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Why Americans can’t always trust the medical device recall system

When it comes to the recall of unsafe products, you would think that government regulators would be more stringent about getting defective or dangerous medical devices off the market than just about any other type of item. A recent article published in the Health Affairs journal indicates that this is not always the case.

The doctor/authors of the piece, who studied the medical device recall process used by the Food and Drug Administration (FDA) and overseen by the Government Accountability Office (GAO), concluded that “The current system for tracking medical device safety and conducting medical device recalls is failing to meet the needs of public health amidst increasing consequential recall frequency and severity.”

According to the doctors, who made recommendations to both the GAO and FDA for ways to improve their oversight of medical devices, these failures have increased the number of adverse event reports and the number of Class I recalls. Class I indicates the greatest level of urgency for recalling a device. Specially, it’s used when “there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”

What can be done to improve the system?

The doctors’ key recommendations for the GAO include the following:

  • Give the FDA greater ability to “identify safety concerns before device authorization.”
  • Work on better collaboration between the FDA and medical device manufacturers in recalling potentially dangerous products.
  • Help the FDA better use its “existing enforcement authorities,” including minimizing “political pressure on the agency.”

Certainly, it’s distressing to think that politicians (perhaps pressured themselves by lobbyists for the medical device industry or executives for large corporations) and others could successfully keep the FDA from getting a dangerous product off the shelves and out of unknowing doctors’ and patients’ hands.

While everyone wants to be able to trust their doctors, it’s always a good idea to do some research on a medical device before you use it and certainly before it’s placed in your body. With that said, if you or a loved one has already suffered harm or worse as a result of a defective device, it’s important to have experienced legal guidance to seek justice and compensation.


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