2Objectives At the end of this program, participants will be able to: explain the Spaulding classification system for the reprocessing of reusable medical devices,understand the importance of effective cleaning of reusable medical devices prior to HLD,identify commonly used agents for HLD,discuss SGNA recommended steps for the HLD of flexible gastrointestinal endoscopes.
3Spaulding Classification System In 1968, Dr. Earle Spaulding devised a rational approach to disinfection and sterilization that is still in use today. He believed that instruments and equipment should be reprocessed according to the nature of the item and the level of risk associated with their intended use.This is referred to as Spaulding's classification system and it has been refined and retained over the years, because it is so clear and logical. The three (3) categories he described were critical, semi-critical and non-critical.
4Spaulding Classification System Critical items are medical devices that enter sterile tissue or the vascular system. These items should be sterile when used. Examples include, but are not limited to: surgical instruments, cutting endoscopic accessories that break the mucosal barrier, endoscopes used in sterile body cavities, cardiac, vascular or urinary catheters, implants, needles and ultrasound probes used in the sterile body cavities.
5Spaulding Classification System Semi-critical items are medical devices that come into contact with non-intact skin or mucous membranes. These items should be high level disinfected when used. Examples include, but are not limited to: vaginal and rectal probes, anesthesia equipment, laryngoscopes, bronchoscopes and gastrointestinal endoscopes and accessories.
6Spaulding Classification System Non-critical items are medical devices that come into contact with only intact skin. These items should receive intermediate level disinfection, low-level disinfection or cleaning. Intact skin acts is considered an effective barrier to most organisms. Examples of non-critical item include, but are not limited to: tourniquets and blood pressure cuffs, linens, bed pans and stethoscopes.
7Three 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.
8BEST PRACTICESIn the U.S., high-level disinfection best practices are detailed in AAMI Standards, the AORN Perioperative Standards and Recommended Practices, along with other documents, such as SGNA which focuses on flexible gastrointestinal endoscopes.8
9HLD starts at POU!Pre-cleaning must occur at point of use in order to keep blood and other organic material from drying. Blood and body fluids, as well as saline, are highly corrosive and can damage instruments. Dried blood and debris is difficult, if not impossible to clean during decontamination, which can cause disinfection (or sterilization) not to be achieved.Surgical instruments should be wiped as needed with sterile surgical sponges moistened with sterile water during the procedure to remove gross soil. Instruments with lumens should be irrigated with sterile water.
10Pre-Cleaning at POUFlexible 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 water.Alternate suctioning the channels with sterile water and air.Hand the endoscope and accessories to the circulator as soon as possible, so he/she may pre-clean (follow the steps on the next slide).
11Pre-Cleaning at POUFlexible 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 detergent.Internal suction/biopsy channels cleaned by suctioning copious amounts of enzymatic detergent and air.Air/water channels flushed with enzymatic solution, then flushed using low-pressure compressed air or a syringe if air is not available.
12Pre-Cleaning at POUComplex design components or channels should be flushed or purged with water and/or enzymatic detergent solution per the MFG’s IFU.The tip of the endoscope should be inspected for damage to any surface and any working part, and for cleanliness.The video protective cap (if applicable) should be attached after removing the endoscope from the light source and suction.Remove all detachable parts and immerse in enzymatic detergent solution until transport.
13TransportAfter 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 healthcare workers and can contaminate the environment during transport. A sealed container should be used to avoid contaminating the environment or exposure to health care workers. Per OSHA, the transport container must be labeled to indicate biohazardous contents.
14Cleaning and RinsingMeticulous cleaning and rinsing must proceed HLD or sterilization of reusable medical devices in accordance with the device MFG’s validated IFU. It is best practice for healthcare facilities to secure and review the IFU prior to purchase, trial or borrowing a device to ensure they have the necessary resources to comply with the IFU.Special Note: Never clean in a sink that is used for hand washing. Be sure to wear PPE, such as face shield, face mask, fluid repellant gown with sleeves and utility gloves to protect yourself. Pay close attention to the quality of the water specified in the IFU, especially for rinsing.
15Drying and InspectionAfter devices are rinsed they can be dried with a lint free cloth, air and an alcohol flush when cleaning flexible endoscopes.Visual inspection is important as soil or detergent residues, lint from cloths, as well as minerals found in hard water can affect the efficacy of the HLD solution. To verify the effectiveness of the cleaning process, consider using an external quality control check, such as ATP systems or the VERiFIND™ Protein Detection Kit.
16Heat HLDPasteurization is a heat-automated HLD process that uses time and heat (i.e °F/ °C) for 30 minutes to achieve HLD of heat-sensitive semi-critical devices. Medical washer/pasteurizers have wash, rinse and pasteurization cycles. Some pasteurizers offer quality assurance data recorders that document the temperature and cycle time.
17Chemical HLDFor chemical HLD, healthcare facilities must purchase an FDA cleared HLD product as listed on the FDA website. Product selection should be compatible and efficacious with the materials or items to be disinfected.The use of incompatible chemicals can damage the surfaces of the instrument, causing corrosion, scratches and other surface irregularities. Such damage can be a challenge for cleaning, HLD, interfere with proper function, and reduce the life and cosmetic appearance of the device.
18FDA-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:
19Chemical HLDHLD requires appropriate temperature, contact time, and length of use following solution activation. MFG’s IFU should be followed when preparing disinfectant solutions, calculating expirations dates, and labeling solution soaking containers.
20HLD 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 devices. Most 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 surfactants.HLD and Steriliant requires no mixing or activation
21HLD and Steriliant requires no mixing or activation Special Note:For solutions that require mixing or activation, it is critical to follow the MFG’s written IFU concerning water quality. Some HLDs may require treated water and if a water treatment process is used, it should be monitored to ensure that the appropriate quality of water is achieved.HLD and Steriliant requires no mixing or activation
22Chemical HLDOrtho-phthaladehyde (OPA) has demonstrated superior mycobactericidal activity compared to glutaraldehyde and requires no mixing or activation. OPA has been shown to last longer before reaching its MRC and the concentration of the active ingredient does not decrease with age alone.
23Chemical HLDOther solutions FDA-cleared for HLD include, hydrogen peroxide, peracetic acid and sodium hypochlorite in a variety of concentrations and combinations. The FDA website has a listing of manufacturers, active ingredients and contact conditions for each cleared solution.
24General Safety Considerations Healthcare personnel must be advised of the hazards associated with chemicals, such as HLDs and trained in appropriate safety procedures. OSHA requires healthcare facilities to maintain the SDSs for all hazardous chemicals and be readily available to personnel working in the area.When 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 glutaraldehyde. Note: PVC gloves should not be worn because they absorb glutaraldehyde.Protective eye wear, face mask, and impervious gown.
25Chemical HLD SafetyGlutaraldehyde should only be used in well ventilated areas or in freestanding or vented chemical fume hoods. Vapor generated from glutaraldehyde can may aggravate preexisting respiratory conditions.AAMI describes adequate ventilation as:Room large enough to ensure adequate dilution of vapors.10 air exchanges per hour.Exhaust located at the source of the discharge of vapors.Fresh air return at ceiling level across room from exhaust vents.Routine maintenance and surveillance of system.Elimination of cross draft effects.Air must not be recirculated.
26Chemical HLD SafetyGlutaraldehyde can be absorbed by inhalation, ingestion and through the skin. It has a detectable odor at 0.04 parts per million volume (ppmv) and is irritating to skin and mucous membranes at 0.3 ppmv.Vapors are released whenever solutions are disturbed and the surface tension is broken, such as mixing, adding and removing equipment, or disposing of a glutaraldehyde solution can cause a break in the surface tension. Always cover the solution with a tight-fitting lid.
27Chemical 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 exposure.OSHA has not established exposure limits; however, OSHA can regulate exposure and has recommended following the ACGIH limit.
28Chemical HLDTo avoid these glutaraldehyde issues, many health care facilities have switched to using an OPA for HLD. The recently introduced Rapicide® OPA/28 features the fastest disinfection time, twice the reuse period of other OPA brands and guaranteed materials compatibility.
29Chemical 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 sneezing. Like glutaraldehyde, OPA fixes proteins, allows for biofilm formation and exposure causes staining on linen, skin, instruments and AERs.
30Training 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 introduced.Employers must provide a written hazard communication program, hazard evaluation, hazardous materials inventory, Safety Data Sheets, labels on all containers of hazardous chemicals, and employee training.
31Quality Control Program A quality control program should be established in all areas where HLD is used. Quality 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
32Quality Control - Manual Processes Because most HLDs are reused, they must be tested and recorded prior to each use to assure that they remain above their MRC. Solution test strips must be FDA cleared and used in accordance with the MFG’s IFU. If the test strip fails, the HLD solution should not be used, even if it’s within the reuse life.
33Quality Control - Automated Equipment In addition to the solution test strip, users of automated equipment (AE), should check the printout at the start of each cycle to verify that the cycle ID number has been recorded and that the printer is functioning. At the end of each cycle, the operator should examine the printout and verify the cycle parameters were met and initial it to allow later ID of the operator.Special Note: AE that do not have printers should not be used. With the exception of one proprietary AE that uses peracetic acid, spore test strips or BIs are not available for HLD processes.
34QC Training & Recordkeeping Healthcare personnel must be trained for proper use and interpretation of solution test strips. Meticulous records must be kept for both the HLD solution and the test strips.
35It is important to know… All national survey organizations now audit healthcarefacilities for strict compliance with standards, guidelines,and MFG’s instructions for use (IFU).
36The Centers for Medicare & Medicaid Services (CMS) has revised their Survey and Certification documentin 2009 to include more stringent audits in the areasof infection control and sterilization.Areas of emphasis include:Compliance with nationally recognized standards/documents.Formal training in areas of infection control and sterilization.Compliant cleaning, sterilization and monitoring procedures.Established criteria for flash sterilization.Reference:CMS Infection Control Surveyor Worksheet, Exhibit 351, 2009.3636
37In 2010, the Accreditation Association for Ambulatory Healthcare (AAAHC) added an infection control chapterto their standards handbook.Infection control highlights included:“Adhering to standards, guidelines, and manufacturer’sinstructions for cleaning, disinfection, and sterilizationof instruments, equipment, supplies, and implants.”Reference:OR Manager Magazine, Volume 26, Number 2, 20103737
38In 2011, Joint Commission surveyors received in-depth training on sterilization processes. This education wasprovided in collaboration with AAMI and included areview of all aspects of the AAMI ST79 guideline onsteam sterilization. Thereafter, a similar educationalModule was delivered on HLD of endoscopes.July 20, Joint Commission OnlineFocus on sterilization and high-level disinfection processes3838
39HLD of Endoscopes Flexible endoscopes are some of the most complex devicesfor HCWs to reprocess due totheir unique design and multiplereprocessing steps.Unfortunately, non-compliancewith MFG’s IFUs has led to anumber of bad outcomes andunwanted media attention.EXAMPLES:Ottawa Public Health issued letters to 6,800 patients warning they may have been exposed to hepatitis B, hepatitis C or HIV after being treated with dirty endoscope. (Oct, 2011)PA hospital found negligent last year for having improperly cleaned and HLD endoscopes used in 2004 and (July, 2012)Quebec hospital failed to properly reprocess an endoscope for past 8 years and asks 1,000 patients to come in for HIV, hepatitis B and C testing. (June, 2013)The head of the Brant Community Healthcare System issued an apology to patient who was infected with hepatitis C during an endoscopy. (Jan, 2014)
40January 6, 2014 The Chicago Sun-Times reported the largest outbreak of a superbug– “CRE” in U.S. history, has beenconfirmed at a hospital outside ofChicago, IL.The hospital – Advocate Lutheran General – linked these critical patient infections of CRE (Carbapenem-Resistant Enterobacteriaceae) to an ERCP (endoscopic retrograde cholangiopancreatography) procedure that uses fluoroscopy and an ERCP endoscope (or, duodenoscope).
41Largest outbreak of dangerous bacteria Between January and September of 2013, 243 patients who had undergone ERCP were notified by the hospital of their increased risk of CRE infection. Of the 114 patients who were tested, 38 were either infected or colonized with CRE, with 28 not displaying symptoms of infection. Unfortunately, 10 patients infected, some them critically, has infections of the blood, urine or in wounds.This outbreak involving 38 patients (16% of the total that underwent ECRP) is especially concerning because CRE has a mortality rate as high as 50%.
42Largest outbreak of dangerous bacteria The CDC reported that a likely contributing factor to this “superbug” outbreak at Advocate Lutheran General Hospital (Park Ridge, IL) was the improper automated cleaning and/or disinfection of the implicated ERCP endoscopes.The CDC reported that previous studies have shown an association between ERCP endoscopes and transmission of multidrug resistant bacteria; the design of the ERCP endoscopes might pose a particular challenge for cleaning and disinfection.
43January 22, 2014SEATTLE -- A breakdown in training left instruments dirty and opened the doors to dangerous infections for more than 100 patients at Seattle Children's Hospital.. In November, a technician discovered a poorly cleaned colonoscope. Another turned up a few days later. The scope's manufacturer spells out multi-step cleaning instructions to avoid cross-contaminating patients. Dr. Zerr says hospital procedures came up short on those requirements.Doctors say so far nobody has gotten sick, but the errors launched a State Health Department investigation.
44Reprocessing Flexible Endoscopes Chemical HLD is recognized as the standard for the reprocessing of flexible gastrointestinal endoscopes by SGNA, ASGE, ACG, AGA, APIC and AST. Also, the CDC and The Joint Commission recognize HLD as appropriate for gastrointestinal endoscopes.
45Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes SGNA document was updated in 201245
46Let’s review the HLD section… 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.
47SGNA 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 HLD.a. 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 vapors.b. To prevent damage, the endoscope should be not be soaked with other sharp instruments.
48SGNA 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 channels.
49SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5A. Manual HLD:a. Complete microbial destruction cannot occur unless all surfaces are in complete contact with the chemical.b. Since internal contact cannot be visually confirmed because of scope design, purging until a steady flow of solution observed is necessary.
50SGNA 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 exposure.Note that:a. Exposure to chemical vapors may present a health hazard.b. The reprocessing area should have engineering controls to ensure good air quality.
51SGNA 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 time.5. 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.
52SGNA 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 detergent.b. 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.
53SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying:a. Purge all channels with air until dry.Note that:1) Bacteria such as Pseudomonas aeruginosa have been identified in both tap and filtered water, and may multiply in a moist environment.2) Avoid the use of excessively high air pressure which can damage the internal channels of flexible endoscopes.
54SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying:b. Flush all channels, including accessory channels, with alcohol until the alcohol can be seen exiting the opposite end of each channel.1) 70% isopropyl alcohol is used to assist in drying the interior channel surfaces.2) It 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 process.3) Alcohol flushes should be used even when sterile water is used for rinsing.
55SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying:c. Purge 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 channel.d. Remove all channel adapters.
56SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying:e. Dry the exterior of the endoscope with a soft, clean lint-free towel.f. Thoroughly 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.
57SGNA 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 free.b. Correct storage will prevent damage.c. The interval of storage before use has limited investigations and warrants further data.
58SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes Automated HLD:Automated Endoscope Reprocessors (AERs) standardize the disinfection process and decrease personnel exposure to HLDs.NOTE:It is necessary to follow all steps for the manual cleaning prior to using an AER.
59SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes Automated HLD:An AER should have the following features:a. Circulate fluids through all endoscope channels at an equal pressure without trapping air. Channel flow sensors provide an added measure of compliance.b. Detergent and disinfectant cycles should be followed by thorough rinse cycles and forced air to remove all used solutions.c. Disinfectant should not be diluted with any fluids.
60SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes An AER should have the following features:d. Machine should be self-disinfecting.e. No residual water should remain in hoses and reservoirs.f. Cycles for alcohol flushing and forced air drying are desirable.g. Should also feature a self-contained or external water filtration system.In addition, a method to automatically store or print data verification of cycle completion, is desirable.
61SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes To use an AER:1. Follow steps for manual cleaning of endoscope.2. Prepare the AER according to the MFG’s guidelines.3. Place the endoscope in the AER and attach all channel adapters according to the MFG’s IFU.a. 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.
62To 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 separately.If the AER has a cycle that uses enzymatic detergent, it should be a product that is compatible with the AER and the endoscope.Set the AER for the appropriate time and temperature depending on the chemical used.Start the AER and allow it to complete all cycles or phases. Note that if cycles or phases are interrupted, HLD cannot be ensured and the full cycle must be repeated.
63To get a free copy of the complete SGNA document, go to: www.sgna.org To 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 instructions.Drying and storage procedures are the same as described in the manual disinfection section.To get a free copy of the complete SGNA document, go to:
64CONCLUSIONBest practice compliance is critical for patient, visitor and employee safety when working with HLD. Due to the complex nature of reprocessing, the ECRI Institute has listed improperly reprocessed endoscopes/surgical instruments as a top 10 health hazard for I trust this program will assist you in your goal of compliance with Best Practices for HLD!
66References & Resources American Conference of Governmental Industrial Hygienists, 1330 Kemper Meadow Drive, Cincinnati, OH ,Association for the Advancement of Medical Instrumentation. (2013). Chemical sterilization and high level disinfection in health care facilities (ANSI/AAMI ST58:2013). Arlington, VA.Association of periOperative Registered Nurses. (2013 Edition). Recommended Practices for High-Level Disinfection. Denver, CO.ECRI Institute. ECRI Releases Top 10 Health Technology Hazards for November 4, Plymouth Meeting, PA.Occupational Health and Safety Administration (OSHA). (2012). Hazardous waste and emergency response.Society of Gastroenterology Nurses and Association, Inc. (2012) Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes.66