On April 14-16, 2014, I attended the Association for the Advancement of Medical Instrumentation (AAMI) semi-annual Sterilization Standards Meeting. These Association meetings, and the standards discussed during them, have a major impact on medical device manufacturers, testing facilities, HCF managers, and the FDA.
Processing of reusable medical devices is an extremely hot topic with manufacturers and regulators. Many working groups, standards, and technical informational reports are currently being written and revised by the AAMI and ISO committees. We are very involved in all of the meetings and document updates.
Highlights from the meetings include:
- AAMI TIR34 – Water for the Reprocessing of Medical Devices – This document will be submitted for final 30-day review this summer. The categories of water have changed, so medical device manufacturers may want to use these categories in their IFUs as this is the quality of water that the healthcare facilities will use for their reprocessing.
- AAMI TIR55 – Human Factors for Device Reprocessing – This document is going to ballot for the first time. It is a great document designed for medical device manufacturers to provide guidance from a human-factors perspective.
- AAMI TIR63 – Management of medical devices that are not owned by the healthcare facility where they are used – This document is now going to ballot after successfully responding to all of the comments provided for the last meeting. This document will help manage medical devices that move between healthcare facilities.