Consumer ultrasound: Dangerous & irresponsible?

By: Brian Dolan | Feb 18, 2010        

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Brian Dolan, Editor, MobiHealthNewsWill patients ever use handheld ultrasound devices at home? Some sonographers believe that’s idiotic, moronic, dangerous, highly irresponsible, “right up there with in-utero glamor shots,” and “the worst idea I have heard of.”

The consumerization of medical devices, however, is a common vision for the wireless health industry. For example, the Bluetooth Special Interest Group recently predicted Bluetooth-enabled stethoscopes like 3M’s will be available for consumers to use at home in the coming years. 3M, however, said it had no such plans just yet.

Late last year GE Healthcare unveiled its ultra-mobile ultrasound device, Vscan, at a pricepoint of less than $8,000. A few months later the West Wireless Health Institute’s Chief Medical Officer Dr. Eric Topol told attendees at the Consumer Electronics Show that in a few years patients would be using similar devices at home to scan their own heart ECHOs, which they would then send to their doctor.

That vision also includes connectivity with a medical professional who analyzes the data, and, as noted above, some of those tasked with analyzing this data are far from bullish about it.

GE’s Vscan officially launched this week thanks to recent clearance from regulatory bodies, including the FDA. Our coverage of the launch generated a number of fiery responses that we traced back to a discussion board on the Society of Diagnostic Medical Sonography’s website. SDMS is an association for medical professionals who use sonography or ultrasound technologies to perform diagnostic testing for patients.

UPDATE: To be clear, GE Healthcare has not suggested that consumers use the Vscan device at home. Here’s an official statement from the company that hammers this point home: “GE Healthcare’s position on Vscan use is that GE Healthcare does not support the usage of GE Healthcare Vscan for anything other than bona fide medical purposes pursuant to a physician prescription. Federal law restricts this Vscan System to sale by or on the order of a physician.”

Here’s more from the (uncensored) readers’ comments we received:

Rob Says: “This is by far the most idiotic, simplistic and deceiving medical article (advert?) I have ever read in my 33 year career as a Diagnostic Medical Sonographer. ‘People are going to be doing their own ECHOs and sending them to their doctors in the not too distant future,’ he predicted. Unbelievable. Yup, even simians can scan a heart!”

Dwayne Says: “Are you kidding me? This is right up there with inutero-glamour shots. It took me years of scanning just to begin to understand what is going on in the body, let alone grasp the conceps of ultrasound physics. To make this available to the public is the worst idea I have heard of.”

Norma Says: “Physicians returning to house calls is a wonderful thought and how nice for the patient. Patient’s scanning themselves? Um, no, never. What a ridiculous notion. Dangerous and highly irresponsible to even publish such rubbish. Thoroughly trained sonographers have YEARS of OJT by competent mentors, or anywhere from 18 months to 4 years of advanced training ALONG with 100’s of clinical hours. I want to know which one of these people who stated these quotes and put out this piece would be perfectly comfortable with their family member (being a layperson) scanning themselves and sending it to a cardiologist for interpretation and subsequent treatment based on that self-scan. Shame on you all. This is going to bring alot of negative light to a perfectly fine diagnostic tool, all in the quest for the almighty dollar. Money changer in the temple.”

Bill Says: “I would add similar to what several others above have noted, the notion of patients scanning themselves and having a physician diagnose based upon those images is moronic. I hope there are no physicians out there willing to do so. Fortunately this device being an Medical Ultrasound device, by FDA regulation is only to be bought and used by Physicians and/or medical facilites. Hopefully this regulation will prevail, and the FDA will be granted the Teeth to be able to enforce it. The more products like this that are introduced, being so small and (relatively) inexpensive the more you will see lay-persons try to be their own Doctor. They will be sadly mistaken once they try and find they don’t know up from down. Now the next thing is we need licensing which requires competency bar exam (ARDMS, CCI) in order to practice. There are too many Psuedo-Sonographers out there already, we don’t need every Joe Schmoe doing medical ultrasound too, furthermore, this would just increase our already overburdened workload with unnecassary testing because “hey Doc I got this new toy and I saw this thingy and it really looks bad”. Half the Doctors that refer to us already don’t really know what they are looking for, we don’t need more nightmares.”

Eric Topol Says: “I am surprised about the harsh comments above regarding patients acquiring their own ultrasound and transmitting the image to their physician. This is how screening for breast cancer will be done someday in the future, as ultrasound is an order of magnitude more sensitive than mammography. For patients with congestive heart failure who develop symptoms, this would be invaluable to sort out the actual cause of decompensation. The comments above do not give adequate credit to consumers who can be quickly taught how to properly place an ultrasound probe on their body and acquire a suitable image. This has nothing to do with interpretation of the image. In the future these naysayers will figure it out thanks to consumer driven health care. The same response was mounted many years ago when home external defibrillators were being developed. Now these are widely used with the right patients and in the right circumstances.”

What’s your take? Will medical devices like ultrasound machines and others find their way into consumers hands? Or is that vision an irresponsible and dangerous one? How do we (safely) get there?

In Other News: I am happy to announce that I will be participating in a live video webcast with the American Telemedicine Association’s CEO Jonathan Linkous next Friday, February 26 to discuss “Emerging mHealth Markets: The World of Health and Medical Apps.” I will discuss some of the topline results from MobiHealthNews first research report, “MobiHealthNews Presents: The World of Health and Medical Apps.” The webcast is free for ATA members and $40 for other attendees. Register Here

  • Dan Merton

    The sale and use of ultrasound technology is currently regulated by the FDA – and for a good reason.
    The issue is not about the ability of the lay-person to learn how to do a scan, nor the transmission of the data for expert interpretation. Who is to say that the lay-person will always rely on the expert’s opinion or even sends it to them at all? If they were to attempt to interpret the data (which is inevitable) it could lead to unneccessary anxiety and additional testing from a false positive scan (thinking something was abnormal when it wasn’t) or a false sense of security from a false negative scan (if there was an undiagnosed abnormality). Just imagine this technology being used by a hypochondriac or other individual with a high level of anxiety over their health or that of their fetus…

  • PirateRo

    How on EARTH does anybody pay you for a review? How is the use of a medical device “one of the worst ideas you’ve ever heard?”

    What is needed is a reviewer of some substance to provide clarity of thought that best expresses that monitoring – constant monitoring – is the best possible way to spot deviations and the best possible way to stay ahead of a problem. This child has NO BUSINESS evaluating new technology, much less in a contextual frame he clearly does NOT understand, does not appreciate and cannot wrap his head around.

    The next thing you’re going to tell me is that you can’t sterilize aluminum or glass or that you want a camera in a device that already supports bluetooth – because you can’t wrap your head around the actual core technology presented.

    Principled argument is obviously beyond you.

  • Tired of being overcharged for routine procedures

    Methinks the lady doth protest too much.

  • David Albert, MD

    Consumers buy and use blood pressure monitors, heart rate monitors, glucometers, and pedometers. Saying that ultrasound will join these consumer health products in the near future is hyperbole but those who say it is “crazy” are not correct. Ultrasonography is a profession today and the technology is used to look almost every part of the body- both from the inside and the outside. Fetal Dopplers devices are sold to consumers now so that parents-to-be can listen to their baby’s heart beat. some may consider this akin to the in-utero glamor shots but most pre-natal ultrasound ends up with a nice 3D rendering of the baby for the parents to keep. I can see patients being prescribed and trained to use a simple dedicated device to monitor a chronic condition but the costs will have to come way down for that to be a real market opportunity. What V-scan does is show us that the technology will continue to shrink.

    Now, as to Paul Jacobs saying that stethoscopes will become buggy whips– that is pure nonsense and you should not expect a man with a PhD in EE to understand that listening to the lungs or the gut or the heart or the neck arteries provides useful screening information at a great price. 3M’s new BT stethoscope and other electronic stethoscopes continue to improve what can be gained from auscultation. Take a look at what Inovise is doing with ambulatory heart sound monitoring. Inexpensive medical technology is coming and will find a place in both the first and third worlds.

    Civility should reign in any discussions but uncivil discourse is what the real-time online social media world gives us and it is not going to change. Calling people stupid or children has no place in these discussions.

  • Rod

    Obviously no one should be suggesting that an untrained person could always detect things that could be seen by a trained operator however:
    1) Tomorrows devices will be a magnitude more sensitive than currently and it is *very* possible that this will make up for reduced training.
    2) I am just interested in what the inside of my body looks like, just for novelty, why should I be told I cannot have a device because I *might* try and use it for diagnosis…
    3) Current devices are expensive and unoptimised because they have a very small and very high value market. Increasing the market could help to reduce the unit cost and improve availabilty to other countries which do not have the same finances and or trained operators.

    History is littered with examples of jobs where current workers rubbish future developments saying that nothing will be as effective as they are… only to find themselves left behind as others have moved with the times.

  • Gary

    This is not in the least surprising: current practitioners just trying to protect their business.
    As technology progresses, the expert knowledge is captured and embedded in (automated and inexpensive) devices and systems. There are entire fields which were up-turned (and some eliminated) by technology in relatively recent times: in electrical engineering (analog circuit design being done in SPICE software vs old paper/pencil/slide rule/calculator), in optics (what used to be a black art/magic/religion of lens design requiring hundreds of thousands of man hours, now is an off-the-shelf affordable software packages, usable by relative novices), in mathematics (the old labor-intensive calculations and proofs are now handled ‘automatically’ with appropriate software packages, e.g. Mathematica), in publishing (and especially, printing).
    Medicine is next, as the incentives for its change, due to its high and rapidly rising (well ahead of inflation, may I remind you) costs, are very strong.

    Eventually most medical expert knowledge will be captured and disseminated. Where diagnoses were a supreme skill form, they will be based on panels of cheap (self-administered/at-home/over-the-counter) but quantitative tests, including genetic panels. There will be an over-reliance on tests, but they will be very cheap (and is happening now anyway).

    Sure, there will be a HUGE resistance from the practitioners, as their very livelihood will be threatened, but no one can stop progress (at least not for long).

    The remaining 1% of practitioners will be incredible experts whose intuition (read, life-long experience + genius-level IQ) will not be easily capturable or transferable, who will be sought after for especially tough cases, and who will command appropriate (read, very/astronomically high) fees for their expertise.
    The DYI/telemedicine technologies’ adoption will not come from the patients, though but from the payers, such as HMOs and insurance co’s: they have direct view to the costs involved and can put a dollar value on the technologies’ benefits. With their financial clout they will be able to face the medical practitioners’ (organized by then) opposition, which will be fierce, IMO.

    The ER/surgery/ICU/labor&delivery professionals would probably not need to worry in the immediate future. But any test-based/related specialties, such as endocrinology, optometry, ophthalmology (excluding surgery), cardiology (excluding surgery), nutrition, radiology, and the already threatened ultrasound are at risk, IMO.

  • kitty

    I imagine that it’s quite likely that ultrasound devices of the future will be better and easier to use, and it’s quite possible that a patient or a caretaker can be trained to use it. I also imagine a situation when it may be useful to monitor a sick individual for whom it’s an effort to go to a doctor.

    At the same time, as an informed layperson who understands that more testing is not the same as better medicine and that screening and tests have risks, I do worry about false positives, unnecessary procedures and overtreatment that may result from healthy individuals trying to use the devices on themselves because as PirateRo above they believe that the more testing the better.

    @PirateRo — if you don’t understand the risk of false positives, please google for “overdiagnosis”. Then maybe you’ll understand why routinely screening yourself for minor deviations may not be a great idea and why early detection is not always a great thing. In fact, for an example of early detection gone awry and causing more people to be harmed than helped, google for screening for neuroblastoma in Japan.

    No test is perfect, and many deviations are normal. If you discover some “deviation” on yourself, you go to a doctor, the doctor may send you for a biopsy. But biopsies have risks. If the rate of false positives on what you do is high, it is very possible that the risks of having a complication from diagnostic tests is higher than the chance of having found a problem early. For example, let’s say 1000 people used these devices and thought they found “something”. They call a doctor, and the doctor ordered a biopsy just in case (also to protect himself from a possible law suit). Let’s say a test ordered to further investigate your “deviation” has a 1/1000 risk of a fatal complication (possible with some tests). So no you get 1 person out of 1000 dead who wouldn’t have been without this continuous testing. Now, it’s possible that some other person finds something early. But keep in mind that even with proven tests that people do all the time right now, one often needs to screen a thousand people for years to save one person. But you are talking a completely unproven self-testing that may not even help even one person out of 1000. It’s quite probable that more people will be harmed than helped in this case.

    Incidentally, in many cases finding something early makes no difference.

    One other issue is overdiagnosis that exists with some of the current screening tests. Our bodies are really complex. Some problems are indolent and don’t ever cause problems if left undetected or even go away by themselves. Yet, there is no technology now that can easily determine which problem would go away and which would present problems. As a result, anything found is treated and treatment may have serious even life threatening side effects. But with recommended tests, there is data from studies available which at least proves that the test saves lives; it also gives some information about the rate of false positive and some even though not definite estimates of overdiagnosis. This allows to appreciate balance of benefits and risks. No such data is available for self-testing and the probability is much stronger that more people will be harmed than helped.

  • http://mobihealthnews.com Brian Dolan

    I don’t believe that anyone has misread any of this and been led to believe that GE Healthcare has announced plans to market Vscan to the general public, but to be clear: They haven’t. Here’s a statement from the company, just to hammer it home:

    “GE Healthcare’s position on Vscan use is that GE Healthcare does not support the usage of GE Healthcare Vscan for anything other than bona fide medical purposes pursuant to a physician prescription. Federal law restricts this Vscan System to sale by or on the order of a physician.”

  • lindak

    The widespread availability and use of portable ultrasound systems would put a lot of degreed and registered sonographers out of work. I personally would rather have an experienced sonographer perform a professional scan on me rather than relying upon my own limited knowledge to try to locate a pathology in my own body. Things in my body that may look abnormal to me probably are normal. Let’s leave it for the professionals, PLEASE!

  • I. Butler, RDMS ABD OBGYN

    NEVER, NEVER, NEVER would I try to obtain images of my heart to send to my doctor for interpretation and subsequent treatment. I AM an ultrasonographer working in general ultrasound. Cardiac ultrasound is remarkably complex. Even with the best equipment (portable equipment tends to be the worst equipment available) I seriously doubt that a patient could learn to scan their own hearts. I could be wrong, so I put it to the professionals that do them. I asked my colleagues what they thought and they agreed that they would not scan their own hearts, and which cardiologist/radiologist would trust the images obtained by their ailing/untrained patient. This can not be compared to taking your own blood pressure or glucose level, etc. This sounds ill-fated to me.