Medical devices and aircraft should NEVER be the exemptions.
Those are two category of product that have one of the longest lives of consumer goods, and have serious external guardrails and regulations around their safety.
There are MANY 50 year old aircraft flying around still, the average GA fleet age is 35+. Part of that is that replacement parts are approved by the FAA, and not the OEM. If the FAA says I can use an Garmin transponder in my Cessna, Cessna can't brick my plane even if they have a deal with Icom. There are still aftermarket parts being sold for models that were discontinued in the 1950s. Imagine if we had to throw away every old airplane when the manufacturer went bust.
Medical devices are the same, if a third party manufacturer is selling an FDA approved replacement battery for an older hearing aid, I would be pissed if the manufacturer bricked my device for not using their battery. Or even worse, how mad would you be if the original manufacturer, and the secret signing key for their batteries, went out of business and you didn't even have the option of an expensive OEM battery.
> Medical devices and aircraft should NEVER be the exemptions.
> "if a third party manufacturer is selling an FDA approved replacement battery for an older hearing aid,"
The FDA and FAA are massive bureaucracies that are not going to get into the business of regulating electronics. Practically, medical devices and aircraft should be exempt, as things are today. Suggesting legislation should be written otherwise, is negligent at best and malicious at worst.
> The FDA and FAA are massive bureaucracies that are not going to get into the business of regulating electronics
The FAA has been in the business of regulating electronics for more than half a century. They are also in the business of certifying that replacement parts meet the same standards even when not endorsed by the manufacturer. There is a reason that a 1970 Cessna can have a modern avionics suite.
Medical devices include the likes of x-ray machines. I don't think I would relish the idea of my dentist saving a buck on maintainance and calibration. I think a more precise follow-up bill that covers things that aren't life threatening (like hearing aids) would be more appropriate.
Forcing an x-ray to be serviceable is not the same as making it legal for an amateur serviced machine to be used.
There are also all sorts of existing legal remedies for things like this. If you blast someone with x-rays through negligence like letting an amateur fiddle with the x-ray machine, you will have some serious legal issues regardless of whether or not the OEM is legally required to sell replacement parts.
You can have one law that says that medical machines must be repairable, and then you can have another law that says that medical machine repairers must be trained, or that repairs have to be inspected.
This is already a common thing in life or death services, yeah, anyone can do the work to wire their own house (since its an open standard), but that doesn't mean that a qualified electrician and inspector doesn't have to put their names that the work has been done to a safe standard.
>anyone can do the work to wire their own house (since its an open standard), but that doesn't mean that a qualified electrician and inspector doesn't have to put their names that the work has been done to a safe standard
That is not universally true in the US--and is probably widely ignored even in jurisdictions where it is theoretically true.
Would the availability of such things as documented, published, manufacturer-supplied methods for maintenance and calibration of dental x-ray machines increase the likelihood of your dentist trying to save a buck on these tasks, compared to the unavailability of these things?
I'm pretty sure malpractice insurance would love to not pay the doctor if they are caught doing anything like this. That threat alone would prevent doctors from doing stupid things.
To heck with that. My right to reverse engineer and fabricate parts for an airplane that I own is ALREADY enshrined in federal law, and our aviation user groups are funded and motivated to protect this privilege. It is as applicable to American Airlines (they have used it, for example, to produce replacement MD-80 tailcones) as it is to a dude with a Cessna.
What are your thoughts on the artificial eye company that shut down, possibly leaving patients with non-working and non-repairable implants in their head [1]?
