Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -2

Accepted - Volume 1

Comment Record
Commentor Ms. Anna Herrnstein Date/Time 2002-09-05 10:06:17
Organization Carolinas Healthcare System
Category Health Professional

Comments for FDA General
1. General Comments It is the opinion of the OR Reprocessing Committee at Carolinas Healthcare System that Reprocessing Open, but not used is beneficial to hospitals. Third-party reprocessors have the available staff and expertise to complete the validation of sterilization. We believe the FDA should create guidelines to clarify contamination of a single-use medical device. Devices could be open not used, but be exposed to blood or airbourne pathogens. Those exposures would require cleaning in addition to sterilization. Otherwise an open not used devices is not soiled but exposed to that patient in the OR. In both cases, functionality testing may not have to be a requirement of the reprocessing cycle. Overall, reprocessing of open, but not used single-use devices is beneficial to hospitals with the assistance of established guidelines for those hospitals and third party reprocessors to follow.

EC -2