Retraitement des dispositifs médicaux du Canada

This Standard is intended to form the basis of a medical device reprocessing department (MDRD) quality management system (QMS) within a health care setting for the purpose of providing safe, reliable reprocessing of reusable medical devices.

It defines essential elements for

1. quality management, including

   1. policies and procedures;

   2. < >

      roles and responsibilities;

   3. management review;

   4. personnel qualifications and training; and

   5. adverse event management (e.g., recalls);

2.  

3. occupational health and safety;

4. evaluation and purchase of reprocessing equipment and reusable medical devices;

5. infection prevention and control;

6. work areas and equipment;

7. environmental conditions;

8. utilities (e.g., power supply, water, and steam quality);

9. the safe handling, transportation, and biological decontamination of contaminated reusable medical device;

10. using steam and chemical methods to sterilize medical devices in health care settings;

11. the evaluation, selection, inspection, and proper use of preformed sterile barrier systems, sterile barrier systems, and packaging systems;

12. the storage, handling, transportation, and distribution of single use and reusable medical devices in facilities where open-inventory (split-case) storage and handling services are provided;

13. the selection and use of gowns and drapes in health care settings and laundry services; and

14. the maintenance, laundering, and preparation of reusable gowns, drapes, and wrappers in health care settings and laundry services.