A rising number of reports about deaths, injuries, and malfunctions linked to the robotic surgery system made by Intuitive Surgical Inc. (ISRG) may pressure hospitals to bolster training for doctors using the $1.5 million device.
The U.S. 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 Inc., 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.