5.26.2011

The FDA is Having a Pool Party

www.richmondmidwife.com
And we weren't invited.

This morning I got onto Facebook to read that Barbara Harper posted a note. The information within it floored me.

The FDA has confiscated a shipment of birthing pools and is holding them.

These pools were destined for a company that sells many home birthing supplies that are medical and non-medical, where they would then be distributed to the women who purchased them for a water birth..   

The directives are clear: they will be destroyed or shipped out. Their reasoning? They are stating that birth pools are medical equipment.

The FDA says that birth pools are unregistered/unapproved medical equipment... really? REALLY?
"Got a kiddie pool in your house?  Watch out!  The FDA may be coming after you!   No… seriously, they might be knocking on your door to seize your unregistered medical device! No joke!" - Danielle from Being Pregnant
I think we should flood the FDA with requests to approve all other 'medical equipment', including: birth stools, my kitchen chair, washcloths, regular baths, shower heads, fish nets, submersible pumps, toilet, breast pump, bed, dining room floor, kitchen floor, rocking chair, sofa, ice maker, rice sock, Tingler, rebozo and husband... oh, and let's not forget ME! (not really, but this is my knee-jerk reaction).
"And therefore since one arm of the U.S. government believes that pregnancy is an illness and birth is a medical event and anything that is used during this time is considered a device that needs to be approved by the FDA, what is the next option/choice to go?" - Childbirth Today
This just fumes me... and I hope it does you too!

So, the federal government now consider birth a medical event... As far as I knew, it was state by state whether legislature considered childbirth a medical event or not (i.e. midwives practicing medicine without a license or simply providing a service).

Additionally, the very DEFINITION of medical is: Relating to the science or practice of medicine...

Likewise, the definition of medicine is: The science or practice of the diagnosis, treatment, and prevention of disease (in technical use often taken to exclude surgery), or a drug or other preparation used for the treatment or prevention of disease...

So MEDICAL EQUIPMENT means: equipment related to the science or practice of the science, or practice of the diagnosis, treatment, and prevention, of DISEASE!...

uh... childbirth is NOT A DISEASE!

Laurel Ripple Carpenter quickly got a blog post up and running, seeking to inform others about this issue and to rally support.
According to Barbara Harper, author of Gentle Birth Choices and 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 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.
How to Help
Martha and Barbara need help – specifically, a high profile attorney and support from any midwives who were practicing waterbirth before 1978.
“If you know of anyone practicing waterbirth prior to 1978, please let them know we could use their help,” Martha pleads.  That would be the only way to establish birth pools as eligible to be grandfathered in.  Also, “We need a high profile attorney to highlight the ludicrous nature of this attempt at taking away women’s choices for comfort in labour,” explains Barbara.
This whole thing seems pretty baffling, and I still find myself wondering if it could possibly be real.  But evidently, according to several trusted names in the birth world, it is.  So let’s get on it–Facebook, Twitter, and your whole Rolodex full of powerful connections.  Hit ‘em up.
See the original note here. See the follow up here, then go to Enjoy Birth's Blog to vote on if birth pools should be considered 'medical equipment'.

UPDATE: Here is the followup post. Please help us take what positive action we can to get these birth options back into the hands of the women who need them.

6 comments:

SolaceMama said...

I have no connections to send you but my gut says Ina May would be able to help you.

This is just ludicrous!!!

Amanda said...

Oh you are right Cole, I don't like your blog one iota.

Anonymous said...

You forgot the yoga/birthing ball... and pillows, swaddling blankets, breasts? My last birth was in a hospital and they treated me like I had a communicable disease! Gloves, gowns, face-masks, hair nets, strapped to a bed with tubes and monitors... why do they make birth so much harder than it needs to be?? Now they're taking away the very tools that delivered hundreds of generations of people before 'modern medicine' regulated everything! FDA... I have a few choice words to describe that acronym!

.tasha said...

i got my pool from waterbirthsolutions for my water birth in march. i'll be praying for this because it's just crazy how controlling things are for you ladies across the border! i can't even imagine how frustrating it must be to have your choices threatened like this!

Anonymous said...

What do you mean Tasha? Where are you?

kathy said...

As far as I can see, the FDA is only seizing Barbara's pools. All other pools are still for sale. Why are they only seizing hers? Why were her company's pools reported as a hazard to the FDA? There is a MAUDE report on her pools. So, there was something that someone was concerned about. Until you get to the bottom of that, then you don't know what is really happening and why.

Some pools are reported as being made without hazardous chemicals that could leach into the body during labor. Are Barbara's perhaps not? Could they be made from toxic vinyl?

What is really going on here?

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