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Compliance In Focus
Posted by John Lehmann on Wed, Jun 6, 2012

Altering Medical Device Recalls

Medical Device RecallsIn the midst of all the legislation and money talk sweeping the medical device industry, another bill is being introduced to the mix. The bill, “Medical Device Patient Safety Act” has a few parts and provisions for consideration. A portion of the bill text outlines the goal to establish a program which would routinely and systematically assess device recall information; including:

  • Trends in the numbers and types of device recalls;
  • Types of devices in each device class that are most frequently recalled;
  • Causes of device recalls;
  • Length of time needed for a person subject to a device recall to complete the recall;
  • Length of time needed for the Secretary to terminate a device recall;
  • Whether the Secretary has performed a device recall audit check;
  • Which persons have been subject to the most device recalls;
  • Any other information as the Secretary determines appropriate.

Interestingly enough, the FDA just announced in the May 30, 2012 Enforcement Report its hopes to deliver a simpler, clearer report of device recalls to the public. According to an online article, the current  “Enforcement Report is organized by product type and by the severity of the recall, but it is difficult to find information in the report and does not contain any information to help consumers decipher the seriousness of each recall. The document is also prone to lags in information, as it can take time to classify a recall by order of its importance and risk to the public.”

It is vital that recall notifications reach the public in a fast and orderly fashion to protect patients’ health from defective, risky devices. It’s important to note that “a recall is either a correction or a removal depending on where the action takes place,” as stated on the FDA website. To elaborate;

  • Correction - Addresses a problem with a medical device in the place where it is used/sold
  • Removal - Addresses a problem with a medical device by removing it from where it is used/sold

The FDA also has a helpful portion on their website to explain what happens in a medical device recall. A recall can mean that a device just needs to be checked, adjusted, or fixed. Regardless, it seems like this information should contact companies, doctors, and patients as soon as possible.

Take a look at all the bill entails. Do you think this extra safety measure is a necessary step to further protect the public? Feel free to share your thoughts on these topics.

Photo Credit: OnTask

Topics: Medical Device Recalls, Medical Device Patient Safety Act, FDA


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