Some Americans think of federal agencies as giant bureaucracies that no one would miss if they went away. While they all serve important purposes, there’s no question that there’s always room for improvement. Like any other organization, they can become too large and unwieldy, fail to keep up with important advances and become beholden to special interests.
A study published in the journal Health Affairs discusses some problems with the recall process for medical devices that are the responsibility of the Food and Drug Administration (FDA) under the oversight of the Government Accountability Office (GAO). Millions of Americans rely on all kinds of medical devices – from pacemakers to ventilators to artificial hips and more. Defects in them can be fatal.
That’s why it’s especially concerning that the study concluded, “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.” They pointed to an increase Class I recalls. These recalls are reserved for cases where “there is a reasonable probability of a “serious adverse health consequences or death.”
Recommendations from doctors for improving the system
That often means that serious defects aren’t being caught before the product goes on the market. So how can the system be improved? Doctors’ recommendations included the following:
- The GAO should give the FDA greater ability to “identify safety concerns before device authorization.”
- There should be better collaboration on recalls between the FDA and medical device manufacturers
- The FDA should not hesitate to use its “existing enforcement authorities.”
They also stressed that “political pressure on the agency” needs to be minimized. Certainly, a recall of a medical device that costs thousands of dollars can mean a serious financial loss for the manufacturer. That can bring a lot of pressure to bear by lobbyists and lawmakers who rely on their support.
It shouldn’t have to take costly lawsuits by victims of defective devices to incentivize them to ensure the safety of their products. There’s no doubt, however, that they dread the financial and reputational damage they can do. If you or a loved one has been harmed or worse by a defective medical device – or any product – it’s important to get legal guidance to protect your right to fair compensation.