Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -3

Accepted - Volume 1

Comment Record
Commentor Mrs. Anne Moser Date/Time 2002-06-25 16:11:51
Organization Southwest Regional Cancer Center
Category Health Professional

Comments for FDA General
1. General Comments I would like to suggest that the FDA better coordinate with OSHA in its efforts to approve blood collection devices that are allowed to be put on the market. Case in point: Our company recently purchased, and began utilizing, Becton Dickinson Pronto Quick Release Vacutainer needle/blood tube holders. We were told that this product was approved by the FDA. However, local and federal OSHA Compliance Assistant Specialists are telling us that this particular device is not permitted under the Bloodborne Pathogens Standard and should not have been approved for use.

EC -3