Do FDA Regulations on Medical Devices Protect Patients?

This morning, Alliance for Justice was present for the House Committee on Energy and Commerce Subcommittee on Health hearing entitled, "Medical Devices: Are Current Regulations Doing Enough for Patients?" The hearing examined the Food and Drug Administration's (FDA) regulation of medical devices, and analyzed whether additional regulatory steps are necessary to ensure the safety, effectiveness and quality control of medical devices such as X-rays, pacemakers, and heart valves.

Congressman Braley (D-IA) noted that the topic before the Subcommittee was critical and urgent because the “safety of American patients is a matter of utmost importance.” He noted that ensuring patient safety through judicial accountability was essential, and urged Congress to move swiftly to pass the Medical Device Safety Act of 2009 (HR 1346). The Medical Device Safety Act legislation is required because FDA approval of medical devices is an insufficient mechanism to protect patients. Rather, we need the complimentary systems of competent FDA regulation combined with the oversight of state courts in order to save American lives.

Opening the testimony before the Subcommittee, Dr. Marcia Crosse, Director of Healthcare for the Government Accountability Office (GAO), testified that the GAO has identified a number of concerns within the FDA. Dr. Crosse noted that Americans depend on the FDA to regulate the safety of their medical devices, but that the FDA is falling short of meeting this challenge. As a result, the GAO considers FDA oversight of medical products a “high risk area.” Currently, two-thirds of all medical devices have no pre-market FDA review (these include products like bandages). However, there exists a higher-risk one-third of medical devices that require greater oversight to ensure consumer safety, but the FDA is limited in its review of these devices because of time and budget constraints. For example, the FDA cannot inspect domestic factories that manufacture medical devices on schedule, and is even further behind with inspections of foreign factories.

The importance of having competent, comprehensive, and timely FDA review of devices was emphasized by Dr. William H. Maisel, a cardiologist with Beth Israel Hospital, who noted that the FDA currently regulates over 100,000 medical devices produced by more than 15,000 companies. As a result of problems with the review process, the system leaves unanswered questions when devices are approved, which results in patients being exposed to harm. He told the story of one of his patients, a World War II veteran, who suffered cardiac arrest in front of his wife when he fractured his Medtronic Sprint Fidelis defibrillator lead simply by pulling his shirt over his head to get ready for bed. The Sprint Fidelis lead design was approved by the FDA even though Medtronic failed to submit any clinical performance data. To compound the problem, the FDA did not require any additional review of the product after the design was approved and released onto the open market. As a result, thousands of Americans have been shocked or killed by this faulty lead.

Watch a webcast of the entire hearing.

Sign AFJ’s petition urging Congress to pass the Medical Device Safety Act of 2009.