FDA Trying to Safeguard Medical Device Software

Posted on June 22, 2012

As technology continues to advance more and more rapidly, there has been a deluge of medical devices that utilize complex software and programs to ensure that the products are going to work correctly.  But with these advances come tricky complications that are going to have to be overcome.

The Food and Drug Administration wants to better combat the threat that could be posed should a piece of software compromise the viability of a medical device.  The new effort to beef up safety and product quality will be conducted by the Office of Science and Engineering Laboratories.  A recent report that demonstrated unacceptable device failure rates was the impetus for the new initiative.

At the moment, the FDA uses a pilot system that allows them to determine and evaluate potential threats to safety that stem from the programming of a device.  Known as the Sentinel Initiative, work began on this system in 2008.  Since then, concerns about medical device safety have only increased.  Malware that targets medical devices is becoming commonplace, and demonstrations of how hackers could overwrite software show the vulnerability of the industry.

The FDA has stated their intention to continue to develop procedures that could better ensure the safety of the software within medical devices.  With more than a quarter of recalled devices owing their existence to an error in software, the increased emphasis on this topic is an important step.

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