Docket Management
Docket: 01P-0120 - Medical Devices; Needle-Bearing Devices; Request for Comments and Information
Comment Number: EC -21

Accepted - Volume 1

Comment Record
Commentor Mr. Ron Thackery Date/Time 2002-09-18 15:38:32
Organization American Ambulance Association
Category Association

Comments for FDA General
Questions
1. General Comments September 18, 2002 Margaret M. Dotzel Associate Commissioner for Policy Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, Maryland 20850 RE: Safer Sharps [Docket No. 01P-0120] Dear Associate Commissioner Dotzel: The American Ambulance Association (AAA) greatly appreciates the opportunity to provide comments on additional actions the Food and Drug Administration (FDA) should take to protect healthcare workers from needlestick injuries from medical devices. While we commend the FDA for its current efforts to address the issue, we believe that the FDA can do even more to reduce the exposure of needlestick injuries to medics and other emergency service personnel. One problem that medics and safety professionals consistently encounter is the continued exposure to bloodborne pathogens with safer sharps. Manufacturers have increased efforts in the design and development of safer sharps that are intended to reduce the risk of exposure to healthcare professionals. However, many of these design features continue to require manual manipulation of the device to activate safety features. The process of manual manipulation continues to present healthcare workers with the potential for unnecessary exposure. Because these devices are promoted as safer sharps, health care providers are encouraged to purchase these items - when in fact they prove to be no safer than the traditional sharps they replace. In fact, the Occupational Safety and Health Administration (OSHA) will issue citations and penalties for health care providers that do not utilize safer sharps. Consequently, the AAA is pleased to have this opportunity to comment and would advise the FDA to implement processes that assure that end users of these engineered products will experience a reduced incidence of exposure. Manufacturers should be required to scientifically establish the reduced likelihood of exposure from the use of their newly engineered devices. If the FDA requires manufacturers to meet these stringent requirements, the potential for exposure to medics and other health care workers can be significantly reduced. If you have any questions pertaining to these comments or the exposure of needlestick injuries to medics, please do not hesitate to contact AAA Director of Government Affairs Tristan North. He can be reached at (703) 610-0216. Thank you for your time and consideration. Sincerely, Ronald W. Thackery




EC -21