[snip]
So you've got a case right there where being one step closer to the user gives you more insight into the actual conditions than some regulator had.
Now, I don't know sqat about medical equipment. But I'll assume that the primary concern is that the equipment not create a hazardous condition for the patient (or medical personnel). Blowing up an EKG machine was probably not considered a hazard. But I can think of a few failure modes involving a defib machine, unanicipated conductors attached to the patient, possibly hazardous 'sneak circuits' that could harm the patient or someone leaning on the connected EKG machine. Never mind whether the machine survives.