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Stoma Irrigation Pump

Posted by Douglas john
Hi World.

Can anybody tell me if there is a company in the USA that markets a Stoma Irrigation pump? In Europe we have Bbraun, but I dont belive that they sell this product in the USA. Bad move on their part as the market must be huge. Are there any other companies?

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Comments:
Nov 22, 2021 12:55 AM
veejay : Not helpful I know but they also aren't available here Australia either.....pity.???? V.J.
Nov 22, 2021 1:38 AM
Bill : Hello Douglas John. That's a real shame that this product is not available to you in the USA. I once wrote a rave review on the Braun irripump, in which I explained that whilst it was great there were things about it that did not suit my personal needs. As nobody else seemed to manufacture a similar product I made my own. In fact, I have made several versions of a pressurised irrigation system and they all worked perfectly well for my purposes. The cheapest and easiest to use were made from simple garden sprayers with the necessary stoma-irrigation devices attached. They were really easy to make and, as lonf as you abide by the common-sense guidelines for irrigation, then there should be no problem. If you want a more detailed account of my own endeavours, then let me know and I will try to elaborate. Best wishes Bill I hope this helps
Nov 23, 2021 4:50 AM
w30bob : Hi Doug, I did some digging, but without FDA approval no one can market such a device here in the States. So it's not Braun choosing not to market it here, it's our federal government prohibiting them from doing so. If I were you I'd call a good friend in the UK and have them mail you one.....as I wouldn't think they'd need a prescription to buy one. Otherwise, if you travel over there or have a good friend travelling over there......stick it in a box and ship it back to the States via UPS. I might be oversimplifying......but maybe not. When I was in Italy I did the same thing with some engine parts I couldn't get here. Just don't expect any warranty coverage if Braun finds out you're in the US. Looking at how the pump works I wouldn't think it would be that hard to make something similar, but I guess it depends on your craftsmanship abilities. I'll keep looking and ask friends if they know a way around the FDA......but don't get your hopes up. regards, bob
Dec 04, 2021 1:56 PM
Douglas john : Why on earth is it impossible to get a Stoma irrigation pump in America ? It's just plain stupid. Is there no medical engineering company capable of making a small fortune out of an obvious market ? It just doesn't make sense to me. D
Dec 05, 2021 7:23 PM
w30bob : Hi Douglas, I just checked the FDA's regulations for Ostomy Irrigators, and it's not obvious as to why such a device isn't allowed here State-side. You can take a look........it's in Title 21, Part 876, Subpart F, Section 876.5895...and this section was just recently updated. This makes me think the manufacturer of the pump probably hasn't tried to get FDA approval for the pump, not the FDA rejecting their application. Of course I could be wrong, but the blame for a lack of availability here in the States may be the manufacturer's fault, not the FDA's. I would contact Braun and see what the deal is. Here's my guess......I bet they looked into the idea of selling it here, but found our insurance companies wouldn't cover it, as the gravity system does the same job for a lot less money. Which means they'd only sell pumps to people who'd pay for them out of pocket. Which means the company can't inflate it's price to the insurance companies.....and wouldn't sell a whole lot of pumps here. Just a guess, but there is considerable cost in a non-US company importing medical products into the US. And I'd bet that's the same reason no US company has tried to market one either.........the insurance companies won't pay for it. Again, I could be totally off base with my guess......but if you find out anything please let us know. regards, bob