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September 2013 Archives

FDA addresses medical device safety issues

Many medical devices involve embedded computer systems that are vulnerable to cybersecurity breaches - like computer viruses and malware. Of course, for New Jersey consumers this may present privacy concerns, but many people may be less aware that lax cybersecurity standards among the makers of devices can greatly affect patient safety.

Robotic Surgery Injuries Underreported

Robotic surgery procedures have increased dramatically since they were first approved by the FDA in 2000, and so have the percentage of patients who have been injured by them. There are 2000 da Vinci systems installed in the US medical facilities today and 367,000 robotic procedures were done in 2012, mostly for gynecologic and urologic procedures with hysterectomies and prostatectomies accounting for the vast majority of cases. But while the percentage increase in the number of surgeries between 2011 and 2012 was 26%, the number of adverse events to patients increased by 34%, with a total of 282 robotic surgery injuries last year. Even more troubling is that a study in the Journal for Healthcare Quality reported that the number of reported injuries in 2012 only represent a small fraction of the actually injuries that occurred. The study found that a number of adverse events were not even reported.

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