Presentation on theme: "Best Practices for High-Level Disinfection (HLD) Presented by Crosstex/SPSmedical Chuck Hughes, VP of Infection Prevention & Consulting."— Presentation transcript:
1 Best Practices for High-Level Disinfection (HLD) Presented by Crosstex/SPSmedical Chuck Hughes, VP of Infection Prevention & Consulting
2 Objectives At the end of this program, participants will be able to: Explain the Spaulding Classification System for the reprocessing of reusable medical devicesUnderstand the importance of effective cleaning and decontamination prior to HLDIdentify commonly used agents for HLDDiscuss SGNA recommended steps for the HLD of flexible endoscopes
3 Spaulding Classification System In 1968, Dr. Earle Spaulding devised a rational approach to disinfection and sterilization that is still in use todayHe believed that instruments and equipment should be reprocessed according to the nature of the item and the level of risk associated with their intended useThis is referred to as Spaulding's Classification System and it has been refined and retained over the years, because it is so clear and logicalThe three (3) categories he described were critical, semi-critical and non-critical
4 Spaulding Classification System Critical items are medical devices that enter sterile tissue or the vascular systemThese items should be sterile when usedExamples include, but are not limited to:surgical instrumentscutting endoscopic accessories that break the mucosal barrierendoscopes used in sterile body cavitiescardiac, vascular or urinary cathetersimplants, needles and ultrasound probes used in the sterile body cavities
5 Spaulding Classification System Semi-critical items are medical devices that come into contact with non-intact skin or mucous membranesThese items should be high level disinfected when usedExamples include, but are not limited to:vaginal and rectal probesanesthesia equipmentLaryngoscopesBronchoscopesGastrointestinal endoscopes (and accessories)
6 Spaulding Classification System Non-critical items are medical devices that come into contact with only intact skinThese items should receive intermediate level disinfection, low-level disinfection or cleaningIntact skin is considered an effective barrier to most organismsExamples of non-critical items include, but are not limited to:TourniquetsBlood pressure cuffsLinensBed pansStethoscopes
7 Three Levels of Disinfection The terminology adopted by the CDC and widely used, describes disinfectants in terms of their activity as set out below. This program will focus on high-level disinfection (HLD).High-level disinfectants are chemical sterilants, which when used for a shorter exposure period than would be required for sterilization, kill all microorganisms with the exception of high numbers of bacterial spores.Intermediate-level disinfectants may kill mycobacteria, vegetative bacteria, most viruses, and most fungi but do not necessarily kill bacterial sporesLow-level disinfectants may kill most vegetative bacteria, some fungi, and some viruses.
8 Cleaning and Decontamination Pre-cleaning must occur at point of use in order to keep blood and other organic material from dryingBlood and body fluids, as well as saline, are highly corrosive and can damage instrumentsDried blood and debris is difficult, if not impossible to clean during decontamination, which can cause disinfection or sterilization not to be achievedSurgical instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soilInstruments with lumens should be irrigated with sterile water
9 Cleaning and Decontamination Flexible endoscopes used on the sterile field should be pre-cleaned to the following recommended steps:Wipe external surfaces with a lint-free cloth saturated with sterile waterAlternate suctioning the channels with sterile water and airHand the endoscope and accessories to the circulator as soon as possible, so he/she may pre-clean (follow the steps on the next slide)
10 Cleaning and Decontamination Flexible endoscopes used in GI/Endoscopy Centers should be pre-cleaned in the Procedure Room wearing appropriate PPE and using the following recommended steps:External surface of insertion tube should be cleaned with a soft cloth or sponge and an enzymatic detergentInternal suction/biopsy channels cleaned by suctioning copious amounts of enzymatic detergent and airAir/water channels flushed with enzymatic solution, then flushed using low-pressure compressed air or a syringe if air is not availableComplex design components or channels should be flushed or purged with water and/or enzymatic detergent solution per the MFG’s IFUThe tip of the endoscope should be inspected for damage to any surface and any working part, and for cleanlinessThe video protective cap (if applicable) should be attached after removing the endoscope from the light source and suctionRemove all detachable parts and immerse in enzymatic detergent solution until transport.
11 Cleaning and Decontamination Flexible endoscopes are someof the most complex devicesfor health care workers to reprocess, due to their unique design and multiple reprocessing steps.Strict adherence to the scopeMFG’s validated instructions for use (IFU) is required.
12 Transport After pre-cleaning at point of use contaminated items should be immediately transported to the decontamination area before any remaining organic material dries on the surface, box lock, crevices or channels of the instruments.Surgical instruments should be covered with a wet towel or treated with an instrument cleaner prior to transport.Contaminated items can expose health care workers and can contaminate the environment during transportA sealed container should be used to avoid contaminating the environment or exposure to health care workersPer OSHA, the transport container must be labeled to indicate biohazardous contents.
13 Cleaning and Decontamination Meticulous cleaning and decontamination must proceed HLD or sterilizationMedical device manufacturers are required to provide healthcare facilities with validated reprocessing instructions for use (IFU)It is important to have and follow each device MFG’s IFU to ensure worker and patient safetyThis is especially true for complex devices with multiple pieces that have joints, crevices, lumens, ports and channelsProper PPE is required for all cleaning and decontamination steps.
14 Heat HLDPasteurization is a heat-automated HLD process that uses time and heat (i.e °F/ °C) for 30 minutes for HLD of heat-sensitive semi-critical devicesMedical washer/pasteurizers have wash, rinse and pasteurization cyclesSome pasteurizers offer quality assurance data recorders that document the temperature and cycle time
15 Chemical HLDFor chemical HLD, health care facilities must purchase FDA cleared HLD products as listed on the FDA websiteProducts selected should be compatible and efficacious with the materials or items to be disinfectedThe use of incompatible chemicals can damage the surfaces of the instrument, causing corrosion, scratches and other surface irregularitiesSuch damage can be a challenge for cleaning, HLD, interfere with proper function, and reduce the life and cosmetic appearance of the device
16 FDA-cleared Chemical sterilants and HLDs Device Type# of Registered ProductsChemical SterilizationHigh Level DisinfectionGlutaraldehyde17XHydrogen Peroxide4Ortho-phthaldehyde (OPA)3Peracetic Acid2Sodium Hypochlorite1Chemical Vapor w/FormaldehydeHydrogen Peroxide Gas PlasmaHydrogen Peroxide without PlasmaOzone GasSource:
17 Update with McKesson branded products Chemical HLDHLD requires appropriate temperature, contact time, and length of use following solution activationMFG’s IFU should be followed when preparing disinfectant solutions, calculating expirations dates, and labeling solution soaking containersUpdate with McKesson branded products
18 HLD and Steriliant requires no mixing or activation Chemical HLDGlutaraldehyde has been widely used for a long time in health care facilities as a HLD for reusable medical devicesMost solutions are acidic and must be activated to become sporicidal. There are a variety of brand names available in a variety of concentrations, with and without surfactantsHLD and Steriliant requires no mixing or activation
19 Chemical HLDOrtho-phthaladehyde (OPA) has demonstrated superior mycobactericidal activity compared to glutaraldehyde and requires no mixing or activationOPA has been shown to last longer before reaching its MEC and the concentration of the active ingredient does not decrease with age alone
20 Chemical HLDOther solutions FDA-cleared for HLD include hydrogen peroxide, peracetic acid and sodium hypochlorite in a variety of concentrations and combinationsThe FDA website has a listing of manufacturers, active ingredients and contact conditions for each cleared solution
21 Chemical HLDBecause most HLDs are reused, they must be tested and recorded prior to each use to assure that they remain above their MRCIf the test strip fails, the HLD solution should not be used, even if it’s within the reuse life
22 Reprocessing of Flexible Endoscopes Chemical HLD is recognized as the standard for the reprocessing of flexible gastrointestinal endoscopes by SGNA, ASGE, ACG, AGA, APIC and ASTThe CDC and The Joint Commission recognize HLD as appropriate for gastrointestinal endoscopes
23 Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes Are you following the updated 2012 SGNA Standards?23
24 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes After the necessary Pre-Cleaning, Leak Testing, Manual Cleaning and Rinsing steps; this SGNA Standard details both manual and AER HLD starting with Step 5
25 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5. Manual HLD:1. Completely immerse the endoscope and all removable parts in a basin of HLDa. The basin must be of a size to accommodate the endoscope without undue coiling, and must have a tight-fitting lid to contain the chemical vaporsb. To prevent damage, the endoscope should be not be soaked with other sharp instruments
26 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5. Manual HLD2. Flush disinfectant into all channels of the endoscope until it can be seen exiting the opposite end of each channel. Take care that all channels are filled with the chemical, and that no air pockets remain within the channelsComplete microbial destruction cannot occur unless all surfaces are in complete contact with the chemicalSince internal contact cannot be visually confirmed because of scope design, purging until a steady flow of solution observed is necessary.
27 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5A. Manual HLD:3. Cover the soaking basin with a tight-fitting lid to minimize chemical vapor exposureNote that:a. Exposure to chemical vapors may present a health hazardb. The reprocessing area should have engineering controls to ensure good air quality
28 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5A. Manual HLD:4. Soak the endoscope in the HLD solution for the time/temperature required to achieve HLD Use a timer to verify soaking time5. Purge all channels completely with air before removing the endoscope from the HLD solution. Note that purging the channels preserves the concentration and volume of the chemical, and prevents exposure from dripping and spilling
29 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5A. Manual HLD:6. RINSE (same as after Manual Cleaning)a. Thoroughly rinse the endoscope and all removable parts with clean water to remove residual debris and detergentb. Purge water from all channels using forced air. Dry the exterior of the endoscope with a soft, lint-free cloth to prevent dilution of the liquid chemical germicide used in subsequent steps
30 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying:a. Purge all channels with air until dryNote that:Bacteria such as Pseudomonas aeruginosa have been identified in both tap and filtered water, and may multiply in a moist environmentAvoid the use of excessively high air pressure which can damage the internal channels of flexible endoscopes
31 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying:Flush all channels, including accessory channels, with alcohol until the alcohol can be seen exiting the opposite end of each channel70% isopropyl alcohol is used to assist in drying the interior channel surfacesIt must be properly stored in a closed container between uses, because when exposed to air, it rapidly evaporates, and if less than recommended % level, cannot be relied upon to assist in the drying processAlcohol flushes should be used even when sterile water is used for rinsingPurge all channels with air. Note that alcohol mixes with the remaining water on the channel surfaces and acts to encourage evaporation of the residual water as air flows through the channelRemove all channel adaptersDry the exterior of the endoscope with a soft, clean lint-free towelThoroughly rinse and dry all removable parts. Do not attach removable parts (e.g. valves, etc.) to the endoscope during storage as this can trap liquid inside
32 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 7. Storage:Hang the endoscope in a vertical position to facilitate drying (with caps, valves, and other detachable components removed, per MFG’s IFU)a. The storage area should be clean, well ventilated and dust freeb. Correct storage will prevent damagec. The interval of storage before use has limited investigations and warrants further data
33 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes Automated HLD:Automated Endoscope Reprocessors (AERs) standardize the disinfection process and decrease personnel exposure to HLDsNOTE:It is necessary to follow all steps for the manual cleaning prior to using an AER.
34 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes Automated HLD:An AER should have the following features:Circulate fluids through all endoscope channels at an equal pressure without trapping air. Channel flow sensors provide an added measure of complianceDetergent and disinfectant cycles should be followed by thorough rinse cycles and forced air to remove all used solutionsDisinfectant should not be diluted with any fluidsMachine should be self-disinfectingNo residual water should remain in hoses and reservoirsCycles for alcohol flushing and forced air drying are desirableShould also feature a self-contained or external water filtration systemIn addition, a method to automatically store or print data verification of cycle completion, is desirable
35 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes To use an AER:1. Follow steps for manual cleaning of endoscope2. Prepare the AER according to the MFG’s guidelines3. Place the endoscope in the AER and attach all channel adapters according to the MFG’s IFUa. The elevator channel of a duodenoscope has a very small lumen. Since most AERs cannot generate pressure required to force fluid through the lumen, a 2-5 ml syringe must be used to manually reprocess (all steps) the elevator channel unless the AER is validated to perfuse this channel
36 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes To use an AER:Place valves and other removable parts into the soaking basin of the AER. Unless the AER has a dedicated space for accessories, reprocess these items separatelyIf the AER has a cycle that uses enzymatic detergent, it should be a product that is compatible with the AER and the endoscopeSet the AER for the appropriate time and temperature depending on the chemical usedStart the AER and allow it to complete all cycles or phasesNote that if cycles or phases are interrupted, HLD cannot be ensured and the full cycle must be repeated
37 To get a free copy of the complete SGNA document, go to: www.sgna.org SGNA Standards of Infection Control in Reprocessing of Flexible EndoscopesTo use an AER:If AER does not include a final alcohol rinse, this step should be done manually followed by purging all the channels with air until dry The ERCP elevator and elevator channel must be manually perfused and dried per MFG’s instructionsDrying and storage procedures are the same as described in the manual disinfection sectionTo get a free copy of the complete SGNA document, go to:
38 Chemical HLD SafetyHealthcare facilities are responsible for providing a safe work and patient care environmentPatients, visitors, and health care workers should be protected from injuries or illnesses caused by hazardous chemicalsWhen handling HLDs, personnel should wear protective apparel that may include, but is not limited to:100% nitrile rubber or 100% butyl rubber gloves when handling glutaraldehydePVC gloves should not be worn because they absorb glutaraldehydeProtective eye wear, face mask, and impervious gown
39 Chemical HLD SafetyGlutaraldehyde should only be used in well ventilated areas or in freestanding or vented chemical fume hoodsVapor generated from glutaraldehyde can may aggravate preexisting respiratory conditionsAAMI describes adequate ventilation as:Room large enough to ensure adequate dilution of vapors10 air exchanges per hourExhaust located at the source of the discharge of vaporsFresh air return at ceiling level across room from exhaust ventsRoutine maintenance and surveillance of systemElimination of cross draft effectsAir must not be recirculated
40 Chemical HLD SafetyGlutaraldehyde can be absorbed by inhalation, ingestion and through the skinIt has a detectable odor at 0.04 parts per million volume (ppmv) and is irritating to skin and mucous membranes at 0.3 ppmvVapors are released whenever solutions are disturbed and the surface tension is brokenmixing, adding and removing equipment, or disposing of a glutaraldehyde solution can cause a break in the surface tensionWhenever the glutaraldehyde solution is not being accessed, it should be covered with a tight-fitting lid
41 Chemical HLD SafetyGlutaraldehyde vapor monitoring is important per The American Conference of Governmental Industrial Hygienists (ACGIH) which recommends a ceiling limit of 0.05 ppm for occupational exposureOSHA has not established exposure limits; however, OSHA can regulate exposure and has recommended following the ACGIH limit
42 Chemical HLDTo avoid these glutaraldehyde issues, many health care facilities have switched to using an OPA for HLDMcKesson OPA/28 features:The fastest manual disinfection timeTwice the reuse period of other OPA brandsGuaranteed materials compatibility100% Satisfaction GuaranteeNEW
43 Update with McKesson branded product Chemical HLD SafetyExposure monitoring is not required; however, OPA is still a potential irritant of eyes, skin, nose and other tissues resulting in symptoms such as stinging, excessive tearing, coughing, and sneezingLike glutaraldehyde, OPA fixes proteins, allows for biofilm formation and exposure causes staining on linen, skin, instruments and AERsUpdate with McKesson branded product
44 Training and Education Personnel should receive initial training and competency validation on procedures, chemicals used, and PPE and should receive additional training when new equipment, instruments, supplies, or procedures are introducedEmployers must provide:Written hazard communication programHazard evaluationHazardous materials inventorySafety Data SheetsLabels on all containers of hazardous chemicalsEmployee training.
45 Quality Control Program A quality control program should be established in all areas where HLD is usedQuality control programs should be documented and should include, but not be limited to:Orientation programsCompetency assuranceContinuing educationQuality control checksInvestigation of adverse eventsMonitoring of solution replacement intervals
46 Quality Control Program Surfaces of complex instruments require meticulous cleaning in order to minimize infection control risks to patients and staffInadequate cleaning can potentially leave residual protein on a surfaceQuality control checks, such as ATP systems and VERiFIND™ Protein Detection Kit, provide rapid and easy to read cleaning verification
47 CONCLUSIONHealth care workers responsible for HLD must maintain the technical skills needed to establish and maintain a safe practice environment for patients, visitors and peersAdministrative personnel must ensure competency validation of personnel participating in decontamination and HLD of reusable medical devicesThe validation of competencies should include all types of devices the individual is authorized to reprocess
49 References & Resources Association for the Advancement of Medical Instrumentation. (2010). Chemical sterilization and high level disinfection in health care facilities (ANSI/AAMI ST58:2005/(R) 2010). Arlington, VA.Association of periOperative Registered Nurses. (2013 Edition). Recommended Practices for High-Level Disinfection.Society of Gastroenterology Nurses and Association, Inc. (2007) Guideline for High-Level Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes.Society of Gastroenterology Nurses and Association, Inc. (2012) Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes.Occupational Health and Safety Administration (OSHA). (2012). Hazardous waste and emergency response.Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee (HICPAC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities.49