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. 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 spores
Low-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 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

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 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)

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 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
Complex 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.

11. Cleaning and Decontamination
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. 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 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.

13. Cleaning and Decontamination
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.

14. Heat HLD
Pasteurization 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 devices
Medical washer/pasteurizers have wash, rinse and pasteurization cycles
Some pasteurizers offer quality assurance data recorders that document the temperature and cycle time

15. Chemical HLD
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

16. FDA-cleared Chemical sterilants and HLDs
Device Type
# of Registered Products
Chemical Sterilization
High Level Disinfection
Glutaraldehyde 17 X
Hydrogen Peroxide 4
Ortho-phthaldehyde (OPA) 3
Peracetic Acid 2
Sodium Hypochlorite 1
Chemical Vapor w/Formaldehyde
Hydrogen Peroxide Gas Plasma
Hydrogen Peroxide without Plasma
Ozone Gas
Source:

17. Update with McKesson branded products
Chemical HLD
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
Update with McKesson branded products

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

19. Chemical HLD
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

20. Chemical HLD
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

21. Chemical HLD
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

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? 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 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
Complete microbial destruction cannot occur unless all surfaces are in complete contact with the chemical
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:
Bacteria such as Pseudomonas aeruginosa have been identified in both tap and filtered water, and may multiply in a moist environment
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:
Flush all channels, including accessory channels, with alcohol until the alcohol can be seen exiting the opposite end of each channel
70% isopropyl alcohol is used to assist in drying the interior channel surfaces
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
Alcohol flushes should be used even when sterile water is used for rinsing
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
Remove all channel adapters
Dry the exterior of the endoscope with a soft, clean lint-free towel
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:
Circulate fluids through all endoscope channels at an equal pressure without trapping air. Channel flow sensors provide an added measure of compliance
Detergent and disinfectant cycles should be followed by thorough rinse cycles and forced air to remove all used solutions
Disinfectant should not be diluted with any fluids
Machine should be self-disinfecting
No residual water should remain in hoses and reservoirs
Cycles for alcohol flushing and forced air drying are desirable
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. 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 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

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 Endoscopes
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:

38. Chemical HLD Safety
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

39. Chemical HLD Safety
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

40. Chemical HLD Safety
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

41. Chemical HLD Safety
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

42. Chemical HLD
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
NEW

43. Update with McKesson branded product
Chemical HLD Safety
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
Update 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 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.

45. Quality 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 programs
Competency assurance
Continuing education
Quality control checks
Investigation of adverse events
Monitoring 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 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

47. CONCLUSION
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

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 or
© 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.
Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee (HICPAC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities. 49