FDA Launches Investigation Into Widely-Used ‘Robot Doctor’ After Complaints Over Safety And Cost

Last month, ThinkProgress reported on the controversy surrounding the daVinci surgery unit, a high-tech machine that allows doctors to remotely conduct surgeries from the comfort of a computer screen through the use of robotic arms. Innovations such as daVinci, while holding promise for certain procedures, don’t always end up improving U.S. health care in the aggregate due to high prices, inadequate product testing, and aggressive marketing driven by profits. Now, with doctors’ increasing use and heightened awareness of potential safety and cost issues with the robotic unit, the Food and Drug Administration (FDA) is launching an audit into the product.

The Associated Press reports that federal regulators and some medical professionals are rethinking daVinci’s efficacy in the face of elevated costs and increasing reports of complications from the machine’s use as more hospitals purchase the system:

[The] Food and Drug Administration is looking into a spike in reported problems during robotic surgeries. Earlier this year, the FDA began a survey of surgeons using the robotic system. The agency conducts such surveys of devices routinely, but FDA spokeswoman Synim Rivers said the reason for it now “is the increase in number of reports received” about da Vinci.

Reports filed since early last year include at least five deaths.

Whether there truly are more problems recently is uncertain. Rivers said she couldn’t quantify the increase and that it may simply reflect more awareness among doctors and hospitals about the need to report problems. Doctors aren’t required to report such things; device makers and hospitals are.

It could also reflect wider use. Last year there were 367,000 robot surgeries versus 114,000 in 2008, according to da Vinci’s maker, Intuitive Surgical Inc. of Sunnyvale, Calif. […]

But an upcoming research paper suggests that problems linked with robotic surgery are underreported. They include cases with “catastrophic complications,” said Dr. Martin Makary, a Johns Hopkins surgeon who co-authored the paper.

“The rapid adoption of robotic surgery … has been done by and large without the proper evaluation,” Makary said.

daVinci was rushed into the market through the process of “premarket notification,” which allows manufacturers to bypass rigorous FDA safety testing by claiming that their products are similar to previously-approved devices. This isn’t to say that daVinci is inherently faulty — procedures such a laparoscopic surgery also had high associated costs and led to medical complications when they were first introduced, but were improved over time and are now common procedures.

However, considering Intuitive Surgical’s aggressive push to get hospitals and doctors to buy the units — a push that included greatly reducing mandated safety training in order to drive sales — it’s possible that daVinci didn’t go through the right amount of scrutiny before its release into the market. And as more and more hospitals declare their intent to use the system, the FDA’s investigation becomes especially important for patient safety and national health expenditures.