The other items, if devices, are sterilized prior to being introduced to the surgical suite and are labeled as such. Post use the term used is ‘sanitized and/or disinfected’ (unless they are cleaned and resterilized as much equipment is) and devices that claim they can be cleaned as such go through testing to prove it and validate the cleaning process - which are included in their service manuals. Failure to prove the process is validated or field issues resulting from improper cleaning can lead to recalls against the manufacturer by the FDA (of which I’ve unfortunately been a part for similar in the past).
Again - Apple doesn’t claim they are to be used as aids in treatments, diagnosis, etc so they aren’t medical devices. If they made the claim it would be required that they demonstrate the above.
Hospitals have a lot of leeway on what they use and aren’t regulated by the FDA - they have a different industry led body that drives their practices that require the review board (or similar) mentioned in the article.
I think it’s fine they are using them and encourage such experimentation - as I mentioned before I don’t always agree with the regs....but if Apple were to claim any of these uses then the regs would apply and it would be a different story...which is why Apple doesn’t make the claim.
Have a good weekend :)
I have seen surgeons many times wearing lights and magnifiers outside of ORs in the surgical area, even while scrubbing in.
Even eyeglasses that surgeons wear are not sterilized pre-op, though cleaning is common.
My only point is that just because the Apple product is not presently amenable to sterilization, which was mentioned, does not mean that it cannot brought into an OR and used on some capacity.
And in the instance described, the hospital also went through other procedures to validate using it.
This type of thing needs done in medicine. The FDA is already way too bossy.
You have a good weekend too!