Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -11

Accepted - Volume 1

Comment Record
Commentor Mrs. carla bolger Date/Time 2002-09-16 20:07:33
Organization dominican hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments hi. our hospital sends these items to a reprocessing company which supposedly warrants the items for safety as if they were new. as a long time operating room nurse, i have seen things reprocessed in the hospital as well as through outside vendors. in twenty some odd years of or nursing, i have often heard of the purported dangers of using resterilized disposables.but i have never experienced any items to fail, nor have i heard of any from my peers. i think that given the outrageous cost of surgical supplies, and the apparent safety of properly reprocessed single use items, it is prudent and reasonable to issue guidelines which acknowledge the realities of modern practice.also, it conserves resources and creates less waste.thank you, carla bolger




EC -11