Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -18

Accepted - Volume 1

Comment Record
Commentor Mr. Ron Bouchard Date/Time 2002-10-04 16:57:50
Organization University of Virginia Medical Center
Category Academic

Comments for FDA General
Questions
1. General Comments The following is the UVA Medical Center Response to the Food and Drug Administration request for comments on open, unused single-use medical devices. 1. Whether or not hospitals have a written policy or procedure for handling sterile, single-use devices that are opened but unused. Response: The University of Virginia Medical Center has a policy for handling sterile, single-use devices that are opened but unused. Single use devices eligible for reprocessing that have been opened but unused are reprocessed through FDA approved external third-party reprocessors. 2. How hospitals determine if the device is contaminated if opened and unused. Response: The Medical Center considers any and all opened and unused devices to be “contaminated” and therefore requires that all must go through the reprocessing set forth above. 3. What types of devices are resterilized because they are opened but unused. Response: All disposable medical devices labeled for single use by the original equipment manufacturer may be reused.




EC -18