Docket Management
Docket: 01D-0514 - Medical Devices; Guidance on Labeling of Reprocessed Single Use Devices
Comment Number: EC -5

Accepted - Volume 1

Comment Record
Commentor Ms. Linnea O'Neill Date/Time 2002-02-22 14:35:09
Organization Metropolitan Chicago Healthcare Council
Category Association

Comments for FDA General
Questions
1. General Comments Dear Sirs & Madams: The Metropolitan Chicago Healthcare Council is a membership and service organization comprised of more than 100 hospitals and health care organizations working together to improve the quality of health care services in the metropolitan Chicago area. The Council’s Infection Control Subcommittee of the Committee on Clinical, Administrative, Professional & Emergency Services appreciates the opportunity to comment on the labeling of reprocessed single use devices. We recommend that the original equipment manufacturer’s name remain on the item. This is important for two reasons. First, physicians may prefer one device over another. Second, the hospital would want to know who the original equipment manufacturer was if there was a problem with the device. Thank you for the opportunity to provide comment. If you need clarification, please contact me at 312/906-6061 or via e-mail: loneill@mchc.com. Sincerely, Linnea O'Neill Assistant Director Clinical, Administrative, Professional and Emergency Services




EC -5