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Robotic Surgery Complications Going Underreported
First time accepted submitter neapolitan writes "PBS has a report on the difficulties of tracking the complications arising from surgical robotic systems, particularly the Da Vinci robotic surgery apparatus. The original study (paywall) notes that there is a large lag in filing reports, and some are not reported at all. It is difficult to assess the continued outcomes and safety without accurate reporting data."
Its called lawsuits, that's why the are not reporting it. Slashdot should post the same article over how many human surgeries that end in complications go unreported those types of surgeries are by far would exceed the lack of proper reporting on robotic complications, which is a huge huge problem of the "health care system/medical industry".
Those robotic surgeons operate 24 hours a day 7 days a week, they don't have time to write reports.
Its called lawsuits, that's why the are not reporting it. Slashdot should post the same article over how many human surgeries that end in complications go unreported those types of surgeries are by far would exceed the lack of proper reporting on robotic complications, which is a huge huge problem of the "health care system/medical industry".
Let's not try and minimize the complications from just surgeries. We're told half-truths with damn near every drug we try too. We all know that within a group of 100 people trying a new drug, there will be some percentage of that group where death is an acceptable side effect.
Then again, when they're (semi) truthful about a new drug, and spend the last 27 seconds of a commercial rattling off the side effect list, doubt I'm going to be any less worried about taking the new drug, wondering how many billions in profits they're trying to protect just long enough to avoid the major lawsuits and change the drug name.
Its a risk not to report it. If things are working as they should a manufacturer who does NOT report a problem and gets caught should loose his license to produce any medical grade works. For a single fault.
There are lives at stake. The least they should do is give info for accurate statistics.
Well, I might have a way, but it only works on a semi spherical planet in a vacuum.
It's even worse than that!
All the primary sources which would let us know about this are behind paywalls, so even when you post them on slashdot, nobody can read the freaking things, so it doesn't matter...
I was a big fan, but as a student of both philosophy and the history of science I had to ask how he justified performing the procedure *before* (until) he got the complication down to the level of the standard open incision. He was outraged (as were my classmates) and tersely stated that he had gotten consent (not knowing that I'd done a thesis on the inadequacies and inherent ludicracy of getting "informed consent", especially based on information from the surgeon who wishes to do the procedure).
It was a sincere question, one that I felt could not answer to my own satisfaction (his answer didn't help; he'd simply been looking to "the medical advance" and had never been trained in genuine ethics), but despite that, I feel that he had done the right thing, and that tens of millions have greatly benefited since.
Though not all would-be 'medical advances' end so salubriously, the sad fact is, we don't know any better way -- and I'd wager that we'll have workable fusion generators long before we have a better usable method for making medical advances. "First, do no harm" was a simplistic principle suited to the era before Christ when a doctor was as/more likely to do harm as/than good. (Note that the Hippocratic Oath forbids surgery outright)
We are now skilled enough that some of our advances seem "too good to deny to all comers" without full data -- but where are we to get that data, except by trial (and error). We are not yet advanced enough that MOST of our attempts at medical advance are so beneficial, nor are we advanced enough to have a much better alternative to "try it and see".
I called this back in July. The lawsuits for the Da Vinci Robot have been going on in my area for at least a year or more. I don't know about you, but I wouldn't want one of those things cutting on me until the Tech is reliable. They started using Da Vinci in the year 2000 and these issues are just now cropping up, so there is a huge backlog to sort through.
I needed mitral valve repair surgery, and I was a good candidate for robotic surgery: relatively young, good health (other than the valve), not obese (fat gets in the way). Instead of sawing my sternum and spreading my chest open, the surgeon (who has a lot of experience in both robotic and open heart surgery) was able to go in through my right side and leave a 3-inch scar and three puncture wounds. I was in the hospital Tuesday morning, and out Friday afternoon. I'm grateful to have had access to this technology. The benefits of robotic surgery compared to open heart surgery are clear (at least in my case).
But when a hospital has a large fixed cost to acquire technology, it is all too tempting to spread that cost out over a greater number of surgeries. The benefits are not nearly so clear in surgeries that don't require bone-breaking or bone-sawing. If someday I need gall bladder surgery, or if my spouse needs a hysterectomy, I would have a strong preference to avoid robotic surgery unless a skilled surgeon can make a compelling argument that the specifics of our case are a good fit for robotic assistance. (And believe me, I read as much of the medical literature as I could in making the decision: when one of the surgical steps is, basically, "shut down the heart," you want to know as much as you can. Open heart surgery for valve repair is a well-understood, well-practiced technique, but for me the decision to use the robot was about the reduced shock to the body, shorter recovery time, and reduced scarring.)
Has anybody here ever had users who were willing to file and capable of filing proper bug reports or trouble tickets?
investors and medicos on the bleeding edge of a new and they hope lucrative technology are doing to do everything they can to promote it, including silencing problems
There was no indication from the article that non-reporting or under-reporting was for the sake of "silencing problems". Obviously that's something that should be investigated, but don't jump to conclusions. If they are trying to silence it, they're doing a lousy job. There were 245 incidents properly reported, and 8 cases of under or non-reporting. That's 3% of the incidents having been "silenced".
I had cancer removed from my left kidney back in 2010. Two and half weeks later I was back to work. Normal surgery would have required almost 6 months to recover. I was lucky that I had the doctor from Duke medical who wrote the book on this type of surgery perform the operation.
I have to wonder how much of the underreporting is a result of pressure from the device manufacturer.
There were 245 incidents properly reported, and 8 cases of under or non-reporting. That's 3% of the incidents having been "silenced". Given the amount of money involved, I wouldn't completely rule out your concern. Nevertheless, if that's what they're trying to do, they're doing a lousy job. I'd recommend a Mafia consultant, as the NSA has shown itself to be inept.
Perhaps we could afford our medicine if we just paid for medicine without the added cost of the insurance and finance and legal lobby that have infiltrated our every transactional need.
Texas implemented tort "reform" for malpractice and it did nothing to control medical costs. Overhead and bureaucracy is another matter - it's well documented that our costs are several times higher than for countries with civilized and efficient systems, and it show in our costs. We're also the only developed country that relies on for-profit insurance companies for basic medical insurance. When Switzerland instituted universal health care about 20 years ago (about the last developed country to do so, aside from the US) they basically forced for-profit insurers out of the business, and I'd hardly call Switzerland an anti-business country.
What kind of training do surgeons undergo for using the da Vinci? That could be a big factor.
Da Vinci aside, what kind of training do surgeons undergo for regular laproscopic surgery? I would think/hope that people coming out of their residencies learned it from the get go, but what about surgeons who've been practicing for 10 or 20 years? I understand that regular laproscopic can be tough, if for no other reasons than that the tools operate backwards, and visibility can be an issue (those are some of the things the da Vinci is supposed to fix). Wish I could find the link, but it was reported that laproscopic worked better than traditional open, but only if the surgeon had good training and lots of experience.
There are eight known cases of under or non-reporting as evidenced by PACER and LexisNexis, i.e. cases that led to legal complaints. The number could be a little bit larger, although probably not by much.
I find it interesting that the Da Vinci name is still on the market; it carries a lot of negative connotations from early tests where it was used in fully-automated knee and hip surgery (although I think the current robot is different from the infamous one.) It tended to cause a great deal more damage than it fixed, as while it was perfectly good at fixing bone, there was no consideration whatsoever for soft tissue and, IIRC, it just cut its way in. It sounds like something out of Terminator when you hear it described in detail.
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I write these reports and analyze medical device complaints for a living. There is a legal responsibility to report any death or serious injury involving a medical device to the FDA within 30 days (5 days for very serious malfunctions) of the Become Aware date. That's the date that the reporter became aware there was an incident. This is filed on an Medical Device Report (Form 3500A). Both the users and manufacturers are responsible for reporting with the manufacturer having an obligation to investigate each reportable event and file an investigative conclusion (Follow up) if the investigation is not completed on the first report. The FDA audits medical device manufacturers on a regular basis (yearly, bi-annually, or for cause) and any missed reports found in the manufacturers records are automatic observations (483). A failure to respond to the observations can result in a Warning Letter. Further failure to respond leads to the Justice dept. getting involved and potential device seizure, manufacturing stoppage, and corporate shut down actions (Consent decree). An individual caught hiding info or being untruthful can face permanent black listing from ever working in a medical or medical device manufacturing profession for the rest of their life.
I am a surgeon. There is NO autonomous robotic system.
You're right, but we'll fix that, just as we're fixing it with aircraft now, and working towards it with cars. Real engineers find it abhorrent to let wetware control anything - it's never given us anything but trouble.
Doesn't mean they didn't try, and aren't continuing to try. Automated surgery sounds very appealing in principle.
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Are you a troll, or just that stupid?
You *certainly* don't want to live in any kind of society. People who sell things that break, badly, and don't admit it, can, if someone gets hurt enough, wind up in jail for fraud and criminal negligence.
And you... you're probably a libertarian, meaning you have the ethics and morals of a spoiled two-year-old.
mark
For bone surgeries the objective is a little easier; the operation can be performed with real-time tracking and registration under CT fluoroscopy (i.e. a continuous volumetric X-ray). My Google-fu is insufficient to find any relevant citations; the source was a lecturer in a medical imaging course.
Bio questions? Ask me to start a Q&A journal. Computer analogies available for most topics!
it merely moved the malpractice lawsuits to federal courts
That's your strawman. The cited costs of malpractice suits includes both state and federal cases. With some people it's so entrenched in their minds that "tort reform" is a an important way to reduce costs, that they refuse to accept the reality that it's not. "Including legal fees, insurance costs, and payouts, the cost of all US malpractice suits comes to less than one-half of 1 percent of health-care spending."
That's because tort reform was a JOKE.
In what jurisdiction was it a joke? How was it a joke? What should have been done?
I am a surgeon and I can say that the amount of a potential lawsuit is not the incentive to cover my ass. It's the act of being sued.
Why?
Especially when the legal system is rigged against the docs.
How so?
And my profession is ability to practice is at stake.
Really? There seem to be plenty of surgeons, and doctors in general, for an endangered profession. If you think there is a real shortage, consider pushing for an increase in the arbitrarily restricted number of residency slots.
P.S. I think most people would be willing to accept serious changes in the way malpractice is handled if doctors were more willing to police their own. Revoke the licenses of the truly incompetent doctors (and don't revoke them then issue a stay - which means it's supposedly going to be revoked but they can practice anyway). Institute truly systematic procedures for evaluating why a mistake happened (even if it doesn't rise to the level of malpractice), and actually act on those findings. That's the way really quality control is achieved in every other industry. Learn from operations research - everybody else has been doing it since it proved itself in WWII.