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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."
Those robotic surgeons operate 24 hours a day 7 days a week, they don't have time to write reports.
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 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?
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.