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. Â For my first home water birth, I used a rented birth tub that was 5 feet inÂ circumference. Â 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. Â We padded it with blankets and lined it with a huge plastic tarp before filling it with warm water. Â 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”. Â They are comfort measures to make labor and delivery more comfortable for the mother. Â During labor, I’ve used other comfort measure such as a hot shower, an exercise ball, hot compresses, and aromatherapy. Â I’ve known mothers who used a hot rice sock, massage, ice, soothing music, and other comfort measures. Â Should all these be confiscated and regulated as “medical devices”, as well?
According to Barbara Harper, author ofÂ Gentle Birth Choicesand founder ofÂ Waterbirth International, the FDA has seized a shipping container of AquaBorn birthing pools at a dock in Portland, Oregon, and have ordered agents to â€œinspect and destroy.â€
â€œThey 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 canâ€™t stop waterbirth, then just have the FDA take away the birth pools,â€ she explains in a lengthyÂ discussion that began yesterday.
While birth pools are imported to Canada under the category â€œpaddling poolsâ€ and some are imported here in the U.S. under the category â€œsitz baths,â€ they have no legal standing as medical equipment at this time.
But why would they?Â They are often purchased or rented for personal use in private homes.Â Barbaraâ€™s conversation with an FDA official may shed some light on this as a clash of perspectives.Â She explains that she was told, â€œPregnancy is an illness and birth is a medical event. Therefore, a pool that a woman gives birth in should be classified as medical equipment.â€Â Â So what about our toilets, our bathtubs, our showers?Â Kiddie pools, horse troughs, hot tubs?Â Oh, and what about the fact that pregnancy is *not* an illness?
What the FDA Wants
Martha Blackmore Althouse, owner and manager ofÂ Waterbirth Solutions in Beaverton, Oregon, has been interacting with attorneys and the FDA on the issue.Â She explains:
The FDA is requiring a 510(k) â€“ PreMarket Authorization â€“ to be turned in for each Inflatable Birth Pool. The problem is that there is no Pre-existing Medical Device â€“ â€œPredicateâ€ â€“ already approved by the FDA. Hence, potential of years of clinical trials and legal fees that can cost up to a million or more.Â Obviously not feasible.
One potential loop hole is a â€œPreAmendment Statusâ€ product. If there was anyone in the US using birth pools (yes, troughs, tubs of any kind) prior to May 1978, we can get â€œBirth Poolsâ€ 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. Â The government has NO businessÂ interferingÂ with women who are exercising their right to a safe, intervention-free home birth!