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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.
Now we have glassholes in the OR. Wonderful..
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.
Koans and fables for the software engineer
What's really in the "John Doe Xrays" folder?
Surgeons were one of the few who couldn't easily "multitask" on the job.
Let me also move my Cyber Monday surgery, just to be safe.
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.
It's not that I don't think the guy has backup in the event of total system failure (surgeons aren't generally that stupid, though other industries might be) - it's that I don't trust that there won't be something misleading caused by a bug. Hell, my idea of a malicious Glasses virus would be something that fools the user about what they're looking at, and while I'd want primarily hope it would hit hipsters in bars, who knows what mischief could be done in this case.
Medical software and hardware should be separately developed and certified.
So now instead of this we have this?
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.
HUDs in the OR open up a ton of possibilities, from easier and more intuitive arthroscopic surgery to better endoscopic exploration. X-rays and MRI results can be mapped to the body, eliminating the need to constantly glance at a nearby monitor. Vitals and other telemetry can be updated in realtime. Hell, remember when the whole "we're going to use sharpies to mark the correct surgery location" thing was a big deal?
This is a really interesting application, but I can't even begin to imagine the challenges with patient privacy on a platform like this.
Does Dell or HP get sued when there is an issue with the network or file servers at the hospital?
a UCSF cardiothoracic surgeon recently utilized Glass during procedures by utilizing its voice activation features to refer to patient x-ray scans
Shouldn't he have looked at those scans pre-operation? And people really think Google glass (a ui overlaying important, more relevant real life view) can replace a xray white board slightly to his left?
Are you implying that this type of technology would only be useful in male-to-female sexual reassignment surgery?
Medical software and hardware should be separately developed and certified.
Yes. Let's let a bunch of people die so that we can reduce the already microscopic risk of harm a bit further. Medical technologies are one place where we really, desperately need serious risk management.
I saw person-portable "heads-up displays" in Radio-Electronics magazines 15 years ago. What's different this time?
Finally, the NSA is really going to get up our asses.
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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So how are they going to sterilize it? It is a piece of commercial kit and should not come close to an operating theatre.
Excuse me, but please get off my Pennisetum Clandestinum, eh!
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.
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You are mistaken. A screen showing data and providing feedback to the surgeon is a medical instrument. It's the same a blood pressure monitor showing the sensor data. If you display erroneous information the you will be liable.
This will be great if it happens because maybe Google can convince FDA and ISO to tone down the stupid on their validation requirements.
In recent years, during doctor visits about 50-80% of their time was spent looking at computer (or tablet) screen, reading, typing etc. So the time actually looking at and/or examining the patient is already a minority. Add "Google glass" - and they are not really "looking at a patient" even when they do. Great.
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?
Learn to love Alaska
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.)
Uh, why would they even be responsible?
As they would easily laugh this out of court, google is also not someone you mess with legally.
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.
Medical software and hardware should be separately developed and certified.
Yes. Let's let a bunch of people die so that we can reduce the already microscopic risk of harm a bit further. Medical technologies are one place where we really, desperately need serious risk management.
No, no, no! The software and hardware ABSOLUTELY NEED TO BE developed and certified together. Otherwise you;re risking lives on some obscure undocumented incompatibility between disparate pieces.
this is why the doctor has liability insurance, if he does trip and stab the patient or look at a wrong chart, he is liable not the device.
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.
I love the sound of distortion in the morning -- webcommando
So the Dell screen I've seen in an OR is a licensed medical device because it could show medical information? I don't believe you.
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If they marketed it as medical-grade, I imagine they might well, yes. In this case, either Google is marketing Google Glass as medical-grade or, much more likely, doctors/hospitals have decided to use a non-medical-grade product as an aid in surgery.
What's the worst that could happen?
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?
Proprietary garbage should not have a place in such serious and important environments.
Surgical scrubs include shoe coverings that cover laces. Someone, somewhere, thought of that.
So how many lives are worth the few that might be lost on some obscure incompatibility? And next time you're in a hospital room, look at the equipment in the room. Do you really believe all that gear has been certified to work together? No, it's being tested on whoever is the patent in that room. And if something goes wrong, it'll eventually be fixed.
I see no reason to change my opinion.
Operations are complicated, messy, things, and surgeons are very interested in heads-up type displays to help answer questions like, "is my scalpel actually placed where I think it is?" Just like fighter pilots, they frequently do not want to take their eyes off of what they are doing. (I have worked in medical telepresence, and one of the things the surgeons most wanted was these kinds of headsup displays.)
"Hi. You appear to be performing a heart transplant. Can I help?"
is a good idea for Google glass.
No, but the software on it is. The Dell monitor was implemented by the solution provider and tested to be capable for the job.
Meh
Probably not much, as long as they got certified. From Justices Shield Medical Devices From Lawsuits
IANAL, this is not legal advice, etc.
Yeah. This is me taking out your spleen.
That's Nurse Ratchet juggling it.
Wait...that was your kidney...
Why are there two of them?
Oh crap!
Chas - The one, the only.
THANK GOD!!!
I don't believe you. When I looked, the only licensed software are the packages that include diagnostic functions. If it's purely a display, it doesn't need to be certified any more than the paper that holds the bill for your OR visit.
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> could revolutionize how doctor's access and apply information from patient records.
Is it really that hard to understand when and when not to use an apostrophe?
There's often no rhyme or reason or even logic to lawsuits, so the second point is null. The answer to your first point is "probably less than they make in like a nanosecond."
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!
All kinds of stuff in an OR is not certified for medical use - computers, keyboards, etc. As long as it doesn't touch the patient, that's fine.
Likely the software will have to be FDA approved under section 503 or whatever it is.
I'm sure many glass users will wind up in operating rooms for trauma treatment and rectal extractions.
Scruting the inscrutable for over 50 years.
With medical use the price of Google Glass was just adjusted slightly to $19,000.
Getting sued "if something bad happens" that isn't gross negligence on the part of the doctor is only a concern in the USA. The rest of the world with reasonable tort laws gets to use new technology to improve various procedures without worrying about lawsuit bingo.
I'd love to have a surgeon with an eidetic memory. Those are pretty rare, though.
For large sets, this will be our guide even unto death, for the LORD will work for each type of data it is applied to...
Isn't 503 for tax or something?
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Then it will "Never" be used in medicine, There are Laws/Regs. that "ANYTHING" used in medicine must be designed and more importantly carry liability Insurance from the Manufacture.
Are you certain they use off-the-shelf computers in OR's? Frankly I got out of the medical electronics business a long time ago, but I recall that any electronic equipment had to be designed so that there was no chance of it creating a spark and doing fun things with the flammable anesthetics. Sparks don't have to be like the things you get from Tesla coils. For example, switches (even relatively low current/voltage) can produce small sparks. You might not even notice if you were looking. Also, something like a component burning up in a power supply can be bad news. In a non-explosive atmosphere such things can often be contained with the appropriate use of materials, so the flame doesn't spread. In a potentially explosive atmosphere it's different.
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.
GENERATION 25: The first time you see this, copy it into your sig on any forum and add 1 to the generation. Social exper
I'm an anesthesiologist. I'm sure.
We haven't used flammable anesthetics in the US in a looooooong time. Newer ORs don't even have the "restricted to nonflammable anesthetic agents only" signs.
We haven't used flammable anesthetics in the US in a looooooong time.
Non-flammable? Wusses.
Like I said I got out of the medical electronics biz a looooooong time ago, and OR stuff wasn't our mainstay. Maybe even then it was a legacy thing in case somebody still had a few tanks of the good stuff lying around.
Thanks for the update.
FDA Section 503(c) is one (of probably many) regulations that medical device makers must adhere to in order to legally sell their medical devices for use in the USA. Not to be confused with any similarly numbered tax codes.
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.
Google Glass Seems to be a Great innovation in technology . if they can access all the patient data within the eyesight using google glass error free accurate operations could be possible which will directly result in high survival rate. we are surely entered in the advance future technology with google glasss
Google Glass's resolution is not anywhere near high enough for diagnostic imaging, doing this sort of crap would be illegal in most countries.
There's another startup - Pristine - based out of Austin, TX that's quite a bit further along than VitalMedicals. They've been piloting in live cases since early October. Their CEO said they've already run a few hundred surgical cases using their software.
Pristine is making teleconferencing / communication apps. HIPAA compliant 1st person audio / video streaming FTW.
I want to get my hands on them. I think they are going to change everything. Just think, no more selfies!
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.
As you said, there are regulations and guidelines. If erroneous information were displayed it would be the fault of the doctor for issuing a bad command, or the hospital for coding data incorrectly.
"ANYTHING"?
What about prescription glasses or lenses that a Docter might wear?
Google glass would be nothing more than a "display" for the doctor to look at, it would not replace anything in the operating room, it would merely add a convenience factor.