Under-reporting of Complications from Robotic Surgery Puts Patients at Risk

Under-reporting of Complications from Robotic Surgery Puts Patients at RiskNot very long ago, say a couple of decades, “robotic surgery” (surgery performed with robotic equipment) was a topic for science fiction.

Today, in the United States, there are more than 1400 installations with robotic surgical devices and since the year 2000, more than one million procedures have been performed with robotic assistance.

The procedures cover everything from plastic surgery to hysterectomies and heart surgery – literally more than a 100 surgical procedures. In the last four years, robotic assisted surgery has grown by 400% in the U.S. and 300% internationally. Considering that surgery is inherently a risky business, how safe are all these robotic procedures?

The answer, according to Dr. Martin A. Makary, lead author of a report published in the Journal for Healthcare Quality, is – we don’t know.

According to industry statistics, only 241 incidents of complications (including 71 deaths) were recorded for the more than a million procedures since 2000. This is far below the rate of complications, about 30%, for manual surgery, which raises flags.

While it is true that robotic surgery, similar to laparoscopic surgery, is generally minimally invasive and in the hands of skilled operators can be quicker and more precise than typical ‘open surgery,’ it has significant drawbacks. The most important is probably the level of skill required to use the equipment safely.

“Robotic surgery” does not mean a robot performs the surgery. All robotic surgery is human guided. A specially trained team of surgeons – a primary surgeon trained for the equipment, sitting at a computer workstation controls the movement of the ‘robot,’ and a second or assisting surgeon at the patient’s side – plan and carry out the procedure. The robotic portion of the work is done by a robotic arm and hand, which is outfitted with a variety of tools. The primary surgeon uses video monitoring (and visual support from the surgical team) to position and move the robotic arm-hand to perform the surgical activity.

For obvious reasons, the robotic surgery is no better than the skill of the surgeon(s) involved. Like any complex skill – and this one requires a great deal of skill – experience and talent are necessary components for success. For equally obvious reasons, these requirements are not always met, which should mean that robotic surgery would have a similar complication record to standard surgery. The fact that the robotic surgery complication record does not, raises questions.

According to Dr. Makary, the questions center on the reporting system for errors and complications in the use of robotic surgery. In the current system, medical complications that occur because of robotic surgery are reported by the hospital to the manufacturer of the robotic equipment, which is for all intents and purposes a single company, Da Vinci Systems, Inc. In turn, the company is required to report all incidences to the U.S. Food and Drug Administration (FDA).  Part of the study conducted by Makary and colleagues at Johns Hopkins University School of Medicine, revealed that several incidents reported by the media were not found in the FDA database of robotic related incidents.

Likewise, some cases that were recorded in legal databases (from court cases) were also not in the FDA database. Dr. Makary noted that in a previous study 57% of surgeons surveyed anonymously reported operative malfunctions with robotic surgery. However, in most of these cases the surgeons converted to laparoscopic or open surgery to correct for the problems – and seldom reported the incident.

In the opinion of the report, and Dr. Makary, the incidence of complications with robotic surgery is significantly under-reported. This means that doctors cannot give patients accurate assessment of risks for various surgical options that include robotic surgery. It also makes it difficult for surgeons to absorb and react to difficulties in working with robotic equipment – improving on correctable mistakes – that is a vital part of mastering a new technology.

In Dr. Makary’s view, the line between errors caused by human judgment is sometimes blurred by the limitations of the robotic machinery. For example, in heart surgery the surgeon may often feel the condition of the aorta (the main artery) to assess its fragility or robustness, before attempting a valve replacement. This “touch” experience is subjective and surgeons sometimes misjudge the condition of the aorta, leading to a serious complication (aneurism or bursting). However, with the robotic ‘hand’ this degree of sensitivity is hardly possible at all, which of course, may lead to misjudgment. Where is the fault – in the relatively insensitive robotics or the surgeon’s judgment?

The Johns Hopkins study concludes that it might be better for the medical community to adopt a reporting system unaffiliated with the manufacturer, such as the database of surgical complications maintained by the American College of Surgeons, where independent nurses identify and track adverse events resulting from traditional operations. The impartiality of the approach should encourage improvements in the technology, while not misleading patients about the risks involved.

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