1. High-Level Disinfection Record Keeping
August 12, 2015
Crosstex/SPSmedical Continuing Education Webinar

2. Objectives At the end of this program, participants will be able to:
explain the Spaulding classification system for the disinfection and sterilization of reusable medical devices,
identify commonly used agents for high-level disinfection (HLD) of reusable medical devices and general safety considerations,
discuss proper record keeping for HLD of reusable medical devices and the solution test strips which verify minimum recommended concentrations. 2

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 categories he described were critical, semi-critical and non-critical.
Speaker notes 3

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. 4

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 and gastrointestinal endoscopes and accessories. 5

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 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. 6

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. 7

8. Chemical HLD
For 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. 8

9. 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: 9

10. 28 day reuse period, 25 minute HLD and 10 hour sterilization at 25°C
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.
NEW
28 day reuse period, 25 minute HLD and 10 hour sterilization at 25°C 10

11. Chemical HLD
For solutions that require mixing or activation, it is critical to follow the MFR’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.
Activation required
No activation required 11

12. 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 MRC and the concentration of the active ingredient does not decrease with age alone. 12

13. 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. 13

14. Record Keeping
Documentation and record keeping is an important aspect of healthcare practice. Regardless of the type of HLD process used, certain records must be kept, including the following:
• The date of processing
• The results of MRC/MEC testing
• A description of the item being processed
• Confirmation that the item was cleaned before disinfection
• The temperature of the solution
• The time at which the item was immersed in the solution
• The time at which the item was removed from the solution
• The name or other identifier of the person who performed the
process. 14

15. Record Keeping
Records related to high-level disinfection should be retained for the period of time specified by the facility or the appropriate regulatory body for the retention of such records. The requirements of a regulatory body take precedence over the policy of the facility if the regulatory body’s requirements are more stringent.
There should be full traceability to the patient. 15

16. Record Keeping
Personnel should receive initial training and competency validation on procedures, chemicals used, and PPE along with 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.
*All training should be documented. 16

17. Chemical HLD
HLD requires appropriate temperature, contact time, and length of use following solution activation. MFR’s IFU should be followed when preparing disinfectant solutions, calculating expirations dates, and labeling solution soaking containers. 17

18. General Safety Considerations
All healthcare personnel must be advised of the hazards associated with chemicals, such as HLDs and thoroughly trained in appropriate safety procedures.
OSHA requires healthcare facilities to maintain the SDS (formerly referred to as MSDS) for hazardous chemicals and be readily available to personnel working in the area.
Healthcare personnel should wear appropriate PPE and avoid direct contact with hazardous chemicals. Solutions should be used in a well ventilated room and always kept covered to prevent inhalation to the fumes. 18

19. General Safety Considerations
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. 19

20. General Safety Considerations
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. 20

21. General Safety Considerations
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, such as 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. 21

22. General Safety Considerations
Glutaraldehyde vapor monitoring and record keeping 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. OSHA has a free document titled “Best Practices for the Safe Use of Glutaraldehyde in Health Care” which can be found at: 22

23. Chemical HLD
To avoid these glutaraldehyde issues, many health care facilities have switched to using an OPA HLD solution for their manual and/or automated processes. Over the years, Cidex OPA has become the market leader offering users a 12 min manual soak HLD time and 5 min HLD for AERs.
Because the reuse life is only 14 days, it is significantly more expensive than day glutaraldehyde HLD solutions Note: Only Cidex OPA solution test strips can be used to monitor Cidex OPA before each use. 23

24. CIDEX® OPA “How To Use” poster24

25. HLD Test Strip Record Keeping
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 MFR’s IFU. If the test strip fails, the HLD solution should not be used, even if it’s within the reuse life. 25

26. CIDEX® OPA Test Strip IFU
Source: ASP insert LC Rev. F
Reagents/Storage
The reagent pad at the end of the test strip is composed of paper impregnated with two reactive agents, sodium sulfite and pH-sensitive dye. Store CIDEX OPA Solution Test Strips in the original bottle with the cap tightly closed. Store at controlled room temperature, 15°-30°C (59°-86°F), and in a dry place. The shelf life (expiration date) for the unopened CIDEX OPA Solution Test Strips is stamped on the immediate container label. When opening the bottle for the first time, record the date opened in the space provided on the label. 26

27. CIDEX® OPA Test Strip IFU
1. Ensure that the solution to be tested has been dispensed according to labeling instructions.
2. Always note the date the bottle was opened and the “do not use after” date in the space provided on the bottle.
3. Ensure that appropriate safety precautions are observed
when testing CIDEX OPA Solution, refer to product
labeling and the Material Safety Data Sheet for CIDEX
OPA Solution.
4. Remove one Test Strip from the bottle and replace the
bottle cap immediately 27

28. CIDEX® OPA Test Strip IFU
5. Use a watch or timer to monitor the following steps.
6. Timing control is critical to accurate reading.
7. Completely Submerge indicating pad at the end of the
test strip into the container of the solution being tested.
Hold for one second and remove. Do not leave the strip in the test solution for longer than one second or “stir” the test strip in the solution. Incorrect dipping technique, such as swirling the test strip vigorously in the solution, will wash off the reagents in the test strip pad.
This can cause a lack of purple color formation (FAIL) when testing a solution that will normally test as PASS. 28

29. CIDEX® OPA Test Strip IFU
8. Remove excess solution from the indicating pad by standing the strip upright on a paper towel. Do not shake the strip after removal. When removing excess solution, incorrect technique, such as violently shaking the test strip and/or blotting the test strip with the pad face down against a paper towel, can remove the reagents and solution. This can cause FAIL results for solutions that will normally test as PASS.
9. Read the results of the color reaction present on the indicating pad at 90 seconds after the test strip is removed from the solution. If read in less than 90 seconds, the color change may be incomplete and may be interpreted incorrectly. If read past 90 seconds, color will gradually change to indicate “FAIL”. 29

30. CIDEX® OPA Test Strip IFU
To indicate an effective concentration of the solution, the indicating pad will be completely purple. Any shade of purple is acceptable; the intensity will vary due to concentration variation. If any blue appears on the indicating pad apart from the top line, the solution is below the MEC of 0.3% and should be discarded. Refer to the color chart on the test strip bottle for interpretation of test results. Record the result of the test in a suitable log book. See Section I, Test Results Interpretation, for additional important information on the use of this product.
10. Dispose of the used Test Strip in a waste bin or per hospital policy. 30

31. CIDEX® OPA Test Strip IFU
The following materials are not provided with the CIDEX OPA Solution Test Strips but will be needed for the test:
• watch or timer
• paper towel
• a clean polyethylene or polypropylene container will be required to hold the solution sample if the solution cannot be tested directly in the tray, bucket or container in which it is being held. 31

32. CIDEX® OPA Control Strip IFU
1. Preparation of Control Solutions
To prepare positive and negative control solutions for testing, first verify that the labeled expiration date for the solution is appropriate. This solution may be used as a positive control. To prepare a negative control, dilute one part of full strength solution with one part of water. Label each control solution appropriately. 32

33. CIDEX® OPA Control Strip IFU
2. Testing Procedure
Following the Directions for Use, submerge three test strips in each of the above freshly prepared solutions for one second each. Remove. The three strips dipped in the full strength positive control solution should exhibit a complete purple color on the indicating pad at 90 seconds. The three strips dipped in the diluted negative control should either remain completely blue or exhibit an incomplete color change to purple when read at 90 seconds. Refer to the color chart on the test strip bottle for interpretation of results. 33

34. CIDEX® OPA Control Strip IFU
3. Testing Frequency
It is recommended that the testing of positive and negative controls be performed on each newly opened test strip bottle of CIDEX OPA Solution Test Strips. After this initial testing, it is recommended that testing of freshly prepared positive and negative controls be performed on a regular basis as established by your own quality control procedures and program. This testing program will serve to minimize errors between different users, use of outdated materials or product that has been improperly stored or handled. 34

35. CIDEX® OPA Control Strip IFU
4. Unsatisfactory QC Test Performance
If the results obtained from using the positive and negative controls indicate the test strip is not functioning properly, discard the remaining strips. Do Not Use Strips. 35

36. Chemical HLD
In recent years, Rapicide® OPA/28 was introduced by Cantel Medical (sold in the U.S. by Crosstex/SPSmedical and outside the U.S. by Medivators). The new Rapicide® OPA solution features a faster manual HLD soak time and twice the reuse period of Cidex OPA. 36

37. RapiCide® OPA/28
“How To Use” Poster
Free CE program 37

38. Rapicide® OPA/28 HLD Solution
Rapicide OPA/28 High-Level Disinfectant is a neutral pH, legally marketed FDA 510(k) cleared, 28-day reusable high-level disinfectant. Cantel Medical has conducted extensive testing to ensure compatibility of Rapicide® OPA/28 High-Level Disinfectant (HLD) with medical endoscopes, automated endoscope reprocessors (AER), and all other common materials for which the use of ortho-Phthalaldehyde is indicated. To date, there have not been any reported compatibility issues. Cantel Medical is confident, based on the similarity of active ingredients and pH levels of Rapicide OPA/28 and other commercially marketed ortho-Phthalaldehyde products that the compatibility profile of Rapicide OPA/28 is comparable to that of the CIDEX® brand of OPA for all similarly labeled applications. 38

39. Rapicide® OPA/28 Test Strips
Note: Only Rapicide OPA/28 Solution test strip can be used to verify MRC before each use.
3 versus 1 second dip time.
Interpret result at 90 seconds
Color comparison chart on bottle
Green vs Purple = PASS
Shelf-life of test strips:
18 months unopened
6 vs 3 months opened
* Website has Control test strips certification! 39

40. Rapicide® OPA/28 HLD Solution
Date and initial the Rapicide OPA/28 bottle when first opened. Expiration date of solution is 75 days after the bottle is first opened, as long as the 75 days does not extend past the expiration date on the container.
Read the directions for use on the bottle label and package insert. For manual disinfection, wearing proper PPE pour Rapicide OPA/28 solution into a tray or appropriate container.
Record the date that the solution was poured from the original container and the date that it can be reused, not to exceed 28 days. 40

41. Future Date Calculator www.OPA28.com 41

42. Record Keeping
Health care 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. 42

43. Record Keeping
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.
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. 43

44. Flexible Endoscope Reprocessing Pocket Guide
According to SGNA, flexible endoscope reprocessing records should include, but are not limited to:
Date
Time
Endoscope identification
Method of cleaning
Name of person who performed the cleaning
HLD solution test strip quality control and MRC test results
Routine and unscheduled maintenance or repairs
Disposition of defective equipment
Personnel training and competency in the use, care and processing of flexible endoscopes and related equipment periodically, and before new endoscopic equipment and/or accessories are introduced into the practice
Flexible Endoscope Reprocessing Pocket Guide 44

45. Quality Control Program
SGNA also recommends that a quality control program be established in all areas where HLD is used. The quality control program should be documented and include, but not be limited to:
Orientation programs
Competency assurance
Continuing education
Quality control checks
Investigation of adverse events
Monitoring of solution replacement intervals 45

46. CONCLUSION
Record keeping is an essential part of health care and reprocessing facilities must keep records for each HLD use. If you are using paper-based records, they must be clearly written and easy to read, and you should sign and date all entries.
It is important that health care facilities protect records from being lost, damaged, accessed by someone without appropriate authority, or tampered with. The length of time these records should be kept is determined by each facility in accordance with local, state and/or national requirements. 46

47. Thank You! Chuck Hughes VP, Infection Prevention Consulting Services
SPSmedical Supply Corp. now part of Crosstex International
6789 W. Henrietta Road · Rush, NY USA
(800) ·
Certified as a Health Education teacher, Chuck has worked for over 25 years in the
manufacturing industry in areas of Regulatory Affairs, R&D, Marketing, Microbiology
and Sterilization Training. He is a corporate member AORN, AST, IAHCSMM, SGNA
and numerous other organizations, including AAMI and CSA where he contributes to
sterilization standards. A popular speaker at regional, national and international
healthcare conferences, Chuck has visited thousands of healthcare facilities during
his career providing sterilization consulting services that include fee based and
complementary audits of instrument reprocessing areas.
© 2015, SPSmedical Supply Corp. 47

48. References & Resources
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. (2015 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). (2006). Best Practices for the Safe Use of Glutaraldehyde in Health Care.
Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee (HICPAC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities. 48 48