Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -16

Accepted - Volume 1

Comment Record
Commentor Mrs. Judy Nohr Date/Time 2002-09-18 17:54:54
Organization Community Hospital of Monterey Peninsula
Category Health Professional

Comments for FDA General
1. General Comments Surgery just instituted a policy and procedure for opened-but-unused, single-use medical devices. We use Alliance Medical Corporation who has assured the hospital that strict guidelines are followed, items must be over $10, and there is a list of specific items that can be re-processed. There is also a list of items that are not acceptable. The process involves cleaning, functional testing, packaging, and sterilization of a previously used device. Even though Alliance abides by the same standards as the original manufacturer and have specific requirements, I still am concerned about the integrity and safety for surgical patients. I am also concerned about the standard of care which is not the same for every patient as some patients will have the original item from the manufacturer and other patients will have a reprocessed item from a third party.

EC -16