Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Ms. Erin Coke Date/Time 2002-09-05 16:16:30
Organization Ashland Community Hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments We do not reprocess open but unused products due to your SUD information. It was our understanding that the SUD guidelines included reprocessing open- but unused items, since resterilization may change the performance of an SUD. Please let me know if open-but unused items fall into a separate category not included in your SUD guideline. Thank-you, Erin Coke




EC -3