Joint Working Group of Standards Organizations Meets to Define Medical Robotics

by John Otrompke

A joint working group of two standards-setting organizations, the International Standardization Organization (ISO), and the International Electrotechnical Commission (IEC), met in Nuremberg, Germany for the second time last month to establish definitions for medical robots, as another step in creating standards for the design and manufacture of the devices.

While medical robots are thought as a preliminary matter to include aids for the disabled, as well as those which perform invasive and non-invasive procedures such as surgery, rehabilitation therapy, imaging and other robots for medical diagnosis and treatment, a number of theoretical issues remain undetermined, according to Gurvinder S. Virk, PhD, who chairs the entity, which is known as joint working group nine.

Distinctions in terminology could be important, according to Virk, who is also a professor of robotics at the University of Gävle in Sweden. “Up to now, robots have been classified as machines, and are therefore governed by machinery directive, established by the European Union.” 

Among other categories include personal care robots, which an an individual uses to help himself or herself without any kind of medical connotations, Virk added. “Some devices, such as assistant exoskeletons such as a device called E-Legs which is available in the U.S., or the HAL (hybrid assistive limb), by the Japanese company Cyberdyne, help old people move about, but the medical people on our committee say that getting old is not a medical issue.”

Virk is also the founder of CLAWAR, the association of Climbing and Walking Robots, which is incorporated in the UK.

“What’s the difference between medical equipment and a medical robot?” Virk asked. “It seems to me to be autonomy, whereas most medical equipment in current use does not have any autonomous functions.”

The distinctions can become thorny, according to Virk. “The da Vinci is able to filter out the tremor of the surgeon, and most people would argue that that’s an autonomous capability.” However, the FDA license for the da Vinci describes the device as an endoscope, not a robot, according to Virk.

The joint working group will next meet in February of 2012, in Orlando. Virk and colleagues are also planning an annual International Colloquium on Medical Robots, to be held next July in Milan, Italy.