Docket Management
Docket: 00D-0053 - Determining Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices
Comment Number: EC -20

Accepted - Volume 5

Comment Record
Commentor Miss Sandra J. Pfaff, BSN, RN Date/Time 2002-10-08 08:31:23
Organization Alice Hyde Medical Center
Category Individual

Comments for FDA General
1. General Comments There is no reason to deny healthcare facilities the option to re-sterilize opened-but-unused, single-use medical devices PROVIDED (1) the manufacturer provides written information on how the device was originally sterilized, (2) the manufacturer provides written information on how to re-sterilize the item, (3) the manufacturer provides written guidance on how many times the device can be re-sterilized, and (4) the healthcare facility has the appropriate technology to re-sterilize the item per the manufacturer's instructions. As an Infection Prevention and Control professional and one who has taught sterilization nationally and in developing countries, I am aware of the cost benefit of re-sterilizing unused devices. However, I am also aware that not all healthcare facilites have the equipment or know-how for this process. I am concerned that manufacturers will withhold re-sterilization information from healthcare facilities in order to boost sales of their products, rather than collaborating with healthcare in reducing healthcare costs. Thank you for the opportunity to comment on this issue.

EC -20