1. Tracing High-Level Disinfection April 26, 2019
Mary Cole, MSN, CJCP, CIC
Consultant
Joint Commission Resources, Inc.

2. Publications and Record Restrictions
Copyright © 2019 by Joint Commission Resources, Inc. All rights reserved. No part of this publication may be reproduced in any form or by any means without written permission from the publisher. Request for permission to make copies of any part of this work should be addressed to However, the use of these materials for commercial purposes is restricted to JCR and may not be used by any other party or entity.

3. IC.02.02.01 Medical Equipment, Devices, and Supplies
The hospital reduces the risk of infections associated with medical equipment, devices, and supplies – implements infection prevention and control activities

4. IC.02.02.01 Medical Equipment, Devices, and Supplies
Low level disinfection
Intermediate and high level disinfection and sterilization
Disposal
Storage
Reprocessing single-use devices

5. Spaulding Classification

6. #1 most frequently cited clinical standard
#1 issue in Immediate Threat to Life

7. IC.02.02.01 Medical Equipment, Devices, and Supplies
EP2
Intermediate and high-level disinfection (HLD) and sterilization of medical equipment, devices and supplies, such as scopes; contamination issues

8. Know Where HLD Occurs Clinics Emergency Rooms OB-GYN Clinics ORs
Central Sterile Processing
Special Procedure Rooms
Sleep Apnea Study Labs
Endoscopy Rooms

9. HLD – Other Devices, Equipment
Vaginal and rectal probes, TEE probes
(Transesophageal echocardiography)
Respiratory therapy equipment
(CPAP masks/Sleep Study Centers)

10. Sleep Study Centers Masks Tubing, supplies Instructions for use
Reprocessing

11. Include HLD in Risk Assessment

12. Compliance Strategies
Approach to IC-related standards:
Regulation
Condition of participation (if deemed status)
Manufacturer instructions
Evidence-based standards or guidelines
Consensus documents or position papers
Incorporate into facility-based risk assessment and policy

13. Common Products For HLD
Glutaraldehyde
Ortho-phthalaldehyde (OPA)
Hydrogen peroxide

14. Glutaraldehyde Advantages
Numerous use studies published
Relatively inexpensive
Excellent material compatibility

15. Glutaraldehyde Disadvantages
Respiratory irritation from glutaraldehyde vapor
Pungent and irritating odor
Relatively slow mycobactericidal activity (unless other disinfectants added such as phenolic, alcohol)
Coagulates blood and fixes tissue to surfaces
Allergic contact dermatitis

16. OPA Advantages Fast acting, high-level disinfectant
No activation required
Odor not significant
Excellent materials compatibility claimed
Does not coagulate blood or fix tissues to surfaces claimed

17. OPA Disadvantages
Stains protein gray (e.g., skin, mucous membranes, clothing, environmental surfaces)
Limited clinical experience
More expensive than glutaraldehyde
Eye irritation with contact
Slow sporicidal activity
Anaphylactic reactions to OPA in bladder cancer patients with repeated exposure to OPA through cystoscopy

18. Hydrogen Peroxide Advantages
No activation required
No odor
Non-staining
No special venting requirements
Manual or automated applications
12-month shelf life, 14-day reuse
8 min at 20oC high-level disinfectant claim

19. Hydrogen Peroxide Disadvantages
Material compatibility concerns (brass, zinc, copper and nickel/silver plating) both cosmetic and functional
Severely irritating and corrosive to eyes, skin and gastrointestinal tract if inadequately rinsed
Excessive exposure could cause irreversible tissue damage to the eyes, including blindness, inhalation of hydrogen peroxide vapors can be severely irritating to the nose, throat, and lungs

20. Pre-cleaning At Point of Use
Scope immediately wiped down at point of use (in the procedure room) and channels flushed with enzymatic, detergent.
For other instruments, follow manufacturer IFU.

21. Transport
Scope is safely transported to the cleaning area/decontamination room in a leak-proof, puncture-resistant container/device labeled as biohazardous which is based on evidence-based guidelines, manufacturer instructions for use

22. Decontamination Area
Scope is leak tested; if fails, finish processing, remove from service, and send for repair
All accessories are removed for cleaning or discarded if disposable – following manufacturer’s instructions for use
Scope and accessories immersed in measured enzymatic detergent

23. Decontamination Area
Cleaning solution is changed after each scope is cleaned, based on manufacturer instructions for use
All channels and accessories thoroughly brushed with manufacturer recommended brushes

24. Manual Clean
High Level Disinfectant (HLD) solution and concentration monitored and documented and dated as per manufacturer instructions for use
If test strip fails while checking HLD minimum effective concentration, discard & replace HLD; if problem with test strips, use different bottle – always check expiration dates

25. Manual Clean
Test strips should be dated upon opening with the discard date as per manufacturer instructions for use, and quality control conducted per label instructions
High-level disinfectant used is FDA-approved; used per label directions (contact time) all items completely submerged
Temperature of the HLD meets HLD label instructions

26. Manual Clean Soak time meets manufacturer’s label instructions
Scopes rinsed 3 times with sterile water or water as per manufacturer’s instructions for use; flushed with alcohol and compressed air after high-level disinfection

27. Storage
Scopes thoroughly dried before storage – there should be no water-staining at the base of the storage cabinet which may reflect an inadequate drying process
Scopes vertically hung in a manner that prevents contamination; scope attachments are dried and stored as per manufacturer instructions for use and evidence-based guidelines
Scopes reprocessed per evidence-based guidelines, manufacturer, and organizational policy

28. High-level Disinfection (HLD) – Using an Automated Endoscope Reprocessor (AER)
Point of use precleaning and transport to decontamination are the same as for manual cleaning

29. Decontamination With AER
Leak test if AER doesn’t do this
If fails, finish processing, remove from service, send for repair
Manual cleaning, brushing is performed

30. Decontamination With AER
HLD solution concentration is checked and documented; changed if test strip fails
Test strips dated with discard date as per manufacturer instructions for use and quality control per label
Scope connection instructions posted near the AER; proper connectors used

31. Decontamination With AER
Cycle run, meets HLD contact time and temperature
AER set for triple rinse in accordance with manufacturer’s IFU

32. Drying and Storage
On completion of cycle, if AER doesn’t include a drying process, flush channels with alcohol and compressed air
Scopes vertically hung in a manner that prevents contamination; scope attachments are dried and stored separately

33. Storage
On visual inspection, do these areas look clean, free of debris, and dry?
Is there a regular cleaning schedule of cabinets?
Is cabinet surface intact and cleanable?
Is equipment stored not touching the base of the cabinet?
Are scopes stored according to manufacturer instructions for use?

34. Clean/Dirty That Is The Question
Must be able to clearly differentiate clean from dirty

35. Space and Equipment Is there sufficient work space?
Is there an appropriate hand-washing or alcohol- based hand rub station?
Is there an appropriate eyewash station?
Are cleaning supplies, storage areas, and other critical items clearly labeled?

36. Ventilation
Is there negative air pressure in the decontamination room to surrounding areas?
Are air exchange rates and filtration efficiencies appropriate (per your facility manager)?
Is exhaust vented directly outside?

37. Environmental Controls
Temperature
AAMI: 18°C to 24°C [65°F to 75°F]
Humidity
AAMI: 30% to 60%
Airflow
© Sylvia Garcia-Houchins
Physical factors such as temperature, humidity, air exchanges, ventilation exhaust, adequate space and equipment can also affect the disinfection and sterilization process. Physical properties of CSP and decentralized reprocessing areas should meet local building code requirements as well as specific requirements established by the manufacturer’s of equipment and supplies used in these locations. In the absence of local guidance the following physical areas are recommended.
© Sylvia Garcia-Houchins
© Sylvia Garcia-Houchins

38. Workflow
Are staff stopped before entering the area and asked to put on PPE?
Does work flow from soiled areas to clean?
Does the route from the processor to the storage cabinet avoid crossing through the soiled processing area?

39. Separation of Clean and Dirty

40. In Decontamination Setting
Personal Protective Equipment (PPE) is worn and includes:
Hair covering/cap
Face mask/shield
Fluid resistant gown
Gloves used should be durable to prevent tearing and leaking of chemicals and/or contaminated fluids when the user’s hands are under water
Note a distinct flow and separation of dirty and clean processes that minimizes the risk of cross- contamination

41. Decontamination Cleaning Process Demonstrate Labeling of sinks
Standard work with low/no variation
Job aids
Manufacturer’s instructions (temp, measurements)
Training & Competency

42. Questions to Ask
Is there an inventory list of all scopes maintained in the department?
Do staff know how frequently these are maintained and how that maintenance occurs?
When staff members are questioned, can they show where manufacturer instructions and evidence-based practices and guidelines are located?
Do all staff have competencies on file? Who signed them off as competent?

43. Common Findings With HLD
Not pre-cleaning at point-of-use
Reusing single use brushes
Reusable brushes to clean endoscopes not being cleaned or disinfected between each use or at the end of the day per evidence-based guidelines or manufacturers’ instructions for use
Use of a low-level disinfectant wipe instead of a high-level disinfectant to reprocess equipment between patient use

44. Common Findings With HLD
Lack of quality monitoring, documentation, (temperature, time, minimal effective concentration of high-level disinfectant) per manufacturers’ instructions for use or evidence-based guidelines

45. Clarifying Standard Requirements: High Level Disinfection

46. Endoscope Sheaths, AAMI ST91
Endoscope sheaths are available for use with specified endoscopes.
The instructions for endoscope processing for some of these devices recommend alternative processing instructions to conventional liquid chemical sterilization/high-level disinfection when the sheath remains intact after endoscope use.

47. Endoscope Sheaths, AAMI ST91
For these endoscopes and sheaths, the manufacturer's written IFU should be followed.
If the processing instructions from the endoscope manufacturer and the endoscope sheath manufacturer appear to differ or to conflict, personnel should contact each manufacturer to request additional information and make their own decision based on all available information

48. Documentation and Record Keeping, AAMI ST91
Assigned lot number, including chemical sterilizer, AER, or soaking container identification and cycle number
Specific contents of the lot or load, including quantity, processing area, and a description of the items
Patient’s name and unique patient identifier
Procedure, physician, and, if applicable, serial number or other identification of the item

49. Documentation and Record Keeping, AAMI ST91
Exposure time and temperature, if not provided on the physical monitors
Date and time of cycle
HLD type and concentration; pH test results if required by facility policy or manufacturer's written IFU
Name or initials of the operator

50. Documentation and Record Keeping, AAMI ST91
Results of MRC or MEC solution monitoring strip, if applicable;
Results of the quality control of test strips, if applicable

51. Education and Competencies
Upon hire
Recommend at least annually
Whenever new item or equipment
borrowed
leased
purchased
Whenever new policies and procedures are implemented

52. Education and Competencies
Determine frequency of competency and training based on staff turnover, purchasing new equipment or products, or a breach in the process has been identified
Random observations
Who signs off on competencies?
Who signed them off?

53. Education Principles of cleaning, disinfection and sterilization
Inspection, preparation, and packaging of instruments
Worker safety and use of personal protective equipment (PPE)
Manufacturer’s instructions for use
Quality control of processes
Endoscope model specific cleaning and disinfection, if applicable

54. Questions or comments?
Thank you!