Insufficient Approval Process May Lead to Defective Medical Devices

Medical devices, designed to alleviate pain and improve health, are implanted into hundreds of thousands of patients each year. But are they safe?

Consumer Reports recently conducted an investigation into the approval process for medical devices by the U.S. Food and Drug Administration. The investigation included a review of the FDA’s medical research, and interviews with doctors and patients.

Concerns with Medical Devices

On its website, Consumer Reports outlined several concerns it has over the medical device approval process following its investigation:

  • Too often, medical devices aren’t tested before they are used in patients
  • There’s not a formal manner in which problems with medical devices are communicated to patients, researchers and physicians
  • Without changes in the current approval process, patients have little opportunity to protect themselves

Consumer Reports is not alone in its concern over defective medical devices. In 2011, the Institute of Medicine, an independent, nonprofit organization, raised its own issues over the approval process for medical devices. Congress passed the Food, Drug and Cosmetic Act in 1976. That law included a fast-track approval process for medical devices, known as the Pre-market Notification, or 501(k). The purpose of the law is to cut the red tape and speed up the time for low-risk medical devices to get to market. But since its passage, many high-risk devices – heart valves and hip implants, for example – have been inappropriately and dangerously approved under 501(k), according to the Institute of Medicine.

Consumer Reports and the Institute of Medicine have focused on the need to stop defective medical devices reaching the market. But inevitably some will, no matter what changes are made to the approval process.

Victims of defective medical devices and their families may pursue wrongful death lawsuits and product liability lawsuits against the manufacturer of the devices, just as they can with any defective consumer product, to obtain fair and just compensation for the losses.