Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -17

Accepted - Volume 5

Comment Record
Commentor Mrs. Brenda Majors Date/Time 2002-09-26 16:12:10
Organization HCA Healthcare/West Florida Hospital
Category Health Professional

Comments for FDA General
Questions
1. General Comments We process open-unused (and some used) products from the OR and CSR areas at our hospital. We have a policy and procedure to help control the items choosen for reprocessing. The decision to reprocess is made once it is determined that the item is acceptable by the reprocessing company and it is financially reasonable. Our choices are also governed by the reprocessing company's policy and procedure. There are restrictions that we have to adhere to, ie. no latex products, no suture, no drapes/gowns, etc. The reprocessing company has a list of items that have been approved by the FDA standards and unless the product is on the list we don't send it. We have a designated area for collection of opened, unused items if we don't know that they are acceptable for reprocessing. Each time our rep comes he reviews the items in question and notifies us of the items we can send for reprocessing. If we have any qualms or questions about a product we will not submit it for reprocessing until it has been researched by contacting other hospitals or working with the reprocessing company until our concerns are answered. If any product is opened onto a contaminated area or handled by a staff member with contaminated gloves it is considered contaminated and put into the collection container for used items. Saw blades, drill bits, etc. that are used in surgery are sent to our sterile processing area to be rinsed along with our regular instruments and then put into a collection container. All items are collected and sealed for transfer to the reprocessing plant by our rep. Contaminated items are not handled by any of our hospital staff once it is put into the collection container. Since this is a new idea we don't have a wide spectrum of items we send off for reprocessing. Our main open-unused items are tourniquets, saw blades, drill bits, burrs, staplers, clip appliers, trocars and arthroscopy blades.




EC -17