Chicago patients may be harmed by medical error reporting flaws

Technological and medical advances have streamlined the work Cook County doctors and hospitals do. Surgical robots have been employed for more than a decade, particularly in less-than-traditionally-invasive laparoscopic surgeries.

U.S. Food and Drug Administration safety regulators monitor products, including medical devices, used to treat patients. Health care professionals and product manufacturers are responsible for informing the FDA about patient injuries and deaths caused by careless surgeons and product defects. A recent study criticizes the self-reporting method.

A Journal for Healthcare Quality report released this year indicated that federal officials may not be getting all the data they need to decide whether robotic surgical equipment is safe. The report focused on nearly a dozen years of adverse events reported about the da Vinci Robotic Surgical System made by Intuitive Surgical.

Study authors moved beyond accurately reported incidents to learn whether the FDA was hearing about every case of robot-related patient harm. The FDA recorded 245 adverse events with the da Vinci system, with 71 patient deaths. Researchers found another eight incidents; five had never been filed with regulators.

Intuitive Surgical took offense to the report. Officials indicated reporting protocol was followed for cases the robot maker was informed about by surgeons and hospitals. The statement seemed to point the finger at device owners and users for underreporting errors.

Researchers said they were concerned the FDA could not evaluate the effectiveness of surgical robots, without accurate reports of problems. The public makes personal health care decisions based on the FDA’s safety recommendations and warnings.

Surgeons and hospitals may be motivated to downplay or underreport mistakes for obvious reasons. Health care providers risk damaging reputations and finances.

A robot can’t be liable for surgical errors but owners, operators and manufacturers of robotic equipment can be. Doctors must disclose risks before performing surgeries, so patients can make informed choices. Device makers are responsible for product defects that cause patient injuries or deaths.

Source:  pbs.org, “Mishaps and deaths caused by surgical robots going underreported to FDA” Marissa Evans, Nov. 01, 2013


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