This week, Consumers Union, the advocacy arm of Consumer Reports, urged Congress to strengthen the law governing approval of medical devices.

The responsibility and role of the Food and Drug Administration to oversee approval of medical devices, was discussed earlier this week at a hearing by the Senate Committee on Health, Education, Labor, and Pensions.

While Consumers Union wrote a letter calling on Congress to strengthen the federal regulation of medical devices, some Senate members asserted at the hearing that the medical device industry was too restricted by government oversight, and questioned the way in which devices are reviewed for approval.

In its letter, Consumers Union said that it wants to ensure all implantable and life-sustaining medical devices are subject to more rigorous review by the FDA, and to establish a better system for tracking devices after approval, so patients and doctors can be notified when safety problems arise.

Lisa McGiffert, manager of Consumers Union’s Safe Patient Project, said that patients are at risk when oversight of medical devices is weakened.

The current system has allowed FDA to fast track approval of more than 90 percent of new medical devices based on whether they are similar to other devices already on the market, and without clinical trials that show the devices are safe and effective. It’s time to strengthen the federal law on medical devices, not scale back oversight at the expense of patient safety.

For the specific improvements that Consumers Union called for in regard to pre-market device approval, post-market surveillance, and maintaining conflict of interest standards, you can read the full letter to Congress.

Consumers Union Urges Congress to Strengthen Medical Device Oversight [Consumers Union]
Full Committee Hearing - Medical Devices: Protecting Patients and Promoting Innovation [Senate.gov]