Presentation is loading. Please wait.

Presentation is loading. Please wait.

Best Practices for High-Level Disinfection (HLD) Presented by Crosstex/SPSmedical Chuck Hughes, VP of Infection Prevention & Consulting.

Similar presentations


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 devices Understand the importance of effective cleaning and decontamination prior to HLD Identify commonly used agents for HLD Discuss 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 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

4 Spaulding 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

5 Spaulding 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 – Gastrointestinal endoscopes (and accessories)

6 Spaulding 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 is considered an effective barrier to most organisms Examples of non-critical items include, but are not limited to: – Tourniquets – Blood pressure cuffs – Linens – Bed pans – Stethoscopes

7 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. High-level disinfectants Intermediate-level disinfectants may kill mycobacteria, vegetative bacteria, most viruses, and most fungi but do not necessarily kill bacterial spores Intermediate-level disinfectants Low-level disinfectants may kill most vegetative bacteria, some fungi, and some viruses. Low-level disinfectants Three Levels of Disinfection

8 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 Cleaning and Decontamination

9 Flexible endoscopes used on the sterile field should be pre-cleaned to the following recommended steps: 1.Wipe external surfaces with a lint-free cloth saturated with sterile water 2.Alternate suctioning the channels with sterile water and air 3.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) Cleaning and Decontamination

10 Flexible endoscopes used in GI/Endoscopy Centers should be pre-cleaned in the Procedure Room wearing appropriate PPE and using the following recommended steps: 1.External surface of insertion tube should be cleaned with a soft cloth or sponge and an enzymatic detergent 2.Internal suction/biopsy channels cleaned by suctioning copious amounts of enzymatic detergent and air 3.Air/water channels flushed with enzymatic solution, then flushed using low-pressure compressed air or a syringe if air is not available 4.Complex design components or channels should be flushed or purged with water and/or enzymatic detergent solution per the MFG’s IFU 5.The tip of the endoscope should be inspected for damage to any surface and any working part, and for cleanliness 6.The video protective cap (if applicable) should be attached after removing the endoscope from the light source and suction 7.Remove all detachable parts and immerse in enzymatic detergent solution until transport. Cleaning and Decontamination

11 Flexible endoscopes are some of the most complex devices for health care workers to reprocess, due to their unique design and multiple reprocessing steps. Strict adherence to the scope MFG’s validated instructions for use (IFU) is required.

12 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 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. Transport

13 Meticulous cleaning and decontamination must proceed HLD or sterilization – Medical 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 safety – This is especially true for complex devices with multiple pieces that have joints, crevices, lumens, ports and channels – Proper PPE is required for all cleaning and decontamination steps. Cleaning and Decontamination

14 Pasteurization is a heat-automated HLD process that uses time and heat (i.e. 160-170°F/21.7-25°C) for 30 minutes for 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 Heat HLD

15 For chemical HLD, health care facilities must purchase FDA cleared HLD products as listed on the FDA website – Products selected 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 Chemical HLD

16 FDA-cleared Chemical sterilants and HLDs Device Type# of Registered Products Chemical Sterilization High Level Disinfection Glutaraldehyde17XX Hydrogen Peroxide4XX Ortho-phthaldehyde (OPA) 3X Peracetic Acid2XX Sodium Hypochlorite1X Chemical Vapor w/Formaldehyde 2X Hydrogen Peroxide Gas Plasma 1X Hydrogen Peroxide without Plasma 1X Ozone Gas1X Source: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.htm

17 HLD 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 Chemical HLD Update with McKesson branded products

18 Glutaraldehyde 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 Chemical HLD HLD and Steriliant requires no mixing or activation

19 Ortho-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 MEC and the concentration of the active ingredient does not decrease with age alone Chemical HLD

20 Other 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 Chemical HLD

21 Because most HLDs are reused, they must be tested and recorded prior to each use to assure that they remain above their MRC – If the test strip fails, the HLD solution should not be used, even if it’s within the reuse life Chemical HLD

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 AST The 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?

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 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

26 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 5. Manual HLD 2. 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 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.

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 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

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 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

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 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

30 SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes 6. Drying: a. Purge all channels with air until dry Note that: a.Bacteria such as Pseudomonas aeruginosa have been identified in both tap and filtered water, and may multiply in a moist environment b.Avoid 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: b) Flush all channels, including accessory channels, with alcohol until the alcohol can be seen exiting the opposite end of each channel a.70% isopropyl alcohol is used to assist in drying the interior channel surfaces b.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 c.Alcohol flushes should be used even when sterile water is used for rinsing 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 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

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 free b. Correct storage will prevent damage c. 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 HLDs NOTE : 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: 1.Circulate fluids through all endoscope channels at an equal pressure without trapping air. Channel flow sensors provide an added measure of compliance 2.Detergent and disinfectant cycles should be followed by thorough rinse cycles and forced air to remove all used solutions 3.Disinfectant should not be diluted with any fluids 4.Machine should be self-disinfecting 5.No residual water should remain in hoses and reservoirs 6.Cycles for alcohol flushing and forced air drying are desirable 7.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

35 SGNA 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

36 To use an AER: 4.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 5.If the AER has a cycle that uses enzymatic detergent, it should be a product that is compatible with the AER and the endoscope 6.Set the AER for the appropriate time and temperature depending on the chemical used 7.Start the AER and allow it to complete all cycles or phases 8.Note that if cycles or phases are interrupted, HLD cannot be ensured and the full cycle must be repeated SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes

37 To use an AER: 8.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 9.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: www.sgna.org SGNA Standards of Infection Control in Reprocessing of Flexible Endoscopes

38 Healthcare facilities are responsible for providing a safe work and patient care environment Patients, visitors, and health care workers should be protected from injuries or illnesses caused by hazardous chemicals 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 PVC gloves should not be worn because they absorb glutaraldehyde Protective eye wear, face mask, and impervious gown Chemical HLD Safety

39 Glutaraldehyde 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 Chemical HLD Safety

40 Glutaraldehyde 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 – mixing, adding and removing equipment, or disposing of a glutaraldehyde solution can cause a break in the surface tension – Whenever the glutaraldehyde solution is not being accessed, it should be covered with a tight-fitting lid Chemical HLD Safety

41 Glutaraldehyde 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 Chemical HLD Safety

42 To avoid these glutaraldehyde issues, many health care facilities have switched to using an OPA for HLD McKesson OPA/28 features: – The fastest manual disinfection time – Twice the reuse period of other OPA brands – Guaranteed materials compatibility – 100% Satisfaction Guarantee Chemical HLD NEW

43 Exposure 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 Chemical HLD Safety Update with McKesson branded product

44 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: – Written hazard communication program – Hazard evaluation – Hazardous materials inventory – Safety Data Sheets – Labels on all containers of hazardous chemicals – Employee training. Training and Education

45 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 programs Competency assurance Continuing education Quality control checks Investigation of adverse events Monitoring of solution replacement intervals Quality Control Program

46 Surfaces of complex instruments require meticulous cleaning in order to minimize infection control risks to patients and staff Inadequate cleaning can potentially leave residual protein on a surface Quality control checks, such as ATP systems and VERiFIND ™ Protein Detection Kit, provide rapid and easy to read cleaning verification Quality Control Program

47 Health care workers responsible for HLD must maintain the technical skills needed to establish and maintain a safe practice environment for patients, visitors and peers Administrative personnel must ensure competency validation of personnel participating in decontamination and HLD of reusable medical devices The validation of competencies should include all types of devices the individual is authorized to reprocess CONCLUSION

48 Sponsored by McKesson website: www.SPSmedical.com Educational Program was presented by SPSmedical Supply Corp. To request 1 CE through IAHCSMM, CBPSD or California Board of Registered Nurses (CBRN), please contact SPSmedical at 800-722-1529 or education@spsmedical.comeducation@spsmedical.com © 2013, SPSmedical Supply Corp.

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. www.osha.gov Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee (HICPAC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities.


Download ppt "Best Practices for High-Level Disinfection (HLD) Presented by Crosstex/SPSmedical Chuck Hughes, VP of Infection Prevention & Consulting."

Similar presentations


Ads by Google