Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -26

Accepted - Volume 1

Comment Record
Commentor Ms. Regina Piszcz Date/Time 2002-11-21 08:22:23
Organization Newport Hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments Single-use devices opened and unused are collected in clean containers and sent to a third-party reprocessing facility (Alliance Medical Corporation). These items are inspected, repackaged and resterilized. Any products containing a balloon or inflation apparatus are discarded as the integrity of these devices cannot be guaranteed. Any single use items below the dollar amount of $3.00 are also discarded and often times donated to third world countries.




EC -26