The da Vinci surgical system has been on the market for over a decade and has been used in more than a million surgical procedures during that time. Roughly 1400 da Vinci systems have been purchased by hospitals and the use of robotic surgery has increased more than 400 percent between 2007 and 2011. Worldwide, the number of robotic surgery procedures increased by eighteen percent in the first nine months of 2013 as compared to the similar time frame in 2012. It is used for such surgeries as hysterectomies, prostate cancer, head and neck operations and heart-valve procedures among others.
Since 1984, medical device manufacturers are required to report every death or serious injury related to their device to a database maintained by the Food and Drug Administration within 30 days of learning of the incident. Hospitals are also supposed to list injuries and deaths as well.
According to a study this past year by The Journal For Healthcare Quality, although thousands of mishaps were reported between January of 2000 and August of 2012, including 174 injuries and 71 deaths, researchers from Johns Hopkins concluded the mishaps appear to be vastly underreported when compared against news reports and court documents. One solution suggested by the researcher is the creation of standardized registries that track outcomes for all patients receiving these complex medical device procedures. It was this type of registry in Australia and Britain that led to our knowledge about failure rates of metal on metal hip devices.
The FDA announced a four-step plan in September of 2012 to strengthen our national system for medical device postmarket surveillance. In that plan the FDA noted that modernizing medical device postmarket surveillance is a long-term effort that cannot be implemented or achieved by the FDA alone.
With the number of robotic surgeries increasing and the nature of the medical injuries and deaths associated with these procedures, implementation of a better surveillance system cannot come soon enough.