Slashdot Mirror
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.
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.
How is this better than a huge-ass monitor?
And how do you sterilize them?
No sig today...
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?
From the bacteria, or the advertisements?
You can hold down the "B" button for continuous firing.
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?
Learn to love Alaska
I imagine they'd be easier to sterilize than a huge-ass monitor.
But yes, they are no different than a monitor. I'm not sure why people are so frightened by a monitor. It is a voice controlled computer with monitor. So the doctor can do it himself (with voice commands) rather than bark orders at a nurse for what to display on the big-ass monitor. Or, in the old day, a separate table he had to look at with the printed materials on it, barking orders for someone else to change pages.
Learn to love Alaska
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.
Learn to love Alaska
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.
Yeah!
Hype, Hype, Hype.
Where is the product??
Is really another 1940's "Flying Car" scenario?
Yeah, you can make them, but there is no market for the damn thing.
(And they keep the hype up because they won't admit it is a market failure.)
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
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.)
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.
I thought the ass-monitor was post operation.
Shows what I know about medicine.
Careful with names containing L slashdot.org/~AiphaWolf_HK slashdot.org/~AlphaWoif_HK slashdot.org/~AiphaWoif_HK
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.
Learn to love Alaska
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.
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.
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!!!
With wipes - the glasses don't touch the patient. The point of the glasses is that the surgeon does not have to touch a computer, re-scrub, then return to surgery. The glasses are voice activated allowing the surgeon to interact with the software, then resume surgery without re-scrubbing. If the surgeon were to touch the glasses, they would have to re-scrub.
Meh
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.
Learn to love Alaska
> 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?
Mass produced flying vehicles are not feasible for a number or reasons, the least of which is technology.
Lets see, the amount of fuel needed will kill mileage.
I don't trust the way people drive on roads. Id hate to see the bad drivers when they have an entirely new dimension to operate in.
What about the specialized training needed for safe takeoff and landing.
WIll people be required to drive following roads, or just willy nilly over peoples property? What if they crash? Into your house?
I can't imagine the issues air traffic controllers will have to deal with.
I am sure there are plenty of other reasons I am missing too. Flying cars are a very bad idea IMHO.
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.
Probably keep it out of the sterile field, although systems like the Da Vinci surgical 'bots have sterile drapes since they have to be in the sterile field.
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.
auto-pilots are the answer.
aircraft mostly fly themselves already
some time ago a pilot in a newish passenger jet counted how many times he had to touch the controls in a flight from, i think it was, New York to London, he only had to touch the controls 7 times. and i assume part of that was telling the auto pilot where to go.
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.
No sig today...
Probably keep it out of the sterile field
It's on his face.
No sig today...
Is really another 1940's "Flying Car" scenario?
Yeah, you can make them, but there is no market for the damn thing.
(And they keep the hype up because they won't admit it is a market failure.)
No. "They" keep the hype up because there are still plenty of marks out there, willing to invest in flying cars. Paul Moller has monetized his Skycar for fifty years.
a huge-ass monitor.
I believe that would be a colonoscope.
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.
So would his corrective eye wear be. The concept of a sterile field isn't easy to grasp but the surgeons face isn't autoclaved either.
Very little is sterilized - most stuff is sanitized. Generally anything which touches the patient is sterile; the rest is sanitary. By their very nature most if not all ORs are impossible to sterilize. There are some cheap and effective measures which can be used but each also has its own drawbacks and gotchas, among them live steam, UV bath, ozone, and bleach and alcohol mists. It boils down to real-world realities, risks and costs, and practicality.
It's unfortunate state of affairs in that it's routine to administer a course of antibiotics post op. For instance, I've had four full-on procedures in the past year and was on a heavy regime of antibiotics after every one, with two infections acquired either from OR or hospital, and two that I had going in.
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?
Moderating "-1, Disagree" is simple censorship. Have the guts to post your opinion. -- Spazmania (174582)
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've had four full-on procedures in the past year and was on a heavy regime of antibiotics after every one, with two infections acquired either from OR or hospital, and two that I had going in
But do you know that those infections are due to the distinction in the OR between sanitary and sterile? Some countries (e.g. Norway, IIRC) have done a good job of reducing nosocomial infections. Have they done away with this distinction? If nothing else I heard that sheep dipping the OR personnel in antiseptic had some undesirable side effects.
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.
Da Vinci surgical 'bots
Or the TeleLap system. (For completeness' sake.)
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.
Nope, dunno. Without swab and such, no way to find out. Personally I think it would be of service to do so, but the matter of expensive time and testing would likely be brought up as a bar to it.
Generally, as I understand it, if sterile extends to what contacts the patient, all else is sanitized (this means knocking down any critter population to a level that is inconsequential (based on averages, perhaps, although that's a more forgiving measure than I'm prepared to accept out of hand), the basic isolation and shielding done viz. clothing and such, and decent air filtration ought by rights, one might think, be sufficient.
That it's not should maybe be looked into, I suggest. In real life nosocomials are more than trivially pesky, but if one thinks about the hospital as a place where you go to get an infection, they're downright silly to put up with.
Little things - having a pair of shoes worn only in the OR, kept in segregated locker space, might be good. I think some places do that - I've never asked and most people are too damn busy to answer stuff like that. Taking a post-shower nude UV bath might be good before donning clean scrubs, but what of those who are in the OR for five or six procedures per day? I can think of a number of possibles but don't know how they'd work out in real life. I think that bit of ignorance on my part should preclude the discussion, tho.
I'm only guessing but suspect most hospitals work within a set of guidelines and do their own cost-risk-benefit analysis. How good that is, and how inclusive (debility, readmission, fatality one thread to examine; there are others) I don't know. I rather suspect that bean-counters and lawyers make the final determination as to what is or isn't done. It's science-based, doncha know. (Too bad, no sarcasm tag.)
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.