NEW YORK — A rising number of reports about deaths, injuries and malfunctions linked to the robotic surgery system made by Intuitive Surgical may pressure hospitals to bolster training for doctors using the $1.5 million device.
The Food and Drug Administration received 3,697 adverse event reports through Nov. 3, compared with 1,595 through all of 2012, an agency official said in an interview last week. While the FDA said the surge may be tied to added public awareness from more use of the machines or recent media reports and recalls, a survey of surgeons released the same day suggested the complex robot interface was a challenge to master and that physician training was inconsistent.
Standardized training on new medical technologies "is a systemic problem," said Robert Sweet, a medical training expert at the University of Minnesota, in a telephone interview. The spotlight on robotic surgery may help to focus needed attention on the issue, he said.
"Training for robotics has been the wild, wild west for a long, long time," Jeff Berkley, chief executive of Mimic Technologies, which makes simulators used for robotic training, said by phone yesterday. With patient lawsuits on the rise, hospitals and doctor organizations are realizing "they have to get their act together and start focusing on training."
The main problem will be how to pay for and oversee the training of widely scattered physicians, Sweet said.
The doctor survey released by the FDA on Nov. 8 included 11 surgeons who have performed from 70 to 600 robot surgeries each. While the physicians, who weren't identified, said the robots led to fewer complications and shorter recoveries, they also reported diverse patient problems. These included reversible limb palsy, temporary nerve damage in the fingers, bleeding from perforated bowels and peripheral vision loss.
Adverse incident reports can be sent to the FDA by companies, medical professionals and patients. While they are largely unverified by the agency, they can sometimes serve as a first-alert that U.S. regulators should look more closely at a product.