Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -7

Accepted - Volume 5

Comment Record
Commentor Mrs. Kris Sabo Date/Time 2002-09-09 15:35:39
Organization HEALTHSOUTH
Category Health Professional

Comments for FDA General
Questions
1. General Comments Items that are opened and unused/not contaminated can be appropriately decontaminated/sterilized and should be used at another time. It is not cost effective to discard these unused items. Documentation of sterile processing should be the same for these products as it is for surgical instrumentation.




EC -7