Investigative reports on medical devices prods FDA to overhaul approval process

By PharmaCompass

2018-11-29

Impressions: 127 Article

After their exposé on how deeply offshoring is embedded in the global financial system, the International Consortium of Investigative Journalists (ICIJ) published a scathing investigation into medical device failures across the world and how the US Food Drug Administration's accelerated review process may have missed problems and put consumers at risk.

An investigation carried out by 58 media organizations has revealed instances where patients were given implants that are unsafe. Medical devices range from implanted contraceptives to hip replacements to pacemakers in the heart.

A BBC report quoted the Royal College of Surgeons and said urgent and drastic changes to the rules around medical devices, such as pacemakers, are needed to protect patients. They found implants, which had failed in trials, being put into patients.

Similarly, an Associated Press article said medical device companies and doctors tout spinal-cord stimulators to treat patients suffering from a wide range of pain disorders. But an investigation found the devices rank third in injury reports to the US Food and Drug Administration (FDA) over the last 10 years. Over 80,000 incidents have been flagged since 2008.

Following these investigations, this week the FDA said it plans to overhaul more than 40-year-old process for approving medical devices that some say puts consumers at risk. The agency plans to overhaul the 510(k) clearance process for medical devices. FDA Commissioner Scott Gottlieb said the agency wants to push the medical device market toward new technology.

Since 1976, manufacturers have been able to pursue an expedited approval process, known as 510(k). By modernizing the 510(k) approval process, the FDA wants companies to base new products on devices that are no older than 10 years.

Last year, the FDA cleared 3,173 devices through the 510(K) system. Nearly 20 percent of products cleared through the 510(k) pathway were based on a predicate device that's more than 10 years old.

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“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”

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