Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -15

Accepted - Volume 1

Comment Record
Commentor Ms. Melanie Miller Date/Time 2002-09-12 18:45:23
Organization Cedars-Sinai Health System
Category Health Professional

Comments for FDA General
Questions
1. General Comments Reprocessing Response 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: Burrs Bits Blades Clip Appliers Suture Arthroscopic blades and wands




EC -15