| 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.
|
|