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Phil Jacobus has been involved in health care since 1977, when he visited China to sell equipment. He has done business in 35 countries and still travels extensively. Phil is active in charity, helps rural clinics and always tries to help DOTmed users when he can.
Phil is a member of AHRA, HFMA, AAMI and the Cryogenic Society of America. He has contributed to a number of magazines and journals and has addressed trade groups.
Phil's proudest achievement is that he has been happily married to his wife Barbara since 1989, who helped him found DOTmed in 1998.
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Steven Ford
GE MRI recall
March 04, 2015 08:54
The problem is a serious one and a design problem. The FDA requires that a single fault in a medical device may not lead to a hazardous condition to the patient, the operator, or the public. Additionally, if there are two simultaneous faults that can lead to a hazardous condition but one of those faults can exist undetected, that counts as a single fault, as far as the design safety analysis.
Every day there are people somewhere who bring metal near an MRI magnet. When that happens, the safety equipment has to work. The mistake of GE is that they designed the system so that the quench button could be disconnected and this is undetected. They will need to redesign and modify the MRIs so that they will work like Siemens and other manufacturers do--the machine will not run, or will prominently display an error, if the quench button is not hooked up.
I was in India recently and asked a local engineer about this. He said it was very common not to hook up the quench button. I've seen it on more than one site in the USA, too.
Of course, people are dumb if they bring metal into the magnet. But there are plenty of dumb drivers out there,
and we expect the seat belts to work when we need them.
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