The Houston medical implant injury lawyers at Denena Points, PC have been discussing some of the dangerous down sides to medical devices. Sometimes they are poorly tested or not tested at all before being used as implants and surgical tools. Sometimes they have hidden defects or design flaws. And sometimes they’re used for unapproved purposes for which they’re not really suited.
But there’s another potential threat to your health from your medical device: hackers, malware, and the other dangers that routinely corrupt the other technological devices you might use. Just as your computer might crash from a stealthy piece of malware, so might your pacemaker. Or, imagine that the computer controlling a da Vinci robot was hacked just as a surgeon was using it to perform a heart valve replacement operation.
Our Houston medical implant injury lawyers have recently written about the large number of injuries and some deaths attributed to the robot and how those “adverse events,” as the FDA calls them, have been underreported. None of them that we know of have been linked to hackers or malware, but with the upsurge in cybercrime worldwide, it’s an increasingly likely scenario.
The growing reliance of the healthcare industry on technology coupled with the vulnerabilities of that technology, prompted the U.S. GAO in October 2012 to order the FDA to do something about strengthening security on medical devices. So the FDA has issued guidelines regarding stepped up security needs (which our Houston medical implant injury lawyers emphasize are not enforceable and have no teeth) to medical device manufacturers and the medical facilities that use the technologies.
And it’s not just medical devices, but other medical technologies that could be vulnerable. The dispensaries that prepare your medications and the software that contains your medical records (including allergy information and prescriptions you use) could also be corrupted. (Source: Willie Jones, IEEE Spectrum, 6/16/13) For instance, not too long ago, United Health group recalled its medical record software because it didn’t display crucial prescription data that doctors and hospitals need before they treat their patients. That particular problem appears to have been due to a flaw in the software itself, rather than a security breach. (Source: Wall Street Journal, Clint Boulton , 9/13) But as long as healthcare relies so strongly on technology, either is a possibility.
Click the link to learn about the FDA’s proposed security fixes to the problem of vulnerable medical devices.