Appendix E: Infection Prevention and Control Guideline for Flexible Gastrointestinal Endoscopy and Flexible Bronchoscopy – Sample audit checklist for reprocessing of medical equipment/devices

APPENDIX E – Sample Audit Checklist for Reprocessing of Medical Equipment/Devices

NOTE: This checklist was adapted from Sunnybrook Health Sciences Centre

All medical equipment/devices used in healthcare settings in Ontario are to be reprocessed in accordance with both the Ministry of Health and Long-Term Care "Best Practices for Cleaning, Disinfection and Sterilization", Public Health Agency of Canada infection prevention and control guidelines and current CSA standards.

Reprocessing refers to the steps performed to prepare used medical equipment/devices for reuse.

Each Physician Program Head and/or department manager is responsible to verify that all medical equipment/devices reprocessed in the area for which he/she is responsible is being reprocessed according to the Ministry of Health and Long-Term Care Best Practices for Cleaning, Disinfection and Sterilization in All Health Care Settings.

Checklist:  Department/Area to be Audited
Reprocessing occurs in the area (if no – sign off checklist is complete)        
Single-use medical equipment/devices are not reprocessed.        
Personal protective equipment is worn when cleaning reprocessing (eye protection, mask, gown and gloves)        
Equipment/devices are cleaned using an enzymatic cleaner prior to reprocessing        
Is cleaning done in a separate area from where the instrument will be used i.e., designated dirty area)        
High Level Disinfection
Equipment/devices are subjected to high-level disinfection according to manufacturer's instructions, using an approved, high-level disinfectant (do not keep high-level disinfectant for more than 2 weeks even if test strip is still okay)        
High-level disinfectant concentration is checked daily        
Quality Control on test strips is carried out as per company guideline        
Test strip bottle is dated when opened        
Test strips are not used past the manufacturer's expiry date        
Log is kept of results of high-level disinfectant quality control        
Log is kept of instruments that receive high-level disinfection        
Log is kept of dates when high-level disinfectant is changed        
Two staff sign off that the correct solution was used when high-level disinfectant is changed        
Automated reprocessor has preventive maintenance program        
Log is kept of all preventive maintenance        
Log is kept of all maintenance associated with reprocessor        
Using checklist for reprocessing of endoscopes        
Equipment/devices are sterilized by an approved sterilization process        
Bowie Dick – done daily – high vacuum sterilizer        
Sterilizer physical parameters are reviewed after each run        
Log is kept of physical parameters        
Sterilizers monitored with biologic monitor daily (each type of cycle, i.e., flash, long loads)        
Log is kept of biologic monitors        
Sterilizer has a preventive maintenance program        
Log is kept of preventative maintenance        
If biologic monitor is positive, loads are recalled and the positive test is investigated        
Log is kept of all maintenance associated with a positive biologic monitor        
Indicator tape is used on outside each wrapped package        
Multi-parameter indicator used on inside each wrapped package containing 2 or more instruments        
Log is kept of each loan and items in load        
If flash sterilization is used, a log is kept of flash sterilizer use        
Flash sterilized equipment/devices are noted in the patient's chart along with reason        
All logs are to be retained according to facility policy        
All reprocessed equipment/devices are stored in a manner to keep them clean and dry        
Chemical indicators are checked before equipment/devices are used        
Is there a process in place that clearly identifies a non-reprocessed instrument from one that has been reprocessed to prevent use on a patient        
Purchasing and Reprocessing Instructions        
Manager/purchaser is aware of purchasing policy for all medical equipment/devices requiring reprocessing        
There are explicit written reprocessing instructions from the manufacturer on each equipment/device to be reprocessed        
Policy & procedure for reprocessing are written. These are compatible with current published reprocessing standards and guidelines        
Manager and staff are educated on how to reprocess instruments when:
  • First employed
  • Minimum of annually
  • Any authorized change in process
  • When new equipment is purchased – reprocessor
  • When new equipment is purchased – medical equipment/devices requiring reprocessing
Managers and staff have completed a recognized certification course in reprocessing or there is a plan to obtain this qualification with 5 years        
There is an audit and follow-up process in place for ongoing evaluation of reprocessing.  Appropriate people and Infection Prevention & Control are notified when follow-up is required        
Compliance with the Occupational Health and Safety Act R.S.O. 1990, c.O.1 and associated Regulations including the Health Care and Residential Facilities – O.Reg. 67/93 Amended to O.Reg. 631/05        

Checklist Auditor: 

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