The Nanny State has found one more area to stick their nose where it doesn’t belong.
I am a veteran of one hospital birth and two water births at home. For my first home water birth, I used a rented birth tub that was 5 feet in circumference. While I loved the buoyancy it provided, I discovered it was a bit too large for a short person like me.
For my second home water birth, I opted for a large feed trough because it was long and narrow and I could use the rails for support. We padded it with blankets and lined it with a huge plastic tarp before filling it with warm water. The weightlessness took the pressure off my back and enabled me to get into comfortable positions more easily.
The fact is, birth tubs are NOT “medical devices”. They are comfort measures to make labor and delivery more comfortable for the mother. During labor, I’ve used other comfort measure such as a hot shower, an exercise ball, hot compresses, and aromatherapy. I’ve known mothers who used a hot rice sock, massage, ice, soothing music, and other comfort measures. Should all these be confiscated and regulated as “medical devices”, as well?
According to Barbara Harper, author of Gentle Birth Choicesand founder of Waterbirth International, the FDA has seized a shipping container of AquaBorn birthing pools at a dock in Portland, Oregon, and have ordered agents to “inspect and destroy.”
“They claim they are unregistered medical equipment, but they are not providing a way or means to get them registered. In other words, if the medical authorities can’t stop waterbirth, then just have the FDA take away the birth pools,” she explains in a lengthy discussion that began yesterday.
While birth pools are imported to Canada under the category “paddling pools” and some are imported here in the U.S. under the category “sitz baths,” they have no legal standing as medical equipment at this time.
But why would they? They are often purchased or rented for personal use in private homes. Barbara’s conversation with an FDA official may shed some light on this as a clash of perspectives. She explains that she was told, “Pregnancy is an illness and birth is a medical event. Therefore, a pool that a woman gives birth in should be classified as medical equipment.” So what about our toilets, our bathtubs, our showers? Kiddie pools, horse troughs, hot tubs? Oh, and what about the fact that pregnancy is *not* an illness?
What the FDA Wants
Martha Blackmore Althouse, owner and manager of Waterbirth Solutions in Beaverton, Oregon, has been interacting with attorneys and the FDA on the issue. She explains:
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.
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.
So it seems that there could be a solution to this, but not before enduring a long process full of red tape and bureaucracy.
Carpenter maybe a liberal activist, but on this issue we can agree. The government has NO business interfering with women who are exercising their right to a safe, intervention-free home birth!