An increasing number of Chicago surgeries are dependent upon precision technology. Over 350,000 operations last year were performed by surgeons, sitting apart from patients and guiding the “arms” of surgical robots. When surgical errors occur, the fault may be man- or machine-made.
The medical community has growing concerns about robot-assisted surgery mistakes and under-reporting of patient injuries and deaths. The Food and Drug Administration receives adverse event reports from patients, doctors, hospitals and device makers, but only manufacturers are required to report incidents.
Commonly, medical device failures remain uncounted until a manufacturer is contacted by lawyers representing medical malpractice or product liability litigants.
More than 3,600 reports about robotic surgical errors were reported to the FDA in 2013, well over double the number recorded the previous year. Federal officials have not determined whether humans or robots made the mistakes.
The FDA is not blind to the faults in its reporting system, although some medical specialists say that’s not the only problem. New medical devices, similar to ones already in use, often aren’t tested on humans the way medications are before receiving FDA clearance.
Doctor training on medical devices also may be insufficient, according to the head surgeon at Chicago’s University of Illinois. Some surgeons receive only a brief training period before employing the high-tech devices. The FDA does not make adverse event reports mandatory for doctors.
Federal officials have promised to step up medical device monitoring through international registries and a system for automatic error reporting. The FDA has ordered manufacturers to stamp devices with singular codes to keep track of equipment-related accidents.
Critics say the current, haphazard government monitoring system is likely to remain in place for years until a streamlined system replaces it. Until then, patient and plaintiff information about robotic medical equipment safety is heavily dependent on FDA error reports, which may represent only a fraction of device problems.
For those that have been injured or worse due to a surgical error from a robot, other machine or human, there are legal remedies available for the victim and his or her family. Experienced attorneys can help guide their clients through the civil process for seeking compensation for a variety of economic and non-economic damages.
Source: Bloomberg, “Unreported Robot Surgery Injuries Open Questions for FDA” Robert Langreth, Dec. 30, 2013
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Medical device monitoring flaws may endanger Chicago patients
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