Personal Injury Law

FDA Meeting Held to Address Complaints About the Medical Device Approval Process

By Carrie Strasser

The New York Times reported last week that a rare internal meeting was held by the FDA on Wednesday to address the complaints surrounding the medical device approval process.

Dr. Donna-Bea Tillman, director of the agency's office of device evaluation, sent an e-mail message on April 10 announcing an 'all-hands meeting' to discuss the strategic direction of the device center. Such a broad-based meeting that includes all scientists within the device evaluation office has not been held for years, two agency officials said.

This meeting was spurred by letters to President Obama signed by nine scientists alleging that agency officials had acted improperly and put patients at risk by approving medical devices for use in spite of numerous objections from scientists reviewing the devices.

These letters have led to the opening of a Congressional investigation and a critical report of the device center released by the Government Accountability Office in January. Additionally, Congress is to propose legislation this week asking the Institute of Medicine to investigate the device division.

Specific devices that the scientists complained about were imaging equipment used to detect breast cancer and an orthopedic knee device. The scientists also charged that the agency has allowed hospitals to clean and reuse certain devices intended for only one use.

This meeting will hopefully be the first step toward greater concern for patient safety when it comes to medical devices. As of now, many patients harmed by certain medical devices have no recourse through the judicial system. However, if the approval process becomes more rigid, this could prevent avoidable injuries due to faulty medical devices. For more information on medical devices, click here.

Full post as published by Sacramento Personal Injury Lawyer on April 27, 2009 (boomark / email).