How Safe Are Medical Devices: A Conversation with Diana Zuckerman (September 25th)
www.thehealthcarepolicypodcast.com
Medical devices, everything from tongue depressors to pace makers and defibrillators, are regulated by the FDA. How competently or effectively the FDA regulates these products has been questioned for several years in part due to the substantial increase in recent years in product recalls, for example the recall of certain hip implant devices. More specifically is the question whether the FDA's 510(k) process, that reviews or “clears for the market” medical devices, is adequate. An IOM study of the topic released in July 2011 reached the unanticipated and controversial conclusion that since, in part, 510(k) determines only “substantial equivalence” in clearing devices for the market, i.e., it does not evaluate device safety and effectiveness, the process should be scrapped and replaced. (Listeners will recall Dr. Zuckerman was interviewed last December about the excessive use of anti-pshychotics in nursing homes.)
How Safe Are Medical Devices: A Conversation with Diana Zuckerman (September 25th)
How Safe Are Medical Devices: A Conversation…
How Safe Are Medical Devices: A Conversation with Diana Zuckerman (September 25th)
Medical devices, everything from tongue depressors to pace makers and defibrillators, are regulated by the FDA. How competently or effectively the FDA regulates these products has been questioned for several years in part due to the substantial increase in recent years in product recalls, for example the recall of certain hip implant devices. More specifically is the question whether the FDA's 510(k) process, that reviews or “clears for the market” medical devices, is adequate. An IOM study of the topic released in July 2011 reached the unanticipated and controversial conclusion that since, in part, 510(k) determines only “substantial equivalence” in clearing devices for the market, i.e., it does not evaluate device safety and effectiveness, the process should be scrapped and replaced. (Listeners will recall Dr. Zuckerman was interviewed last December about the excessive use of anti-pshychotics in nursing homes.)