FDA says da Vinci robot adequately addressed risks

The U.S. Food and Drug Administration last week declared the maker of the Da Vinci robot surgical system has adequately addressed violations the agency pointed out last summer, MedScape reports.

In a letter dated April 25, 2014, an FDA compliance officer informed Intuitive Surgical that "the company's corrective actions in response to the 2013 warning letter appeared to pass muster," the article notes.

The FDA accused Surgical, the manufacturer of Da Vinci, of neglecting to report "field actions" it took to prevent patients from accidental electrical burns.

The jury's still out on the efficacy of robotic surgery. A recent study published online in the Journal of Clinical Oncology found no clear winner in the robot vs. surgeon game. Robot-assisted radical prostatectomy (RARP) led to complication rates, readmission rates, and rates of additional cancer therapy similar to those of conventional surgical prostatectomy, a review of almost 6,000 cases showed, MedPage Today reports.

"RARP and open radical prostatectomy have comparable rates of complications and additional cancer therapies, even in the post-dissemination era," Quoc-Dien Trinh, M.D., of Dana-Farber Cancer Institute in Boston, and co-authors concluded. "Although RARP was associated with lower risk of blood transfusions and a slightly shorter length of stay, these benefits do not translate to a decrease in expenditures."

Hospitals have been accused of hyping robotic surgery while downplaying the risks. Johns Hopkins research found it much costlier than minimally invasive laproscopic surgery on the colon, but providing no great advantage to patients. The American Congress of Obstetricians and Gynecologists issued a statement saying it's not the best choice for routine procedures.

Robotic surgery also made FierceHealthIT's list of five overrated, overpriced healthcare technologies. This fall, the ECRI Institute ranked robotic surgery as No. 9 on its Top 10 health technology hazards list, pointing out there are no widely recognized requirements for robotic surgery training and credentialing programs.

While the Da Vinci surgical system is the only robot with FDA approval--and the target of plenty of criticism--researchers are looking to develop surgical robots based on open source technology, reports Scientific American. Taking a page from software development, it would involve a basic design that wouldn't change from device to device as well as community of developers to improve it and create their own innovations.

To learn more:
- read the Medscape article (login required)
- read the MedPage Today article
- see the study in the Journal of Clinical Oncology (subscription required)

Suggested Articles

Premera Blue Cross will pay $6.9 million to HHS over a data breach six years ago that exposed 10 million people's health information.

United Airlines is working with health company Color and GoHealth Urgent Care to roll out the first COVID-19 testing program for air travelers.

The potential long-term impacts of COVID-19 on how Medicare Advantage's star ratings are calculated remain unclear, experts say.