FDA workshop on medical robotics standards

Robotic devices should provide significant patient benefits and allow for refined treatments that are not possible by other means. It is crucial to test for the application accuracy of a system, to define the expected overall task execution error. After 20 years of development, there is still a great need for objective measures in medical robotics.
Realizing this fact, FDA organized a workshop on Medical Care Robots in mid-February inviting over 60 professionals to discuss the ontology and definitions of medical robotics in order to develop standards for application safety and risk management. "The meeting, which was only a first step in what might be an on-going process, was intended to coordinate efforts already going on in standards-setting organizations, which would supplement pre-existing generally-applicable standards at the FDA... Part of the group’s work will consist of identifying gaps in existing standards posed by the emergence of medical robotics technology. One example might be where the computer of a surgical robotics system freezes up in the midst of a surgery."
"A new amendment to ANSI/AAMI ES60601-1:2005 is under development, including a definition of medical software systems and associated technical requirements, streamlining the application of risk management, ... and clarifying the definition of essential performance to more fully explain the process for identifying essential performance and mitigating the risks associated with its loss or degradation. The amendment is expected to be published in August 2013."
A focus of the workshop was to find universal definitions for different medical robots and CIS systems. Intuitive recommended the following grouping:
  • Surgical assist devices (scope positioners)
  • Surgeon augmentation devices (enhance skills, eg: da Vinci and guided catheter systems)
  • Caregiving augmentation devices (remote presence, physical therapy, play therapy)
  • Hospital augmentation devices (pill dispensers and transport systems)
  • Patient augmentation devices (bionics and exoskeletons)
  • Decision support devices (remote presence, medical diagnosis)
  • Autonomous action medical devices (smart artificial pancreas)
  • Autonomous care-giving devices (robotic wheel chairs, feeding and bed turning)
The next meeting could take place this year, but probably not before the fall.

Sources: AAMI press release, Everything Robotics Blog, Medical Robotics Blog Learn more about "the need for accuracy standards in CIS" through our paper intended for the EURON GEM SIG Workshop at ICRA.


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