Docket Management
Docket: 02N-0456 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -15

Accepted - Volume 1

Comment Record
Commentor Ms. Karen Hausteen Date/Time 2002-09-17 22:50:00
Organization operating room nurse
Category Health Professional

Comments for FDA General
1. General Comments I have worked in operating rooms for about 20 years. I feel that items that have been opened BUT not used, implanted, or contaminated in any way by blood or body fluids should be re-processed for use at a later time. There is a lot of waste with single use items - waste of materials to manufacture the item, and waste of space in trash sites. Reprocessing an item saves materials, time of manufacturing and money. Please approve this practice and set guidelines for reprocessing of these single use items. Thank you for your time. Karen Hausteen, RN, CNOR, RNFA

EC -15