FDA discusses medical device controversiesPosted on May 02, 2009
Attorney Ronald E. Johnson of Schachter & Hendy concentrates on legal issues regarding defective medical devices. A recent article in The New York Times said that the Food and Drug Administration held an internal meeting to discuss the many controversies about medical devices.
The meeting addressed complaints by scientists who sent letters to President Obama about what they claim are illegal actions by FDA agency officials and their concerns about patients being at risk by medical devices that were approved for sale despite concerns from scientific reviewers.
Congress has opened an investigation into the scientists' concerns. A report of the Government Accountability Office was critical of the medical device center. This week legislation was introduced to Congress asking the Institute of Medicine to investigate concerns about the device center.
Among the devices the dissidents say the agency has approved inappropriately are imaging equipment used to detect breast cancer and an orthopedic knee device. The agency has also allowed hospitals to wash and reuse surgical devices intended for just one use, they said.