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Future medical robot safety requirements

posted Sep 14, 2015, 9:36 AM by Frank O'Brien   [ updated Sep 15, 2015, 9:21 AM ]
intuitive da vinci
Surgical robotic systems hold the promise of enhancing the capabilities of surgeons performing surgery with advantages such as smaller openings, and more precision. There can be less blood loss, improved clinical outcomes, and faster recovery. Rehabilitation robots can help with lifting and precise movement of patients.

On the other hand, there are new hazards, for which there must be acceptably small risk of injury. Hazards include:
  • Unintended motion from use error (complexity of user controls and lack of tactile/pressure feedback)
  • Unintended motion from technical faults in programmable control systems
  • Unintended motion from breakage of support parts
  • Instability of mobile equipment
  • Patient release after power loss or emergency stop
  • Floating applied parts becoming earthed by robotic arm
  • Infection from complexity of sterile drape procedures

mako stryker rio
In April, a joint IEC/ISO new work proposal was approved to develop a particular standard for surgical robots, and another for rehabilitation robots. The new committees are IEC/SC 62D and ISO/TC 184/SC 2, JWG 35 (Joint Working Group) for surgical robots, and JWG 36 for rehabilitation robots. The 1st meetings were held in Stuttgart, Germany in July, with about 10 more meetings planned before completion by November 2018.  The new standard for medical robots for surgery will be called, IEC 80601-2-77, Ed. 1.0.  The new standard for medical robots for rehabilitation, compensation or alleviation of disease, injury or disability will be called, IEC 80601-2-78, Ed. 1.0. 

If you're interested in contributing to this effect, contact your IEC or ISO national committee. You can ask to join the committee as a participating expert; or join a mailing list for the ability to comment on committee drafts. In the US, the person who coordinates IEC/ISO participation for medical equipment is Hae Choe, Director, Standards, Association for the Advancement of Medical Instrumentation (AAMI). Her contact information is HChoe@aami.org, Tel +1-703-253-8268, Fax +1-703-276-0793.

Frank O’Brien, founder of OBCM, is an expert member of JWG 35.  In 1998, Frank’s team evaluated the DaVinci surgical robotic system from Intuitive Surgical to the IEC 60601 series.  Frank and OBCM continue to be active with medical robots systems, helping a number of medical robot manufacturers with their IEC 60601 compliance. We’d be happy to help you speed up your IEC 60601 compliance..