Thursday, September 29, 2011

Study of Medical Device Recalls by FDA Over Last Four Years

Full report is from here:

Excerpts from the article:
The information that is publicly available on the FDA website was used to determine the number of devices which had been recalled over the period from January 2008 to June 2011. The information was then analyzed on how often the FDA issued high-risk recalls of medical devices.

The second highest category comprises of recalls due to malfunctioning of device which showed 35 device recalls, that is, 29% of the total recalls.
Given the ubiquity and variety of medical devices in modern healthcare, it is inevitable that a proportion will fail to perform as expected, or even cause harm. What seems unacceptable is increasing number of medical device recalls and a system of regulatory approval for devices that lacks even a basic level of transparency for independent evaluation.
  1. So what do you think is the acceptable proportion of medical devices that fail to perform, or cause harm?
  2. What do you think of the authors claim that the regulatory approval for devices lack the basic level of transparency for independent evaluation?

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