Last year alone, doctors across the country performed more than 350,000 surgical procedures using the Da Vinci robotic surgery system. In spite of the prolific use of robotic systems, the federal administration still lags behind in collecting accurate information about the use of these devices and surgical errors resulting from such use.
According to a report recently published in Bloomberg, the Food and Drug Administration (FDA) is failing miserably in calculating accurate data about the use of robotic surgery systems in the United States. The FDA maintains a database of all injury reports, caused by the surgical system but the Agency has no legal authority to force hospitals or doctors to report any errors that occur with the use of the surgery systems or any injuries that result. Hospitals are required to report the number of errors that occur when using the systems, but they very often fail to comply with those rules. As a result, whatever data is contained in the FDA database is woefully inadequate.
According to the Bloomberg report, as a result of this failure to accurately report errors, there are an unknown number of injuries occurring around the country that never make it to the database. The Bloomberg report itself focuses on dozens of injuries that went unreported for many years while the Da Vinci robotic surgical system which was involved in the injuries, continued to be used.
According to experts who have been calling for a complete overhaul of the federal agency’s system for regulating and monitoring medical devices, the current reporting system is a disaster. The system is set up so to benefit companies by failing to report errors. As a result, there is widespread under reporting of errors.
Robotic surgery surgical equipment is considered a medical device and under a law that has been in place since 1994, all companies and hospitals are required to report to the database all injuries and deaths resulting from the use of these medical devices. However, there is widespread under reporting of adverse events, as can be seen by the fact that there have been continued declines in the number of errors that are being reported to the database. In 2007, for example, according to a report by the Department of Health And Human Services Office of Inspector General, there was a 37% decline in the number of injuries and fatalities that were reported to the system.
These flaws in the federal system need to be fixed, so that more accurate data about the use of robotic surgical systems can come out. In the absence of clear data, it’s hard to understand why these injuries are occurring, and what strategies can be used to help reduce injury or fatality rates.
The Indiana medical malpractice lawyers at Montross Miller Muller Mendelson Kennedy LLP represent persons injured as a result of medical negligence across Indiana.