Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -17

Accepted - Volume 1

Comment Record
Commentor Mrs. marcia mcnicol Date/Time 2002-09-16 11:28:33
Organization NMT Group
Category Company

Comments for FDA General
1. General Comments A)There are companies who produce and supply safety devices to aid in the reduction of accidental needlestick injuries in commercial quantities. As a safety device manufacturer we would support a ban on products which could be replaced by truely safe alternatives. The only effective way to protect the healthcare worker and any downstream worker is to eliminate non safety sharps, this appears to be slowed by existing supply agreements with companies to supply traditional products into the healthcare field. B) The development of a performance standard would aid in the manufacture and control of safety devices, currently the FDA 1995 guidance on the 510k submission for medical devices with sharps injury prevention features can be used to establish direction however is not perscriptive in its content. C)Labeling on conventional syringes to warn against using for standard blood draws may help to draw some attention to the risk associated, however focussing on risk mangement and risk assessments for tasks would provide better awareness of the issues.

EC -17