Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -9

Accepted - Volume 5

Comment Record
Commentor Ms. Celeste Erickson Date/Time 2002-09-10 20:42:38
Organization Group Health Cooperative of Puget Sound
Category Health Professional

Comments for FDA General
1. General Comments 1. Yes, our hospitals have a written policy that includes re-sterilization of SUD's that are opened but unused. 2. Our policy requires we have sterilization instructions from the manufacturer before we consider resterilization of an opened-but-unused item. And just as sterile shelf-life is determined by environment and events, we consider whether to resterilize by examining the item for any visual evidence of contamination and evaluating how the item and its original package were handled after opening. For example, what were the risks of contamination before being brought to CSR?... did it sit for a considerable time, open and unprotected, was it handled by multiple and/or contaminated hands, did it travel with the rest of the unused instruments to Decontam... or was it left in an inner protective package, handed to trained staff in the clean core and brought immediately to clean assembly? Actually, requests to resterilize are infrequent because our policy has, for many years, had strict criteria for both reuse and resterilization of open-unused. Sometimes we are contacted in advance, and we have the opportunity to assist in a plan to reduce waste for the procedure. Also, department labor/packaging/sterilization costs are not insignificant, so items costing under $10 are usually not considered.

EC -9