In 2012, the FDA received detrimental reports of injuries, death and malfunctions associated with robotic surgery procedures that numbered more than 1,500, that number has increased to 3,697, an FDA official told Bloomberg News on November 8. This number may not be correct due to under-reporting.
The under-reporting is well known by the FDA, William Maisel, chief scientist at the agency’s unit that oversees devices said in an interview, “and the FDA is working to improve the system, even if there is under reporting it doesn’t mean you can’t draw conclusions from the data.”
“The adverse event reporting system is a disaster,” said David Challoner, vice president emeritus for health affairs at the university of Florida. “Every link in the chain has a reason not to report.”
There is an overload of complex medical devices in use. Intuitive Surgical Inc.’s da Vinci robotic surgery system helped doctors perform more than 350,000 surgeries in U.S. hospitals. This Intuitive Surgical Inc. (ISRG) system is linked to many different injuries. The FDA cleared The Intuitive system in 2000 after a trail run was performed on 233 patients in a Mexico City hospital.Shares for Intuitive have dropped 23 percent this year, it’s first decline since 2008.
According to Bloomberg, companies with medical devices are required to report any incidents involving their products. This has been in place since 1984. Hospitals are also supposed to report injuries and deaths, but the inspector generals office found the number of injuries reported by hospitals as low. In 2003, there were 823 hospitals that made at least one report. That number fell to 519 in 2007. That low number “raises concerns about potential under-reporting of adverse events,” the inspector general wrote.
The Institute of Medicine report concluded that reporting Flaws “make it impossible to confidently draw broad conclusions about the safety and effectiveness of products that are on the market.” Doctors training on the machine haven’t always been adequate said Enrico Benedetti, head of surgery department at the University of Illinois at Chicago. He also said doctors began using the robots on their own after a short course and operations supervised by experts.
Hospitals who purchased the robots were reporting fewer complications, without proof of a surgeon reproducing the same results as the robotic surgeons.
Reports of patients incidents involving the the devices of Intuitive are beginning to rise. In September 2012, The FDA is improving it’s monitoring of marketed devices by implementing a four-step plan, also the agency is sponsoring an international network of orthopedic registries to combine data.
“The only way we are finding out about a lot of these problems is through lawyers,” said Rita Redberg, a cardiologist at the University of California at San Francisco. “Too often, detecting adverse events associated with medical devices follows and unfortunate pattern, speaking generally about medical devices.” “We use for more medical devices than anyone else in the world and yet we can’t say what happened to these people. It is a really big problem and it is getting bigger everyday.”
In 2011, the FDA began looking into events associated with the Intuitive robot, after identifying some issues in reports. A warning was issued to the company in 2013 after an inspection found that the company didn’t adequately report adverse events and device corrections.
Challoner of the University of Florida said, “the ultimate goal would be to create a database that automatically downloads adverse event information from hospital electronic records into a giant database that scans for safety signals, providing a warning system that doesn’t rely on voluntary reports.
In September the FDA has finalized rules requiring all medical devices be identified by code, and the agency is updating it’s current database with newer versions with expanded capacities that are able to extract relevant information in an automated fashion.
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