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posted by martyb on Thursday March 01 2018, @11:31AM   Printer-friendly
from the Oh-shit dept.

Colon and rectal surgeon Sanjiv Patankar allegedly washed and reused catheters that are inserted into patients' rectum during medical procedures. The instruments, which are used to examine patients with fecal incontinence, constipation, and other possible disorders, are supposed to be thrown away after a single use.

Patankar, who practiced in East Brunswick, [New Jersey] allegedly instructed medical assistants to wash the instruments in soapy water after use, soak them in bleach solutions, and then rinse before air-drying them. The doctor also reportedly ordered to continue using a catheter that has started to break down due to overbleaching.

In a hearing conducted Dec. 19, the state said that documented evidence appears to show that between Jan. 1 and Nov. 30, Patankar's office performed 82 procedures but only five catheters were used over that period.

Source: http://www.techtimes.com/articles/217801/20171230/doctor-accused-of-reusing-one-use-anal-catheters-on-multiple-patients.htm


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  • (Score: 5, Insightful) by c0lo on Thursday March 01 2018, @11:50AM (41 children)

    by c0lo (156) on Thursday March 01 2018, @11:50AM (#645722) Journal

    In a hearing conducted Dec. 19, the state said that documented evidence appears to show that between Jan. 1 and Nov. 30, Patankar's office performed 82 procedures but only five catheters were used over that period.

    I wonder - except the lost sale - is there a quantifiable risk to patients?
    If the FDA "do novo approvals track" or whatevs can show there's little-to-no-risk in the sterilization procedure, I say give that man a prize, he discovered a way to keep 77 plastic catheters out of the landfill.

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  • (Score: 0) by Anonymous Coward on Thursday March 01 2018, @12:31PM (1 child)

    by Anonymous Coward on Thursday March 01 2018, @12:31PM (#645729)

    There's the soap. And the bleach. Expertly rinsed and air-dried by professionals. Well, assistant professionals.
    No remnants, nor biological contaminants, can be present anymore, right?

    • (Score: 0) by Anonymous Coward on Thursday March 01 2018, @08:44PM

      by Anonymous Coward on Thursday March 01 2018, @08:44PM (#645967)

      Somehow, I get the idea you are more worried about "remnants" than about "biological contaminants".

  • (Score: 4, Insightful) by Bot on Thursday March 01 2018, @12:41PM (3 children)

    by Bot (3902) on Thursday March 01 2018, @12:41PM (#645734) Journal

    This is indeed a key point missing from TFS.
    The guy is clearly deserving a well directed punch so we can discover whether its front teeth are reusable, but it looks like the main sin is not giving to big pharma the dollars for the single use thingies.

    Anyway as a patient I would not subscribe to: Save the planet, less pollution, reusable catheters. Sex toys are not single use, so, we can do it!

    --
    Account abandoned.
    • (Score: 5, Funny) by Anonymous Coward on Thursday March 01 2018, @02:05PM (2 children)

      by Anonymous Coward on Thursday March 01 2018, @02:05PM (#645759)

      Sex toys are not single use

      WTF? She lied to me, said I could only do it once and then she had to get rid of me!

      • (Score: 0) by Anonymous Coward on Thursday March 01 2018, @05:52PM (1 child)

        by Anonymous Coward on Thursday March 01 2018, @05:52PM (#645872)

        WTF? She lied to me, said I could only do it once and then she had to get rid of me!

        "She"?? Were the lights off?

        • (Score: 2) by MostCynical on Thursday March 01 2018, @09:52PM

          by MostCynical (2589) on Thursday March 01 2018, @09:52PM (#646025) Journal

          Was her name Lola?

          --
          "I guess once you start doubting, there's no end to it." -Batou, Ghost in the Shell: Stand Alone Complex
  • (Score: 2) by DavePolaschek on Thursday March 01 2018, @01:35PM (5 children)

    by DavePolaschek (6129) on Thursday March 01 2018, @01:35PM (#645745) Homepage Journal

    I wonder - except the lost sale - is there a quantifiable risk to patients?

    You mean beyond the "Ewwwwwww!" factor?

    • (Score: 2) by c0lo on Thursday March 01 2018, @01:45PM (3 children)

      by c0lo (156) on Thursday March 01 2018, @01:45PM (#645751) Journal

      See? This must have unmasked me as a non-right-wing person [soylentnews.org], right? 'Cause I didn't show any "ewww!" factor in my comment.

      Based on this, I wonder how the right-wings use their sex toys? Single use only?
      Who should I ask, I wonder who should I ask?

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0
      • (Score: 2) by vux984 on Thursday March 01 2018, @03:59PM

        by vux984 (5045) on Thursday March 01 2018, @03:59PM (#645817)

        Not 'single use', but I'd expect, like underwear, that its mostly 'single user'.

      • (Score: 0) by Anonymous Coward on Thursday March 01 2018, @06:15PM (1 child)

        by Anonymous Coward on Thursday March 01 2018, @06:15PM (#645885)

        Nope, nope, nope.

        Connect the compatible parts. That's it. The digestive tract is not involved. Nothing non-human is involved, and there are exactly 2 humans involved.

        Humans get matched up in pairs, without any sort of swapping or trading or switching.

        • (Score: 2) by realDonaldTrump on Saturday March 03 2018, @11:27AM

          by realDonaldTrump (6614) on Saturday March 03 2018, @11:27AM (#647000) Homepage Journal

          You must be a TERRIFIC student. Because that's what they taught us in school. Maybe you learned from the same textbook, Health and How to Get It. And the way they taught us works tremendously, I made four beautiful children that way. But I've been married 3 times and I'm a GREAT negotiator. So I ordered a 3-headed dildo. The kind that has the heads pointing in 3 directions, not the kind with the 3 heads in a row (very important). And I'm going to invite Ivana and Marla over..........

    • (Score: 0) by Anonymous Coward on Friday March 02 2018, @05:41AM

      by Anonymous Coward on Friday March 02 2018, @05:41AM (#646222)

      What do you expect.. Indian doctor. Its in their DNA. Guptas stripped South Africa's assets (R100 billion or more); Indians are at the top of Google, Microsoft, etc - USAians will soon discover themselves slaves (and without money) in their own land.

  • (Score: 3, Interesting) by JoeMerchant on Thursday March 01 2018, @01:56PM (17 children)

    by JoeMerchant (3937) on Thursday March 01 2018, @01:56PM (#645757)

    Reuse of single use medical devices is very common practice.

    The problem with it is: you've got M.D.s who know f-all about device safety and even sterilization making judgement calls about how, and how long they can reuse a device.

    Sterilize a device too aggressively and you degrade its function (like the overbleached catheters mentioned in the summary), don't do it aggressively enough and you get cross-contamination.

    All in all, if I'm going to be cross-contaminated, I'd rather it happen in the lower bowel instead of the bloodstream or sub-cutaneous tissue. Of course, if the cross-contamination is coming from someone with bowel problems, that's less than ideal, but Sanjiv's homebrew bleach solution probably knocked back the levels of live cultures to something more or less trivial for an existing bowel flora to overwhelm. But, I'd bet his methods were far from the level of "sterility" required for official labeling of medical devices as such.

    I attribute some of this situation to the "M.D. god complex" that we push them into. Their time is so precious, their judgement so valuable, they literally do get god complexes that make them blind to their limitations.

    --
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    • (Score: 2) by Lester on Thursday March 01 2018, @03:34PM (8 children)

      by Lester (6231) on Thursday March 01 2018, @03:34PM (#645805) Journal

      Sterilize a device too aggressively and you degrade its function

      They only must have been designed to be sterilized many times. Many medical devices, like scalpels, scissors etc, are regularly sterilized and reused many times.

      For years syringes and needles were reusable, they were sterilized and reused. That changed when HIV appeared. Until then, except cotton, bandage etc, most medical devices were reusable. Disposable devices have several advantages, you don't waste time sterilizing, you don't need a big department of sterilization so you reduce costs, and you reduce cross-contamination risk to 0%. On the other hand, you have to buy many times and there is more overspend. So, disposable elements much be cheap to balance the cost of sterilizing it.

      Nevertheless, there is a trend, each time disposable elements a more expensive. I suppose that it is a combination of consumerism society, convenience and health staff laziness.

      • (Score: 3, Informative) by JoeMerchant on Thursday March 01 2018, @04:14PM (5 children)

        by JoeMerchant (3937) on Thursday March 01 2018, @04:14PM (#645825)

        Personally, if I'm having a catheter inserted in my rectum, I'd rather it not be constructed of the same types of reusable medical materials as are used to make scalpels, needles and (reusable glass) syringes.

        The soft, flexible medical materials do not tend to hold up well to repeat sterilizations, whether by heat, EtO, or soapy water and bleach (which is more of a cleaning solution than a certifiable sterilization process.)

        The disposable/reusable issue in the med device industry is a weird thing that kind of cycles like fashion. LOW COST LOW COST LOW COST they chant, so you give them a low cost disposable, 1/10th the price of a sterilizable reusable one, but that's not good enough, they should be able to sterilize and reuse the device 100 times, so then they want the durable version. There's a practical point at which the cost of sterilization (staff time, equipment maintenance, etc.) exceeds the cost of the device (and this point varies widely around the world due to labor costs), but... there's also a whole other layer of absurdity piled on when a relatively simple surgery bills out at $15K, so why wouldn't you use a $500 disposable device during that surgery if it increases the chances of a good outcome?

        --
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        • (Score: 2) by frojack on Thursday March 01 2018, @06:41PM (4 children)

          by frojack (1554) Subscriber Badge on Thursday March 01 2018, @06:41PM (#645897) Journal

          I'm amazed you have such faith in the factory packaged plastic device ASSUMED to be sterile out of the package. I don't.

          Its a numbers game. Of the millions made, probably only 10 percent are contaminated at the factory, and probably the patient's immune system is sufficient to handle 70 percent of those cases, and the anti-viral/biotics will (probably) handle most of the rest.

          --
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          • (Score: 0) by Anonymous Coward on Thursday March 01 2018, @07:45PM

            by Anonymous Coward on Thursday March 01 2018, @07:45PM (#645939)

            There is a difference between bacteria found on a surface of an air exposed surface and bacteria out of someone's leaky ass. C. diff. is not that likely to live in one of these places.

            https://en.wikipedia.org/wiki/Clostridium_difficile_infection [wikipedia.org]

          • (Score: 2) by JoeMerchant on Thursday March 01 2018, @08:08PM (1 child)

            by JoeMerchant (3937) on Thursday March 01 2018, @08:08PM (#645946)

            Take a tour of a med-device sterilization facility sometime, then tell me what your 10% non-sterile estimate turns to. I'm sure there are some places where it would run higher, but the ones I've worked at in the U.S. probably run closer to 0.001% non-sterile at time of unpackaging, and those that are non-sterile are mostly sterile.

            The latest trend in sterilization is fast-cycle EtO - we just decreased our cycle time to 12 hours. EtO is nasty, explosive stuff - if our EtO facility ignited, it would leave a big crater, and the "windows blown out" blast radius would be something like 500 meters. They put up with this little challenge because it's really really good at killing bacteria and viruses without degrading the finished products being sterilized. It's not your hospitals' typical autoclave.

            --
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            • (Score: 0) by Anonymous Coward on Thursday March 01 2018, @10:39PM

              by Anonymous Coward on Thursday March 01 2018, @10:39PM (#646055)

              what a cool looking simple molecule

          • (Score: -1, Flamebait) by Anonymous Coward on Thursday March 01 2018, @08:51PM

            by Anonymous Coward on Thursday March 01 2018, @08:51PM (#645973)

            I'm amazed you have such faith in the factory packaged plastic device ASSUMED to be sterile out of the package. I don't.

            This, right here, is what makes frojack the conservative he is! Fear of disease, aversion to bad smells, invincible ignorance and a foundational lack of trust in his fellow human beings. I don't know how someone could live like that, at least not without a large hoard of single-user anal catheters that he had sterilized himself.

      • (Score: 2) by HiThere on Thursday March 01 2018, @07:38PM

        by HiThere (866) on Thursday March 01 2018, @07:38PM (#645932) Journal

        But if you remember, before reuse the devices were supposed to not only be washed, but autoclaved. Boiling wasn't considered hot enough.

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      • (Score: 2) by requerdanos on Thursday March 01 2018, @10:03PM

        by requerdanos (5997) Subscriber Badge on Thursday March 01 2018, @10:03PM (#646033) Journal

        I understand that it's a balance, and not only that, but a balance designed to reduce not only costs but injuries and deaths. But playing devil's advocate for a moment...

        waste time sterilizing

        Isn't this time, and more, now spent manufacturing hundreds of thousands of medical devices to replace a single device that previously would have been used repeatedly throughout a long service life, and also spent managing and maintaining ever-larger landfills to contain an ever-larger percentage of waste now deemed "disposable" instead of "durable"?

        you don't need a big department of sterilization so you reduce costs

        You reduce costs by buying an item 5,000 times instead of once?

        you have to buy many times [so] disposable elements much be cheap to balance the cost of sterilizing

        I submit that each iteration of each device would have been made more and more cheaply, anyway, regardless of whether it was intended for multiple or single use.

        you reduce cross-contamination risk to 0%

        There remain a staggering number of vectors for cross-contamination (same person touches two devices, two devices touch same surface, etc.) even after you start printing "Use This Thing Only Once" on the packaging. For a case in point, consider the story you're commenting on.

    • (Score: 2) by requerdanos on Thursday March 01 2018, @05:00PM (7 children)

      by requerdanos (5997) Subscriber Badge on Thursday March 01 2018, @05:00PM (#645845) Journal

      The problem with it is: you've got M.D.s who know f-all about device safety and even sterilization making judgement calls about how, and how long they can reuse a device.

      This is complicated by another problem somewhere. I don't know whether it's strange regulation, or merely manufacturers to blame, but last time I had surgery done, the site of the surgical procedure was marked with a sharpie marker covered in warning labels about how Federal Law Prohibits Re-Use and that the user must Discard After Use.

      I pulled it out of the trash and used it to label burned CDs and DVDs until it ran out (years later).

      Seems to have been a thing about how the manufacturer can't guarantee that it's sterile after the first use--I get that--but that statement applies to nearly everything in the hospital that's not disposable. We don't throw the hospital away and rebuild it between patients because that would be stupid. This is sort of like that.

      Because of this non-sustainable disposables-mentality, there is not a culture of proper, safe sterilization being encouraged.

      • (Score: 2) by HiThere on Thursday March 01 2018, @07:44PM (6 children)

        by HiThere (866) on Thursday March 01 2018, @07:44PM (#645936) Journal

        Partially yes, but also partially no. Bacteria are evolving to evade more and more of our sanitary procedures. Single use sharpies are a bit over the top, but using them only on one patient is quite a reasonable procedure. And we're approaching the point were the hospitals may not be single use, but the room furnishing are. This is usually excessive caution, but not always. Many iatrogenic diseases are spread by insufficient sanitary procedures, and some have been traced to bacteria that lived on the curtains of the room between patients.

        Caution: I am not associated with any hospital, so I can't tell you what current procedures are. But some bacteria are evolving to become immune to the alcohol hand sanitizers, so expect an increase in the use of plastic gloves.

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        • (Score: 3, Interesting) by JoeMerchant on Thursday March 01 2018, @08:02PM (4 children)

          by JoeMerchant (3937) on Thursday March 01 2018, @08:02PM (#645944)

          It really does get down to the question of: you're charging $15,000 for this procedure, do you want to save $5 on a reusable sharpie when that puts a 0.1% chance of infection and bad outcome which might lead to $100K+ in malpractice settlement? Far better to charge $15,100 for the procedure and use the $5 disposable sharpie.

          --
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          • (Score: 2) by requerdanos on Thursday March 01 2018, @08:15PM (3 children)

            by requerdanos (5997) Subscriber Badge on Thursday March 01 2018, @08:15PM (#645950) Journal

            the $5 disposable sharpie.

            Well, they're more like $1.00 - $1.50 [bettymills.com] in lots of 50, manufacturer guaranteed sterile, bundled with a free sterile ruler and a pack of blank labels.

            So maybe this is a bad example.

            • (Score: 2) by JoeMerchant on Thursday March 01 2018, @09:10PM (2 children)

              by JoeMerchant (3937) on Thursday March 01 2018, @09:10PM (#645991)

              they're more like $1.00 - $1.50

              did you find an itemized line item for it on your surgery bill? They have started doing something sensible like charging $100 for miscellaneous stuff which catches things like the sharpie, but if it's itemized, I doubt it's less than $5.

              --
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              • (Score: 2) by requerdanos on Thursday March 01 2018, @09:27PM (1 child)

                by requerdanos (5997) Subscriber Badge on Thursday March 01 2018, @09:27PM (#646006) Journal

                itemized line item for it on your surgery bill?

                No, that's just what it would cost the hospital if they bought from the link above.

                • (Score: 2) by JoeMerchant on Thursday March 01 2018, @09:33PM

                  by JoeMerchant (3937) on Thursday March 01 2018, @09:33PM (#646011)

                  that's just what it would cost the hospital if they bought from the link above.

                  That's the purchase price, then there's the general accounting overhead, cost of storage, cost to ensure safe delivery to the patient, cost of damaged goods, etc. etc. etc. - those are the wonderful accounting methods that come up with a price of $10 for a Tylenol capsule delivered to you postoperatively.

                  --
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        • (Score: 0) by Anonymous Coward on Friday March 02 2018, @12:17AM

          by Anonymous Coward on Friday March 02 2018, @12:17AM (#646111)

          Caution: I am not associated with any hospital, so I can't tell you what current procedures are. But some bacteria are evolving to become immune to the alcohol hand sanitizers, so expect an increase in the use of plastic gloves.

          You sure about this? I didn't think alcohol was something bacteria could become immune to.

          A google search only leads to a recent New Scientist news article on this, but nothing else of note, and the New Scientist article is paywalled, so I can't see what it says.

  • (Score: 5, Informative) by AthanasiusKircher on Thursday March 01 2018, @02:12PM (3 children)

    by AthanasiusKircher (5291) on Thursday March 01 2018, @02:12PM (#645763) Journal

    A couple potential issues, even if we buy a "saving the environment" motivation.

    (1) Sterilization procedures require thorough testing in medicine. A quick search shows a lot of articles in medical journals on catheter sterilization, including more expensive rectal devices that may need reuse. Did the doctor follow an empirically verified sterilization procedure?

    (2) Apparently he did this with catheters specifically labeled as "single-use" with "DO NOT RE-USE" on the packaging. Medical devices intended for re-use are generally built to be more sturdy and to hold up to things like repeated sterilization procedures. Perhaps more importantly, a single-use device may be made in such a way that it cannot be sterilized effectively using normal sterilization procedures (e.g., made out of a more porous plastic that can trap bacteria in places that are difficult to sterilize, etc.).

    Bottom line is that there are procedures and devices that are tested to ensure safety when they are reused. This doctor was at a minimum using devices not intended to be used this way, which could have risks.

    I don't know enough about the situation to know how risky it might be though...

    • (Score: 1, Redundant) by c0lo on Thursday March 01 2018, @02:25PM

      by c0lo (156) on Thursday March 01 2018, @02:25PM (#645766) Journal

      Did the doctor follow an empirically verified sterilization procedure?

      As TFA says he wasn't charged of any damage to patients even after the Attorney General office was involved. I musy assume that he himself empirically verified the sterilization procedure and followed it, no? (grin)

      This doctor was at a minimum using devices not intended to be used this way...

      TFA says that's the maximum as well:

      "Attorney General Christopher S. Porrino and the Division of Consumer Affairs today announced that a Committee of the State Board of Medical Examiners ("the Committee") has temporarily suspended the license of a Middlesex surgeon amid allegations he jeopardized his patients' health and safety by reusing single-use catheters on multiple patients during anorectal diagnostic testing.," the office of the Attorney General said in a statement.

      --
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    • (Score: 4, Informative) by mhajicek on Thursday March 01 2018, @03:14PM

      by mhajicek (51) Subscriber Badge on Thursday March 01 2018, @03:14PM (#645791)

      I make medical devices (machinist and designer for medical device company), and you are correct. When possible devices are multi use. When use degrades a device too much for it to be safely and reliably reused it must be single use.

      --
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    • (Score: 3, Interesting) by JoeMerchant on Thursday March 01 2018, @04:21PM

      by JoeMerchant (3937) on Thursday March 01 2018, @04:21PM (#645831)

      Bottom line: the doctor used his M.D. judgement and made a call which resulted in an outrageous story headline - regardless of his medical acumen, he obviously is out of touch with what society will (try to) do to him after the story gets around, or maybe this is his way of seeking his 15 minutes of fame - who knows.

      M.D.s use devices off-label all the time, but re-use of labeled single-use devices is one that most hospital legal departments will frown upon, heavily. The only thing that Sanjiv could possibly have been attempting to do with this off-label re-use is to save a little money - now, if he went full disclosure with his patients and gave them two-tier pricing options... maybe, just maybe that might fly, but I've never met an M.D. that's this forthcoming with patients about the choices that the M.D. makes in their care.

      --
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  • (Score: 3, Interesting) by frojack on Thursday March 01 2018, @06:31PM

    by frojack (1554) Subscriber Badge on Thursday March 01 2018, @06:31PM (#645892) Journal

    is there a quantifiable risk to patients?

    My question exactly.

    It would seem that he followed a completely acceptable medical sterilization protocol.

    http://www.ast.org/uploadedFiles/Main_Site/Content/About_Us/Standard_Decontamination_%20Surgical_Instruments_.pdf [ast.org]
    https://www.henryschein.com/us-en/OBGYN/ResourceCenter/InstrumentReprocessSixSteps.aspx [henryschein.com]

    allegedly instructed medical assistants to wash the instruments in soapy water after use, soak them in bleach solutions, and then rinse before air-drying them.

    Since they were not steel, autoclave was probably not an option.

    Now you might suggest that the factory packaging is guaranteed to be more sterile. However, i suspect a tour of the plant would be rather alarming, and you would see that the "sterile" packaging arrives on rolls, are run through a machine with an ancient UV light as the only final sterilization step before packaging.

    --
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  • (Score: 2) by EvilSS on Thursday March 01 2018, @07:14PM

    by EvilSS (1456) Subscriber Badge on Thursday March 01 2018, @07:14PM (#645919)
    The material they are made from is probably not designed to be sanitized, so it's quite possible that it's harboring microbes even after their cleaning process. Some pathogenic microbes found in the gut are pretty resilient so yea, there is a risk.
  • (Score: 2) by krishnoid on Thursday March 01 2018, @08:26PM

    by krishnoid (1156) on Thursday March 01 2018, @08:26PM (#645959)

    Hey, at least he bothered to sterilize them [youtube.com].

  • (Score: 2) by All Your Lawn Are Belong To Us on Friday March 02 2018, @02:07PM (3 children)

    by All Your Lawn Are Belong To Us (6553) on Friday March 02 2018, @02:07PM (#646358) Journal

    Yes. There is a risk. Aside from the question of what concentration bleach and was it enough to kill endospores, if the catheters were not certified for sterilization and did begin to deterioriate as the study suggests, you could have micropockets form in the material which would provide a safe harbor for endospores that never get the bleach contact. Think cutting boards [ncsu.edu], only the cutting was done by chemicals.

    That's why reusable medical grade tools that are invasive must (very generally) be autoclavable. Or have gone through testing which proves that a given disinfecting procedure will kill pathogens. Not just trust "wash it up and it'll be OK because I'm a Doctor and I say so."

    If this were a zombie apocalypse, would you be able to follow procedures like that in order to keep your tools available for another patient? OK, fine. Are we in a zombie apocalypse? No? Then what you have here is a physician who cut corners on safety to put money in his pocket. Delicense him, or give him the hardest reprimand possible and let the insurances desert him.

    --
    This sig for rent.
    • (Score: 2) by c0lo on Friday March 02 2018, @02:24PM (2 children)

      by c0lo (156) on Friday March 02 2018, @02:24PM (#646365) Journal

      Yes. There is a risk.

      Let me ask again: " is there a quantifiable risk to patients?"
      Should I bold it next time?

      --
      https://www.youtube.com/watch?v=aoFiw2jMy-0