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Google Glass Making Its Way Into Operating Rooms
kkleiner writes "Among the possible uses for Google Glass that early adopters are dreaming up, you can now add 'surgical assistance' to the list. With approval from the institutional review board, a UCSF cardiothoracic surgeon recently utilized Glass during procedures by utilizing its voice activation features to refer to patient x-ray scans. Aimed at providing surgeons with the most up-to-date patient data, a startup named VitaMedicals is building apps to stream in patient records and live scans to the device. Even though it's early days for Glass, its potential in the medical space is huge and could revolutionize how doctor's access and apply information from patient records."
How much does Google stand to lose with something bad happens?
As they may get sued if there is a mess up.
This is probably years away, but if X-rays/CT scans/realtime data/etc. could be turned into a 3-D image, and the coordinates of that image "georegistered" with the patient on the table, we'd have an AR system capable of overlaying invisible information onto what the surgeon is sheeing as he/she operates.
E.g., superimposing the outlines of a tumor onto the surgeon's visual field "beyond" the visible surface of the body, so that the surgeon sees exactly where to cut and how deep.
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How is this better than a huge-ass monitor?
And how do you sterilize them?
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I doubt it, all they have to do is state that they never intended it for medical use. So long as they don't advertise it as such, they're fine, any liability is on the doc and/or hospital.
From the bacteria, or the advertisements?
You can hold down the "B" button for continuous firing.
Normally there'd be a computer, and the doctor would shout directions to a nurse that would bring up the images. The screen is not a "medical device" and if the computer crashed, it wouldn't bring liability on Dell or MS. It isn't a "medical device" but an imaging device.
Holding Glass liable in that situation would be like suing Nike if the doctor tripped over his laces, as I rarely see doctors barefoot, shoes must be medical devices, right?
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Anyone who trusts consumer hardware + OS as sufficiently robust to deliver faithful medical imaging in the middle of an operation is off my list of doctors I want operating on me.
So changing from Windows 7 with an imaging program to Glass is a step back? And Win7 with a commercial imaging program was a step back from having to mess with a pile of printouts? You want the surgeon focused on the patient, with supporting information available, not focused on accessing the supporting information, with breaks to cut on the patient.
Learn to love Alaska
Yes, he did look at the scans pre-op. And Glass can replace a screen that requires he turns his head away from the patient to look at it. If he's pinching an artery closed while working on a compound fracture, do you want him looking away from the patient while reminding himself where the cluster of bone chips are when the technology exists to overlay the information in his field of vision while focused on saving the life of the car-crash victim? Of course, he'll have the X-ray up at the same time, in case the Glass fails for whatever reason, but isn't getting the information within your field of vision better?
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How is this better than a huge-ass monitor?
Obviously there are some operations - especially in the US - where only a huge ass-monitor will do.
systemd is Roko's Basilisk.
I don’t know about you, but when I plan a road trip or plan to hit multiple locations in a single trip I plan out my route. I then check my route as I go along. Don’t do things on the fly, don’t do things from memory.
Most medical errors at not the big things, it is failing to execute on the small things. Checklist move anesthesiologist from one of the most error prone (i.e. high rate of malpractice suits) to one of the least error prone. (not sure if google glasses is the way to go, but it is intresting.)
Google isn't at risk as long as they are not selling it as a medical device. If someone wanted to create specific medical software for it they could but they would most likely need to file for FDA clearance. If something bad did happen, it would be on the entity that created the app and not Google.
If you display erroneous information the you will be liable.
Previous poster pointed out that this is true if sold as a medical device by an OEM. Medical device OEMs have a strict set of guidelines they need to follow for the creation of these devices--risk management, CAPA processes, demonstration that design outputs are tested against design inputs. (FDA 21 CFR Part 820, for example)
That being said, a hospital has a much less stringent set of requirements (though I believe there is much discussion in the FDA related to this). With the proper research agreements, IRB review (Institutional Review Board), and following proper research procedures (e.g. patient consent), a doctor can try new ideas, technology, or off-label use of existing device. However, Google would not be liable unless they want to sell a healthcare version.
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I have been involved with getting electronics into operating rooms, and it is an expensive, complicated and time consuming process. FDA requirements apply to all medical devices; with RFI being a big problem, especially in an OR environment (which is full of "mission critical" electronic gear). To be blunt, if Google glass interferes with the electronics already in the OR, patients could die, and everyone involved with getting it there would be directly responsible.
From my perspective, the note-worthy thing about this story would be getting the certification needed to take Google Glass into the OR, as that would probably be the hardest thing to do, much harder than some trivial HIPAA scrubbing, and it puzzles me that that is not mentioned in the article. So, I have to wonder, did they actually do this, or is Google and UCSF just winging it and hoping no one dies during their trials?
Why would it need to be sterilized? It's on a person's face, probably the dirtiest place in the OR. Or are you suggesting that we autoclave all the other surgeons' premium eyewear?
The disposable plastic face shield goes in front of the dirty bacteria-ridden face, glasses or not.
"Hi. You appear to be performing a heart transplant. Can I help?"
Easy. Far fewer disruptive head motions.
If my surgeon is deep into my chest cavity, I'd like him to have as much information on a heads up display as possible. Every repetitive head motion back and forth is a risk that a scalpel slips a bit as the rest of his body moves, cutting something important or just adding unnecessary lacerations to my insides.
Granted, robotic surgery is on its way. For the time being, though, there isn't anything quite as agile and responsive as a well trained surgeon's hands, even if he requires a bigger hole cut in my side to do it
As for sterilization, a combination of UV and being strapped to the head probably takes care of most of it.
You're correct. We have monitors all over the place. In the OR / ER / nurses station. We transmit patient data all of the time. Images / text. We buy whatever we need from the open market. I've had a bit of an issue getting IT not to buy the absolute cheapest panels on the planet, but anything mid spec these days is perfectly fine.
Anything electrical needs to pass some simple leakage tests, but our bio med tech does this on every piece of electronic equipment at least once a year anyway. But no certification is required.
Radiologist like these idiot expensive BARCO monitors (about 5 grand a pop). They have a 16 bit data path from the card to the screen (everybody else uses 8 or 10 except most laptops which are typically 6 bit paths) and do a wonderful job of greyscale display, but they're not 'medical' devices.
Faster! Faster! Faster would be better!
I imagine they'd be easier to sterilize than a huge-ass monitor.
Huge-ass monitor can be behind a glass screen. Blast it with some antiseptic, job done.
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I was under the impression that (US) doctors had to maintain medical record security. If Google is able to monitor everything the glasses are used for, how would this be possible?
But they are medical devices as they are diagnostic quality monitors. 5 grand a pop is cheap. Typically for a 5 Megapixel monitor pair and video card we would be 27 grand. The reason you need 5 Megapixel is because it is what is required by the FDA to interpret diagnostic mammography. The manufacturer has to show that the monitor complies with DICOM rendering standards and they have to be calibrated by a physicist regularly. For MRI, Ultrasound, and Computed Tomography (CT) a typical monitor can be used. Digital Computed Radiography (CR) aka Digital X-Ray, you need at least a 3 Megapixel monitor to properly display the diagnostic information contained in the images.
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Load up the images on SD card, and turn off transmit. What possible HIPAA issues could there be?
If you read the article, you'd know that the images were being "transmitted over wi-fi" during the surgery. I'm guessing that means they were on the guy's Google Drive; but in any case they weren't pre-loaded onto Glass.
And the article also talked about "manually scrubbing" all patient info from the images to comply with privacy guidelines. I have a hard time believing that would be enough - it's not like a surgeon does hundreds of surgeries in a day, it'd be fairly easy to match an image to a patient.
Me, next time I need surgery (hopefully not for a long while) I'm going to ask some pointed questions of my surgeon about this sort of thing beforehand. The concept is great, but I don't want Google to have my innards in their databases - I'm doubtful he's even thought about the bigger privacy picture at all.
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Sure thing.
Some rural hospitals used the flammables as late as the seventies, but by around 1980 (AIUI) they were pretty much gone. The texts from the era about how to ensure a spark-free environment are pretty interesting, though. Staff had small chains that dragged on a conductive flooring surface, you couldn't use cautery, etc.