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High Risk Devices Approved With Limited Safety Data

Mario Rosales1 year ago

Data suggests that the problem has been that the U.S. Food and Drug Administration (FDA),the primary agency that approves medical devices for consumer use, has been approving certain high risk devices with only one or two studies backing their safety for patients.

Many other countries including the U.K and Canada have similar policies, but they have much better capacity to follow devices once they are in practice.

About Medical Device Approval  

According to Reuters, the U.S relies on the FDA to determined the safety of medical devices and protect patients and consumers from potentially dangerous devices.

However, a recent analysis shows the FDA approves certain high risk medical devices that are backed by few studies. Further, medical suppliers are unable to track these devices once they are in practice.

Many countries such as Canada use an electronic health records (EHR) system to monitor devices in use and record when there are problems. The U.S unfortunately does not have such as elaborate system in place and this can be a cause for worry.  

The FDA currently relies on only one study for each device in order to approve its use. 

What Are Considered “High Risk” Devices?

All of the following information was provided by Reuters News Agency:

  • “High risk” devices are tools that hospitals use that sustain human life or can at times pose a potential risk to it.
  • Of the 28 such devices granted initial marketing approval by FDA during the study period, 15 were new stents for the heart or elsewhere in the body. Ten were later recalled from the market.
  • Five devices had no post market studies, and 13 others had three or fewer post market studies. Half of the studies did not compare the new device to an existing one.


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