scope:

This Standard specifies the requirements and practices necessary for the effective and safe reprocessing, storage, handling and transportation of reusable medical devices (RMDs) in human health care.

The application of the principles of this Standard recognizes and acknowledges that there are similarities and differences between different types of HSOs (e.g. hospitals, and dental general and podiatry practices).

The similarities are the common need for quality systems, staff training, and compliance with reprocessing procedures. The major difference relates to the unique physical and organizational conditions in different types of HSO (e.g. reprocessing equipment and ability to physically segregate the reprocessing environment).

The principles of this Standard are also applicable to processing of single use medical devices supplied to HSOs by the manufacturer in a non-sterile state and which require sterilization in accordance with the medical device manufacturer's processing instructions prior to use.

This Standard is applicable wherever RMDs are reprocessed in HSOs, including the reprocessing of RMDs used in post-mortem examinations.

Infection prevention and control practices preclude the interchange of RMDs between postmortem examinations and live patient health care. Infection prevention and control practices also preclude the interchange of RMDs between veterinary and human health care, including RMDs used in preclinical training on animal tissue.

The principles of this Standard may be applicable to the reprocessing of RMDs in veterinary practice.