| Comment Record|
Ms. Melanie Miller ||
2002-09-12 18:45:23 |
Cedars-Sinai Health System |
Health Professional |
| Comments for FDA General |
1. General Comments
Currently, we do not reprocess single use medical devices that are opened. Therefore, currently we do not have a policy regarding this practice.
We are considering the merits of reprocessing for single medical devices that are opened, but, unused through a third party reprocessor.
Ensuring that the product has not been contaminated will be an important consideration. The reprocessor must provide collection containers that guarantee product integrity in transit. Additionally, the hospital must provide the opened, but,unused medical device to the reprocessor ensuring compliance with the key elements below:
the inner package is clean
the medical device has not come in contact with blood or body fluids
the inner package is dry and intact
The types of medical devices under consideration:
Arthroscopic blades and wands