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Risk and Medtech
No medical intervention -- whether it involves a surgical procedure, a hospital stay, prescription pharmaceutical, medical device or OTC drug – will ever be entirely risk free. And despite the best efforts of industry and FDA, no amount of testing or review will be able to anticipate and prevent every adverse event or negative consequence. “That’s not the world we live in,” says Dr. Susan Alpert.
While not downplaying the fact that some patients have experienced severe negative impacts from some medical devices, Alpert maintains we have to have a realistic perspective about what is possible when it comes to addressing risks and to keep in mind the overall safety profile of the industry.
For example, some reactions associated with a medical device cannot be detected until extensive market experience is attained. This is especially true when the reaction impacts a small subset of a patient population. As Alpert puts it, “Sometimes it takes a lot of patients and a lot of time to see and understand certain risks with devices and to understand how to control them. It’s not a lack of concern for patients. It’s just the unknown.”
Policymakers and the public also must put any adverse events in context of “the volume of medical technologies that enter the U.S. market every year – more than 5,000 products. A very small number of those cause significant issues,” Alpert points out.
Tune in as Susan shares more about risk and medical technology in the video below. Learn more about Premarket Requirements.
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