[unclebilly]

Originally Posted by Mahler9th

The laws in place regarding medical equipment and devices are well known to me-- perhaps not many of you. At the center are safety and efficacy.

Some of the laws have to do with proving safety and efficacy sufficiently to obtain an FDA clearance or approval (which one of these applies depends on a number of factors-- new types of vents are likely in need of clearance).

Others have to do with process-- the manufacturing process, which in itself may require approval(s) before anything can be sold and used on a patient.

I can envision the potential for some relaxation of legal/regulatory structure for the manufacturing of some types of devices and equipment in the face of a global pandemic... so for example if we needed more tongue depressors, I can envision a relaxation of manufacturing requirements (yes those simple things are medical devices by law).

But for others, like vents, I see a rockier path toward relaxation of US laws and regulations-- especially with our legal system.

In some ways these machines are simple, and in other ways they are complex. But the safety and efficacy of vents is absolutely critical given how they are used in healthcare. So relaxing any laws and/or regulations regarding design and/or manufacturing is likely fraught with peril.

So in this country at least, it is hard to envision a relaxation with respect to machines like vents.

But at this point I would not be surprised... this is all new territory. And some of this new territory may require new laws soon or eventually.

For the record, if things go badly for me, I would rather have a functional vent than not be able to get access to a FDA approved vent.

The purpose of this thread is to develop something for use in an emergency situation, not something for used or sale on the open market in normal circumstances.