Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -1

Accepted - Volume 1

Comment Record
Commentor Ms. A Herrnstein Date/Time 2002-09-05 09:32:51
Organization Carolinas Healthcare System
Category Company

Comments for FDA General
Questions
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 staff that hospitals do not in order to complete validation of sterilization. We believe the FDA must create guidelines to specify contamination of a single-use medical device. Devices could be open not used, but be exposed to blood or airbourne pathogens; such as TB. Those exposures would require cleaning in addition to sterilization. Otherwise, an open not used device is exposed, not soiled, 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 to follow.




EC -1