Posted on 10/18/2024 8:09:43 AM PDT by BenLurkin
Over the last month, Horgan and other surgeons at the University of California, San Diego have performed more than 20 minimally invasive operations while wearing Apple’s mixed-reality headsets. Apple released the headsets to the public in February, and they’ve largely been a commercial flop. But practitioners in some industries, including architecture and medicine, have been testing how they might serve particular needs.
Horgan says that wearing headsets during surgeries has improved his effectiveness while lowering his risk of injury—and could have an enormous impact on hospitals across the country, especially those without the means to afford specialty equipment. “This is the same level of revolution, but will impact more lives because of the access to it,” he says, referring to his previous breakthrough in 2000.
A good mixed-reality headset, then, might allow a surgeon to look at a patient’s surgical area and, without looking up, virtual screens that show them the laparoscopy camera and a patient’s vitals.
In previous years, Horgan tried other headsets, like Google Glass and Microsoft HoloLens, and found they weren’t high-resolution enough. But he tested the Apple Vision Pro before its release and was immediately impressed. Horgan applied for approval from the institutional review board at the University of California, which green-lit the use of the devices. In September, he led the first surgery with the Apple headset, for a paraesophageal hernia. “We are all blown away: It was better than we even expected,” Horgan says.
(Excerpt) Read more at time.com ...
Ah... no thanks. I want my surgeons and pilots to use their eyes.
Can it be sterilized between cases (asking for a friend)?
Since it isn’t a med device listed with the FDA then it hasn’t been subjected to sterilization coming out of the box nor is it likely to be able to be sterilized by the hospital since most of them use only steam sterilization and this being commercial electronics is likely not sealed sufficiently and would likely require x-ray sterilization. (Ethelyne Oxide would likely oxidize the electronics and is unavailable at any hospitals I know of anyway).
Note: Apple isn’t claiming it as a med device and hospitals have a lot of leeway in what they use as they don’t fall under the FDA.
Surgeons use not their eyes a lot. Operating on really small things, laparoscopic. Hasn’t been just their eyes for 30 years.
It’s not touching the patient. It’s really just a monitor. A very small monitor “mounted” on the surgeon. Which have been in operating rooms for years. And I doubt regular glasses go through the sterilization you outline either.
Not surprised. Robotic assisted surgery is already going on so one can see where this is headed.
https://www.mayoclinic.org/tests-procedures/robotic-surgery/about/pac-20394974
I want my surgeons and pilots to use their eyes.
—
They are - you can see everything around you while using them.
It’s used in assisting treatment, doctor in the article even says as much, so it would be a device IF Apple claimed it as such per the regulations.
Mounted “monitors” are medical devices when used in operating rooms and claimed by the producer to be an assistance aid and/or ‘surgical room/clean room compatible’.
Been in the industry for 25 years working quality/regulatory issues. Don’t always agree with the regs, but if the company producing it claims it’s an aid in treatment it becomes a device.
In this case Apple doesn’t claim it...also why they refuse to claim any of the health benefits of the Apple Watch - despite it being better in many cases than other products out there claiming they are devices.
Ha! That's nothing! Check these out!
“Ah... no thanks. I want my surgeons and pilots to use their eyes.”
I want mine to use whatever enables them to do their best work.
It does not need “sterilized.”
Surgeons wear lights, and magnification all the time that is not sterile. Those are cleaned. The same cleaning would be good enough on the Apple device.
The resolution and cameras are amazing on it. While using it they can always remove it if they feel it is not working for their purpose. I think it is worth experimenting with the device and their surgical common and uncommon sense.
Dumb
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 :)
robots becoming more and more common in surgery.
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