| This is completely the wrong attitude. Different circumstances with different levels of risk, require the ability to adapt. Nobody is suggesting 'sharing ventilators' would be normal practice because in normal circumstances we want to make sure that equipment is 99.999% reliable. But as you imply, this requires extensive testing and regulation. Within these regulations are also significant safety margins that can be exploited if conditions change. If we can multiply the usage and maintain 99.99% reliability, then this is probably a risk worth taking. Also - if you've worked in the medical industry, you know how vastly overpriced and bureaucratized everything is. The situation of 'not enough ventilators' is literally happening right in front of us, and it is causing death. The risk tolerance for utilizing the gear in such a manner is such that it may very well be possible to create better outcomes. The individuals involved are medical practitioners who are well versed in the equipment, procedures, and inherent moral dilemmas, they're not fools. This is exactly the kind of procedural innovation required in times of crises - hopefully, a few doctors and especially the Engineers from the manufacturer can be involved. The people who built the gear may be able to give a much better articulation of the actual risks involved, and they may even be able to mitigate, for example 'the risk will be power consumption' or 'the risk will be this specific valve which could wear and break' thereby implying the 'new operational procedure' would involve daily checking of said valve etc.. The world is facing crises we absolutely must be adaptive while trying to quantify risk and outcomes. |
Quality guy here,though not in medical devices... Yet. Still trying to get up to speed on all the regulations; but I know enough to be able to vouch for some of the bureaucracy around the industry.
The risks in medicine being what they are, when launching into any novel space, there is simply no substitute for A) data and B) audit trail.
Your data varies from lot numbers of source material from suppliers (contamination happens), batch numbers of parts (and revision numbers of the process involved in making that batch) from manufacturers, to serial numbers matched up to individual patients in order to be able to implement some form of high-level statistical process control, and rapid intervention when things go wrong in order to figure out why, what you can do about it, and who else may be at risk. No one wants to be the one told "whoops, someone goofed, and that thing we put you on is trying to kill you," anymore than anyone in the chain from treatment inception, to installation wants to hear that they missed something, and even worse, get caught not knowing what to do about it.
That means paperwork, signalling mechanisms, and procedures involved with marshalling whatever response is to follow, which is not at all a trivial process to orchestrate, and while all of us wish there wasn't so much bullshit, there are plenty of examples where "falling asleep on the job" has led to catastrophic outcomes.
I can't necessarily say I that justifies the overriding though. The markups are ridiculous, but without access to the books, I can't really discount it either.