Morning: the last session of the HFES Healthcare Symposium. I chose to go to the presentations from three people from the FDA, who were all presenting different aspects of the Human Factors regulatory system. As an outsider to the system, I found this very striking for at least two reasons:
1) Tony Watson presented a pretty frank history of human factors in the FDA. Medical Devices are, of course, not a central focus for the organisation, but there has only been one HF specialist in the FDA for 15 years... and only two (and a couple of other people whose primary responsibility lies elsewhere) for the past 4 years or so. That's it! Those two people set policy and direction for the US... and the US, in turn, sets policy and direction for most of the rest of the world. That gives those two people more power and responsibility (and a much bigger workload) than I imagine they want. Last week, one of the people I was working with introduced me to a new acronym: PAMP: Problem Above My Paygrade. It seems to me that the HF folk at the FDA are dealing with a PAMP in spades!
2) They were all here! The key Human Factors specialists at the FDA, who set policy and manage practice in the regulation of all interactive medical devices, were at a conference that involved manufacturers and usability specialists and academics. And they were around to chat, to listen, to engage with their community. As a British researcher, I have better contact with the people who regulate medical devices in the US than I do with any such people in the UK.
Lunchtime: I gave a talk at the Armstrong Institute of Patient Safety Grand Rounds. It was in a large and imposing lecture theatre in the Johns Hopkins hospital, and felt quite like an inaugural lecture, except that half the audience were wearing scrubs and surgical masks.
Afternoon: meeting with Chris Gibbons, who is studying how to use new technologies to make healthcare more accessible to disadvantaged communities in the US. Baltimore is, of course, a divided city where a significant part of the community needs better access to healthcare, while much of the rest has excellent access. So a great place to do such studies.
1) Tony Watson presented a pretty frank history of human factors in the FDA. Medical Devices are, of course, not a central focus for the organisation, but there has only been one HF specialist in the FDA for 15 years... and only two (and a couple of other people whose primary responsibility lies elsewhere) for the past 4 years or so. That's it! Those two people set policy and direction for the US... and the US, in turn, sets policy and direction for most of the rest of the world. That gives those two people more power and responsibility (and a much bigger workload) than I imagine they want. Last week, one of the people I was working with introduced me to a new acronym: PAMP: Problem Above My Paygrade. It seems to me that the HF folk at the FDA are dealing with a PAMP in spades!
2) They were all here! The key Human Factors specialists at the FDA, who set policy and manage practice in the regulation of all interactive medical devices, were at a conference that involved manufacturers and usability specialists and academics. And they were around to chat, to listen, to engage with their community. As a British researcher, I have better contact with the people who regulate medical devices in the US than I do with any such people in the UK.
Afternoon: meeting with Chris Gibbons, who is studying how to use new technologies to make healthcare more accessible to disadvantaged communities in the US. Baltimore is, of course, a divided city where a significant part of the community needs better access to healthcare, while much of the rest has excellent access. So a great place to do such studies.
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