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
Purpose:
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.
Definition:
Reprocessing refers to the steps performed to prepare used medical equipment/devices for reuse.
Responsibility:
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.
| ITEM | YES | NO | PARTIAL | COMMENTS |
|---|---|---|---|---|
| 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) | ||||
| Cleaning | ||||
| 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 | ||||
| Sterilization | ||||
| 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 | ||||
| Education | ||||
Manager and staff are educated on how to reprocess instruments when:
|
||||
| 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:
Date:
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