Look, I'm not exactly the Cheer Squad for the FDA. I know way too many "conflict of interest" employees, and they have a tendency to ban anything they can't regulate, even when it's way safer than the solutions that they've approved instead. Not to mention their lack of regulation on things that they really need to regulate. But I digress.
Now, their newest victim of "I can't regulate it so I'm destroying it instead" is inflatable birthing pools for home births.
Barbara Harper, author of Gentler Birth Choices and founder of Waterbirth International explains that the FDA wants them registered as medical equipment. She says, to prevent sale of birthing pools they've gone as far as to virtually seize an incoming shipment at a dock in Portland, Oregon and may "inspect and destroy" the pools.
The FDA is requiring a 510(k) – PreMarket Authorization – to be turned in for each Inflatable Birth Pool. The problem is that there is no Pre-existing Medical Device – “Predicate” – already approved by the FDA. Hence, potential of years of clinical trials and legal fees that can cost up to a million or more. Obviously not feasible.
So, there's a way to do it if midwives were millionaire corporations. What about kiddie pools? Some women use a kid pool instead of renting/buying the more expensive, much deeper and more comfortable birthing pool. Other women opt to use their own bathtub.
This would be just about as ridiculous as claiming that cotton balls should be registered as medical equipment because doctors, dermatologists use them every single day. Single-use gloves too! How about the roll of paper you sit on in the doctor's office? Is THAT medical equipment? A birthing pool is just a large inflatable tub you fill with water, and sit in. Ooh, so scary. Birthing pools have single-use liners so that none of the fluids touch the pool itself, making it a great option for midwives who then have a new, clean pool for every client, with nothing ever touching the pool itself.
Heck, an increasing number of hospitals even allow birth and labor in their bathtubs, which DON'T have the ability to have single-use liners. The only requirement to use a tub in most hospitals is that at least 2-3 sides of it are open to allow for medical assistance to have access to the mom. So frankly, the inflatable pools are not only cleaner, but are more comfortable (some have inflatable stools and grab handles, and an inflatable bottom even), and ALSO are completely open all the way around. So again, the difference is what? Are hospital bathtubs "registered medical equipment"? Nope.
There may be some hope though. Althouse says, "One potential loop hole is a 'PreAmendment Status' product. If there was anyone in the US using birth pools (yes, troughs, tubs of any kind) prior to May 1978, we can get 'Birth Pools' grandfathered in to the FDA as an approved Medical Device. Waterbirth would have permanent legitimacy and could not be questioned any further."
Marla asks that if you know of midwives using birthing pools prior to 1978, let them know we need them! They're also looking for a high profile attorney "to highlight the ludicrous nature of this attempt at taking away women’s choices for comfort in labour."
Did you use a birthing pool? Do you consider it 'medical equipment'?
Image via Waterbirth International