cleaning. The proper temperature also varies with the cleaning agent (e.g., Enzyme cleaner, detergent) used. Are you using the right temperature at each stage? Low temperature to start (to prevent denaturing) and higher temperature later to maximize detergent cleaning efficiency. The denaturing action of heat on blood makes it insoluble enough to interfere with rapid cleaning. Start with a cool rinse. Use the recommended temperature for all cleaning agents. TempaChekDL Datalogger Washers fail to clean for many reasons. Temperature is one of the reasons. A data logger provides a means of monitoring the temperature at various stages within the automatic washer that influence the effectiveness of a washer. Example of a washer cycle notice prewash temperature is High using a data logger 13
Temperature & Dilution Temperature Monitoring Factor #5: Cleaning Solutions Need good water quality Hardness ph Lots of choices each have their own + or The four basic classes of enzymes are: Lipase - breaks down fats and greases Protease - breaks down protein Cellulase-breaks down cellulose such as wood, cotton, and paper Amylase breaks down carbohydrates and starches Manual detergent cleaners Low foaming - neutral Cleaners for ultrasonic equipment Cleaners for mechanical washer (carts/instruments) Acid & Alkaline cleaners Selected for suitability to job How do Cleaning Solutions work? Three types of energy that is needed for good cleaning Chemical energy ; provided by cleaning agent (poor water = poor outcome) Thermal energy ; provided by warm or hot water Mechanical energy ; provided by a machine or manual (hands) #6: Mechanical Action Manual Machine or Automated Manual Cleaning: The vast majority of the cleaning action is caused by the mechanical action. Machine Cleaning: A large share of the cleaning action is now taken over by chemistry, temperature and time. 14
Manual Cleaning Manual process Brushing, the right size brush for the task at hand Flushing, rinsing Time and tools Try to have a three tank sink Try to have an air hose Try to have a water hose Monitor the cleaning area temperature and humidity Monitor the air flow negative pressure Use the Proper P.P.A. for each type of cleaning Meter/monitor temperature and dilution of all solutions Use ST 79 as your guide Mechanical Action Mechanical Failure does happen Poor preventive maintenance on equipment Not following the manufactures PMA program (short cuts) Unqualified technical staff doing PMA Dilution pump failures Pressure problems Sonic equipment not working Transducers not functioning properly Broken Soap pumps Blocked Spinner Arms Defective wash pumps Missing arms Overloaded Rack One failure will result in a failed process #7: Human Factor How S.P.A. and its customers (OR, ER, Endo) interact with the medical devices/instruments after a procedure has a dramatic impact on the net result Pre-clean Pre-soaking or enzymatic spray Overload the basket and racks Disassembling instruments Follow the IFU Staffing Work flow design Having the correct tools Management decision Understand the consequences of your choices Training Certification Yearly testing on process Human factors Chemicals of all kinds Everyday life Instruments every place We still have to get the work done with what we have You need the right tools to Get the work done right Spray guns Vertical soakers Proper Brushes Verified equipment Magnifying glass Sonic cleaners Equipment that works Education and training #8: Standards and Guidelines 15
What are these based on? #9: Verification of the Process Clinically relevant & evidence-based practices Peer-reviewed literature Other articles Manufacturers research and guidance Research and science Unfortunately, some practices do not have the evidence to support the practice Dynamic process All the major groups support in principal Quality improvement Quality assurance Monitoring of your process Quality improvement program Medical device verification Equipment Surfaces Surgical instruments Visual inspection Site/surface testing Stain identification Best way to verify & improve the process is a Quality Improvement Program. Focus PDCA Lean, Six Sigma others Trust but Verify Let us look at Verification Understand your process first First, flow-chart your cleaning / 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. Medical Device verification Equipment Verification Medical Device & Equipment Verification to make sure clean Instruments are Produced Man & Machine are combined to achieve these results Both are not perfect Thus regular inspection/testing at each critical juncture helps ensure the highest levels of assurance Until recently cleaning equipment wasn t being challenged Automated Washers, Sonic Cleaners, Cart Washers, and instruments were not being tested Surrogate devices and test soil that represent real life conditions as best as possible Think Crime Scene Think of the medical device as part of a crime scene You need various tools to find out what is on that dirty medical device visual inspection various test methods for the surface of the medical device You need to put on your detective hat and find out: What is on that dirty medical device? Equipment is not cleaning properly Verify it is working properly You want to be a C.S.S.I. Central Sterile Supply Investigator What markers should be used for user verification for cleaning? Literature supports usingthe three most predominant contaminants that are the main components of bodily fluids, protein, hemoglobin, and carbohydrates, as markers.* Regulatory authorities (like the FDA) will be looking for results from device manufacturers for two markers of the test soil chosen (for example, protein, hemoglobin, mucus).* Alfa has shown that for flexible scopes: Protein; < 6.4 µg/cm2, Carbohydrate; < 1.8 µg/cm2, Hemoglobin; < 2.2 µg/cm2, are excellent markers for cleaning validation and verification.** At this time, ATP is not a marker accepted by the FDA for cleaning validation Users should look at testing for the same markers to verify their process as the manufacturer of the device *The source for all of this information is taken from : A White Paper ;The New Scope of Reusable Device Cleaning Validations-By: Patrick Kenny;Microtest-2011 **Alfa MJ et al A Survey of reprocessing methods, residual viable bioburden and soil levels in patient-ready ERCP duodenoscopes used in Canadian centers. Infect Control Hosp Epidemiol 2002;23:198-206 16
Verification - CSA Z314.8-14 6.2 Verification Testing of cleaning efficacy and thermal disinfection should be done in accordance with CAN/CSA-Z15883-1. 7.3.5.6.2 Commercially available indicators or test kits shall be used at least once per week to verify cleaning efficacy CAN/CSA-Z15883-1 4.2.1.1 Cleaning shall be deemed to have been achieved if the acceptance criteria for the test method in 6.10 and the relevant subsequent parts of ISO 15883 have been met. The test method for type testing and operational testing (6.10.2) shall employ one of the nationally published tests oils and methods as described in ISO/TS 15883-5 Additional verification of attainment of the required cleaning efficacy during operational testing can be provided by the use of one of the methods for the detection and assessment of residual protein given in 6.10.3 and Annex C. Steps in the Cleaning Process User s role How it is used How it is sent back Sorting S.P.A. Role Pre-rinse/soaking Washing Manual Scrub & rinse Automatic Medical Automatic washer Medical Sonic cleaner Medical Cart washer Combination process Inspection of the medical device is ongoing constantly Does this look familiar? Robotic arms coming back from surgery they need to be moist and wiped off Fresh from the O.R. 17
Items being returned to MDRD improperly DHT is the KEY This stands for Decontamination Holding Time. This is the time from when the instrument is last used to when it is received in decontamination and the cleaning process begins. This can vary in length of time from just a few minutes to hours or even days. * to prevent the formation of biofilm, definitive cleaning should occur as soon as possible. Prior to transport, instruments should be prepared in such a way as to prevent organic soils from drying. This can be accomplished by placing a towel moistened with water (not saline) over the instrument, placing it inside a package designed to maintain humid conditions, or using an instrument spray designed for pretreatment *2012 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 & A1 & A2 & A3; page 48 Various guidelines and standards Perioperative Standards and Guidelines AORN 2013 RP 4 page 431 - instruments should be wiped as needed during the procedure to remove gross soil Hinged medical devices should be in the open position PDCA Items being returned Plan What do we want to solve Better point of use cleaning Items returned properly Moist Clean /wiped Instruments being strung Do Design a survey Check standards Study / Check Review data Act Now what? This process does work Returned items Check the standards and guidelines AST AORN AAMI Others Collect Data Put a plan in place Use data to make changes How to stop this practice - Use your customer s guidelines. AORN Standards, Recommended Practices, and Guidelines 2013 Edition RP 4 page 423 should be kept free of gross soil during surgical procedures AST- Standard of Practice I* The cleaning of instruments should begin during the surgical procedure to prevent drying of blood, soil and debris on the surface and within lumens. 1. The CST in the first scrub role should keep the instruments free of debris and blood during the surgical procedure. a. The instruments should be wiped clean using a sterile, watermoistened sponge. Care must be taken that the sponge is not used on the tissues of the patient. b. Instruments with lumens should be flushed with a sterile, waterfilled syringe to remove blood and debris and prevent drying of the gross soil. c. Instruments that may not be used for the remainder of procedure, eg, acetabular reamers used during a total hip arthroplasty, may be placed into a basin containing sterile water to soak. d. Saline must not be used, since the chloride ions can cause pitting and deterioration of the finish on the surface of the instruments. *www.ast.org - Recommended Standards of Practice for the Decontamination of Surgical Instruments Manufacturers of Instruments After Use Open Instrument with a joint to a 90 angle* For machine cleaning, place the instrument in a wire basket suitable for the cleaning process, (make sure the cleaning solution and rinse water from the machine can come into contact with all surfaces of the instrument)*. *Source AesculapSurgical Instruments Care and Maintenance of surgical Instruments Catalog ;page X After Use All instruments from a procedure, including ones not used, should be completely opened and cleaned (Source SSI Catalog page iii) All instruments must be fully submerged in the open position (Source Miltex, Cleaning, Sterilization and Maintenance of Surgical Instruments Catalog) The list goes on just check any Instrument catalog You can change the practice of improperly returned medical devices, but remember it will take time and team work. 18
Understanding Manual Cleaning Any device should be able to be manually cleaned 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST79:2010 & A1 & A2 & A3 & A4 - page 57 If manual cleaning is required, the medical device manufacturer s cleaning instructions shall be followed, including any specifications for detergent type, water type, or water temperature and cleaning methods. 7.3.2 Manual cleaning Manual cleaning: The vast majority of the cleaning action is caused by the mechanical action. Machine cleaning: A large share of the cleaning action is now taken over by chemistry, temperature and time Manual Cleaning Manual process Brushing, the right size brush for the task at hand Flushing, rinsing Time and tools Try to have a three tank sink Try to have an air hose Try to have a water hose Monitor the cleaning area temperature and humidity Monitor the air flow negative pressure Use the Proper P.P.A. for each type of cleaning Meter / monitor temperature and dilution of all solutions Manual Cleaning Process Continued Forced air should be provided at the sink, as well as faucets or manifold systems for flushing lumened devices. The decontamination area must have an emergency eyewash/shower station Ergonomic factors affecting worker safety and comfort should be considered when designing work spaces. Manual Cleaning Process Continued When manually cleaning, instruments should be washed in a manner that provides proper decontamination Although automated methods are preferred, some delicate instruments (eg,eye,microsurgery) and power equipment require manual cleaning Aerosolization, injury from sharps are possible when manual cleaning is performed AORN 2008 Recommended Practices page 427-429 19
Manual Cleaning Process Continued Luke warm water and detergents At temperature range of 80-110 F Prevent coagulation and thus assist in the removal of protein substances Temperature should be monitored and documented Also water hardness, ph, temperature Thoroughly rinsed to remove debris and detergent residues 7.7.2 Temperature and relative humidity* Temperature and humidity levels should be monitored and recorded at least daily with a commercially available programmable data logging The room temperature of reprocessing work areas shall be within the range of 18 to 20 C for decontamination and 18 to 23 C for all other clean areas. Relative humidity of the decontamination areas shall be maintained in a range of 30 to 60% and preferably in the range of 40 to 50%. *Z314.0-13 Air Flow Watch this video on negative pressure Room Monitors Manual Cleaning Process Continued Lighting requirements Physical Separation NonPorous material Floor, ceiling, work surfaces Workflow is important Adequate space for activities 20
Manual Cleaning Everything can be manually cleaned and you must have that on file Have the right tools to do the job Understand your process Train your staff Manual Cleaning Process Continued Space For everything Hand washing Body-fluid disposal systems Computers You name it Everything stated so far is right from AAMI ST 79. You need the right tools to Get it Clean Just as a carpenter needs special tools to do their job correctly so does a Central Service Professional. They need those same special tools to get it clean when doing manual cleaning! Here are some examples Spray guns Vertical soakers Proper Brushes Verified equipment Magnifying glass Quality Improvement Program Personal protection when cleaning 21
A spray gun is essential for rinsing/flushing of hollow instruments. Various nozzles are available for a range of specific cleaning applications. The hand shower can be used for an initial rinse of instruments. Use a deep basin, which will help to prevent splashing sideways. Make sure that the water pressure is not too high in order to limit splashing. Only use cold water for blood removal! Protect yourself by wearing gloves and mask, or use a splash screen. Cleaning of Reusable Brushes Delicate instruments, such as optics, may be cleaned by soft towel (low linting) or sponge. CSA Z314.8-14, Section 7.3.2.4, Page 25 Visual inspection of brushes includes attention to worn or missing bristles, exposed metal, rust, and capacity for buildup of bioburden that could damage medical devices. Single-use or damaged cleaning accessories shall not be reused. Reusable cleaning accessories shall be decontaminated at least daily, dried, and stored in a dry, clean location, and in accordance with manufacturer s instructions. CSA Z314.8-14, Section 11.9.1.5.3, Page 62 Reusable brushes shall be discarded when bristles are worn, frayed, bent, or otherwise damaged. Must use the right size brush Brush Sizes It's absolutely necessary to use the appropriately sized brush -diameter of the brush is critical to letting bristles create friction against the walls of the lumen. If you use one that's too big, the bristles will bend back and won't scrub debris away, and you risk scratching the inside of the cannula. Too small, and you won't create any (or at least not enough) friction between the bristles and the inner walls. The standard French, or Charriere, Scale (abbreviated Fr.) is generally used in the size calibration of catheters and other tubular instruments. It is based on the metric system, with each unit being approximately 0.33 mm in diameter between consecutive sizes. A simple guide 1mm =.039 inches = 3Fr 2mm =.079 inches = 6 Fr 3mm =.118 inches = 9 Fr 4mm =.158 inches = 12 Fr 5 mm =.179 inches = 15 Fr 6 mm =.236 inches = 18 Fr mm = millimeter Fr= French 22
Many styles many kinds Example of just 3 sizes For flat surfaces Lumens items Orthopedic Endoscope Special design for specific purposes Close up notice the size Closing words of advice on Brushes Close with some pictures Brushes size does matter Right size is important Pick the right brush for the task at hand Be sure to keep the instrument completely under the waterline when you brush. Never brush outside the water, as you want anything you pull out to stay under the water. If single use -use only once If brush is reusable, follow the IFU to properly re-use that brush. Story of TJC and brushes in NJ 23
Water Quality Even Block products have issues NO Dilution -Get it right! 24
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Break Time History of Cleaning Verification in North America Timeline pre-1999 - visually clean (sterile dirt) The Joint Commission has always supported the testing and monitoring of medical equipment 1999 - cleaning verification arrives - TOSI 2001 - Healthmark introduces TOSI to North American market 2002 -present: additional products are introduced to address cleaning challenges (Sonocheck, Endocheck, CartWashCheck) 2006 ASTM sets standard for medical automatic washers 2008 - AORN Recommended practices of at least weekly testing 2009 - AAMI ST79 Recommends practices of at least weekly testing 2009 -present: other companies offer cleaning verification products in N.A., not all of them are clinically relevant, evidenced-based products Healthmark's philosophy More than just running a test, it is a quality improvement process Clinically relevant, evidence-based products Support of products both clinically and educationally 26