The title is sure to draw a snicker from some readers, but the purpose of this field-expedient treatment for postpartum hemorrhage is deadly serious, and a true medical hack that has the potential to save the lives of new mothers.
Postpartum hemorrhage is the leading cause of death during pregnancy, claiming about 86,000 women every year. While it can occur up to six weeks after giving birth, PPH is most serious immediately after delivery and can require aggressive treatment to prevent hypovolemic shock and eventual death. A fully equipped obstetrical suite will have access to an array of medications and devices to staunch the flow, including a uterine balloon tamponade (UBT) kit. But at $400 a kit, these devices are hard to come by in the developing world.
Not to be dissuaded, midwife [Anne Mulinge] from Nairobi, Kenya created a simple, cheap substitute using common items. A common urinary catheter is covered with an ordinary condom, the end of which is secured around the catheter with twine. Once inserted into the woman’s uterus, the condom is filled with saline solution through the catheter, expanding the condom and applying direct pressure to the bleeding uterine walls. The pressure allows the mother’s clotting mechanism to catch up with the decreased blood flow.
So far, [Anne] claims the device has saved three new mothers, and other midwives are being trained in the technique. Here’s hoping that more lives are saved with this simple hack, and perhaps with this more complex one designed to get blood to remote clinics as fast as possible.
Thanks to [LP Bing] for the tip.
” A fully equipped obstetrical suite will have access to an array of medications and devices to staunch the flow, including a uterine balloon tamponade (UBT) kit. But at $400 a kit, these devices are hard to come by in the developing world.”
I imagine that’s more for the “medical grade, cover our ass, seal of approval” than anything to do with material costs.
It could be that hospitals have precision equipment regulating the pressure in the balloon, which would drive up the cost. I imagine it’s more effective at some very particular pressure.
I would imagine that a particular pressure is almost vanishingly less important than any pressure at all. This is just putting pressure on a wound, with the catch that the wound is internal, rather than external like I was trained for in first aid.
Pressure could be important. Imagine that the balloon is filled via a saline bag suspended at normal height above the patient; the pressure would not reach a dangerous level. But, after the balloon is filled, a leak is noticed and an untrained individual reaches for a syringe to refill it. Here is where medical professionals worry.
Hydraulic pressure.
I learned, when I had a PICC line installed, that I was never to use a syringe smaller than 10ml. Being sick, and not thinking like an engineer, it took me a while to realize the problem.
Average squeeze strength of someone 20 to 50 could be as high as 70lbs. If moderate force is applied to a large, 100ml, syringe that is over an inch in diameter then just a moderate squeeze of 40lbs translate to almost 350 kp or, since blood pressure is measured in mm of mercury, over 2600mmHg. On a tiny, 1 ml syringe, that is over 8.5 megapascals. Even light pressure of 4lbs on the tiny syringes would be over 800 kp. That much pressure can blow out IV catheters, and even a condom isn’t designed to stop that. And just like any other hydraulic problem, that small area generating the high pressure puts that much pressure across some woman’s entire abdomen.
So I could see where “medical devices” would need some fail-safe.
Hydraulics 101.
Is it a matter of risk vs. reward though? E.g. the less common risk of a blow out causing enormous pressure on the abdomen vs. maybe more certain to die from hemorrhage? I may want to take that risk. From the article, “So far, [Anne] claims the device has saved three new mothers…”
I wasn’t replying to the risk/reward factor; I was addressing the need for “medical surgical grade” equipment to address the possible mistakes and fail safe. In places where that isn’t an option, anything is better than the alternative.
Can confirm, medical devices are generally well engineered with quality control, particularly mechanical ones. That said, the costs of some items (to the patient or insurance company) are at times not even remotely in line with the actual aggregate costs plus a reasonable margin.
You also want built in safeties, such as actual hard limits on possible exerted pressures in this case in order to prevent further injury. Inflating this with hand pressure seems to do a fairly good job of preventing automated injury since there is no automated process. Plus, there is limited feedback to ensure the condom did not accidentally rupture.
I would be a little bit concerned about the condom rupturing due to it being a thinner and less ideal material than equivalent medical bladders and I suppose latex allergies are also marginally relevant though probably pretty low on the list of actual concerns given the expected usage environment.
In the medical device industry, medical device companies have anywhere from a 30% to 90% margins. That means for a $100 device, it costs $70 to $10 respectively to make. Typically your very common devices that are made in the millions and have been around have the lower 30% margins while the latest and greatest devices with much, much lower volumes have the higher margins.
Now what that cost does not include is the massive costs required to get these devices approved by the FDA and other world regulatory bodies. It does not include the cost of designing and development of the device. It does not include the cost is for liability insurance All these costs and others are paid for over time by the margin.
Its great what these midwives have done, but it would never be allowed in the US. If a doctor did this and the mother died, he would be sued for malpractice because the doctor did not follow the standard of care.
You forgot to mention the role of patents and how they can dramatically change the cost dynamic. Or the ways in which different hospitals can pay dramatically different prices for the exact same item at the exact same quantities due to a myriad of agreements.
Your quoted 30% to 90% margin goes right out the window when that happens. Especially when you add on multiple other parties in the payment process.
http://www.nytimes.com/2013/08/27/health/exploring-salines-secret-costs.html
“An IV bag to replenish lost fluids or to receive medication is one of the least expensive. The average manufacturer’s price, according to government data, has fluctuated in recent years from 44 cents to $1.”
“Yet there is nothing either cheap or simple about its ultimate cost, as I learned when I tried to trace the commercial path of IV bags from the factory to the veins of more than 100 patients struck by a May 2012 outbreak of food poisoning in upstate New York.”
“Some of the patients’ bills would later include markups of 100 to 200 times the manufacturer’s price, not counting separate charges for “IV administration.” And on other bills, a bundled charge for “IV therapy” was almost 1,000 times the official cost of the solution.”
She was billed “$6,844, including $546 for six liters of saline that cost the hospital $5.16.” Which cost $0.44 to $1.00 to produce.
Sounds familiar. A nurse was telling us the foam mattresses in the hospital cost $4k each.
cheap to make, but requires a ton of equipment and processes to guarantee it is sterile, traceable etc. etc.
even taking that into account their markup is still in the dozens of times the production cost, i wouldn’t be surprised to see a markup of 50-100 times the production cost in American healthcare.
As much as anything it’s the economics of lifesaving. If your uterus is hemorrhaging, you *have* to treat it. If it’s cheap, you’re not going to treat it twice just for funsies. In other words, lifesaving treatments have inherently inelastic demand.
Finally a true hack article.
And here I was searching for the first “Not a hack comment”.
Oh, this is /definitely/ a hack — and an awesome one at that.
Anything that saves lives is a good thing, in my book.
But stopping people from watching ‘The Ring’ video and not picking up the phone saves lives, is a good thing, but definitely not a hack. …unless you have a 27 point facial profile of Samara for OpenCV and can program a camera equipped bot to detect the watching before it goes to far and Rube-Goldberg an emergency shutoff of whatever device on which it was being watched. Then, with troll approval, it is a hack…
Yeah there aren’t too many other hacks on this site that you can say were macgyvered in the field and saved 3 lives already, this is awesome
Damn straight, and a life saving one, now if someone would come with a simple UBT that could be made for a couple of bucks and supplied to the third world, I mean this is great but I don’t think condoms are really built to do this.
The easiest part is coming up with the device. The hard part would be distributing it, education, and being fully vulnerable to taking the heat (financially) if something went wrong.
Good balloon would be much less likely to fail.
But also much less likely to be sterile.
The uterus is not sterile and having a sterile balloon would be a waste especially as it has to traverse through the vagina to be deployed. It just has to be relatively clean.
I think the idea is that you want to prevent adding additional exogenous agents into the uterus that would act as paths for infection. Adding in routes for infection is the whole reason why you would this or any inserted medical device to be sterile rather than merely relatively clean.
Having something sterilized and maintaining that sterility makes things many orders of magnitude higher in cost.
Insertion of a foreign object into a cavity that has communication to the outside world does not increase the chance for infection (as in providing for a path for infection) as the amount of time that foreign body is in place will be short enough to not allow for pathogenic bacteria to take hold and overcome the normal flora already present. Examples would be dentures, contact lens, and tampons. There will be bacteria on those items as soon as the user interacts with them by taking them out of the packet so they will not be sterile at all during application. However, the user is encouraged to remove any visible soiling from their hands (such as washing) prior to manipulation of such objects and therefore they be relatively clean. Even the gloves put on during routine examinations are not sterile (they come in a cardboard box and remain exposed to room air for days to weeks after opening). You can put such gloves on and start handling instrumentation such as a vaginal speculum and thus break its sterility yet it’s fine to do so because the bacteria introduced to the vaginal cavity is inconsequential.
If you are inserting a foreign object into the body that will remain for a moderate length of time (catheter, central line, shunt, device, etc) then yes sterility will absolutely be needed but for instances where the object will remain in for less than a day then just being clean is good enough.
Note that this applies to general flora commonly found on the skin. If you introduce highly pathogenic bacteria then that is an entirely different matter and even then a thorough washing in soap/water is sufficient.
I also just want to add that this by no means applies to the thought of not keeping instrumentation and temporary devices sterile during transportation and storage. To evaluate whether or not something needs to be kept sterile or can be just clean during such times is more of a case by case basis. One has to determine if the environment that the object is kept in is conducive to bacterial proliferation or not. If it is then having it sterile is the best choice but if the environment is not conducive then it being clean is good enough. Example is a contact lens vs a box of gloves. A contact lens is stored in a liquid medium which can provide for a nice environment for bacterial proliferation versus a box of gloves where the environment is more or less dry and thus not conducive for bacterial proliferation.
A wrapped condom and urine catheter would be sterile as they’re both meant to be inserted into body openings. The twine could be given a soak in alcohol before tying it on.
IIRC it was in the 1980’s when an IUD caused deaths of several women by infection due to the removal line being a multi-strand instead of monofilament. Extending through the cervix it provided a path for bacteria to enter the uterus then up the Fallopian tubes to the abdominal cavity. Once in there the bacteria went wild outside of the blood vessels, where it wasn’t accessible to white cells from the immune system. Another IIRC, monofilament was specified in the design but somewhere between there and production, someone changed it. The design was FDA approved, what was actually produced would not have passed approval.
That infection route is what killed large numbers of women shortly after childbirth, before doctors washed their hands prior to and several times during assisting with birth.
“IIRC it was in the 1980’s when an IUD caused deaths of several women by infection due to the removal line being a multi-strand instead of monofilament.”
That would be the Dalkon shield and it actually occurred in the 70s. Hundreds of thousands of women claimed injuries as a result of the device and there were large lawsuits against the company which eventually drove them bankrupt. It was a pretty big deal.
A condom is probably the strongest balloon I’ve ever seen. :)
There’s probably a YouTube video showing them being tested.
Seems like it might be better to use a gravity feed with this instead of a syringe. That would be a way of delivering a predictable pressure.
Except there are three issues with that. One, you are limited by the upper threshold of pressure available, which would likely quickly exceed reasonable heights that you would have to use. Secondly, you lose all feedback unless you had a flowmeter as to if flow was happening and you would also lose all feedback as to how much resistance there was pushing against. Fortunately, the upper threshold of pressure is at least limited by the height of the water above the patient.
Using Imperial units, to determine pounds per square inch at the bottom of a column of water, one needs to multiply the feet of height of the column (head) times 0.434 to get PSI. So assuming a typical height person was holding a bag of water above somebody who was laying on the ground and holding it as high as you could, you would achieve a maximum pressure of somewhere around 3.5 PSI using gravity alone. If they were on a table, you would be looking at perhaps 1.736 PSI or so maximum.
That is a really thorough reply. Thank you.
Gravity feed “enema” filling, height is very controllable.
brilliant!!!!!!!!!!!!!
I’ve been in the delivery room and seen this happen in real time, it’s terrifying for everyone even in a first rate hospital. She is so glad she changed her mind about having a home birth, she would have died. I can’t imagine the horror of losing someone so quickly with no options at all. This is beautiful work. Someone needs to fund the crap out of this.
My mum nearly died from this when she had me, they pumped 8 points of blood in her before the bleeding stopped. It was coming out as fast as it went in. She was in a different hospital too me for a week after being transferred from the small cottage hospital I was born in. This was in 1969 in the UK. I can see how in developing countries that this can be really bad.
Very good hack and is making the world news. Seen it on the BBC. Really cool. Well done Anne Mulinge. :)
KUDOS to Anne Mulinge for performance in service to humanity using the truest form of hacking.
This isn’t a new “hack”, not by a long shot.
In medicine, we love our inflatable things. From inflatable gloves to make into chickens for the kids, to coronary stent erectors, balloons are a cool tool. Some of them require serious precision (Embolization of a vessel is one that jumps immediately to mind).
However, a huge number of places have to build these things from scratch (Ok, I’ll be honest… I don’t think anyone is trying to embolize a coronary artery using a condom over a central line kit catheter).
It’s interesting that folks immediately went to the engineering side of the pressure problem. I’m going to tell you what happens in the field: We build the system (quickly), do a pre-inflate to make inserting and positioning the apparatus easier, then inflate to “fullness”. At this point the bleeding has not stopped, but the inflating IV bag is changed and then elevated until the bleeding ceases.
Could we over press the system? Unlikely. If we remove any pressure, then the bleeding resumes and the patient dies (post-partum hemorrhage is pretty bad if it goes unchecked). We do have the option of putting a blood pressure cuff around the bag (which would give us a decent measure of the pressure on the bag), but why tie up the bag?
IF the pressure to control bleeding exceeds the capillary circulation pressure, then you could see some tissue die off, but again, if you drop the pressure on the bag then the patient is going to bleed out and die.
Now, if you’re smart, you’re checking that bag routinely through the shift (I’m not going to lie and say the staff is checking hourly…). Additionally, the bag can be used as an indicator. If you mark the fluid level, and see the fluid level is changing, that is an indicator of a leak or increased pressure (not a great indicator, because the patient changing position can change the fluid level).
We went to the engineering side because, at least in my case, my medical knowledge does not include any certifications.
All said, you probably could not over pressure the bag with suspended saline bags. It would take 10 feet to get 4PSI (200mmHg).
This was actually devised, tested and used to save thousands of lives over the past 15 years by Sayeba Akhter, FCPS, an OB/GYN from Bangladesh.
Here’s the link to her white paper that she published back in 2003: http://www.medscape.com/viewarticle/459894_1
She addressed almost every concerns that one can have about the procedure.
Aren’t there existing lower thoracic blood flow inhibitor drugs that act quickly, and are robust to deploy/store in ampules even at environmental-range temperatures and with relatively long shelf life that have been around for decades? Or maybe high relative drug costs in developing countries and/or side affects prevent such drugs from being deployed as standard “kit” for field use.