Nov 26, 2018

Exporting dangerous medical devices

More than a dozen medical devices registered with the FDA for export to other countries — but not for use in the U.S. — have been identified as having "troubled track records" in an investigation by NBC News.

Between the lines: This raises questions about whether it is America's job to evaluate whether a medical device is safe for use in another country. But it also shows what can happen if health care companies are left alone to decide between consumer safety and profit.

Details:

  • These devices include heart valves that caused severe infections, shoulder implants that needed to be removed and stents that could cut into arteries that they were supposed to save.
  • There are about 4,600 devices registered with the FDA as "export-only," and American companies made more than $41 billion last year on exporting medical devices.
  • Some of the companies that make the devices identified by NBC failed to report serious adverse events.

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