Medical device use is rapidly moving outside hospitals and clinics. Changing use opens up the possibility of increasing patient comfort and convenience of treatment, with therapeutic and quality of life benefits. There’s also a reduction in hospital/clinic costs.
But we haven’t cracked the tough nut of how to adapt to this (relatively) new view of healthcare. New risks and challenges come into view as these devices are placed in the hands of people who aren’t medical professionals.
My gut feeling is that the pressure to crack this nut will become intense over the coming months.
That’s why I’m (Matthew) travelling to the US next week, for a meeting with AAMI and the FDA about just this topic. My particular interest is discussing the human factors implications, things like the design requirements, new risks and use scenarios (and of course potential abuse scenarios), what training and instructions need to do and how to deal with use errors away from immediate medical help.
As events unfold with the US government shut-down, will anyone be there from the FDA? I’ll find out next week!
It’s my third trip to the Washington area this year, so I’m starting to become more familiar with the place. If you’d told me two years ago that I’d be having these sorts of meetings with regulators, I wouldn’t have believed you. Yet here we are.