Showing posts with label waterbirth. Show all posts
Showing posts with label waterbirth. Show all posts

5.27.2011

A Chance To Make a Change

I just finished up writing a quick post on the FDA seizing birth pools that arrived in the U.S. and were slated to be delivered to home, birth center, and hospital birthing women around America.

Since the original notification, and as passion and frustration continues to mount, I ask that we take a moment to consider the implications of our words and actions. 

How can we help?
  • First off, let me say that the best help we can be for the business owners and companies who are being impacted by this action is not to bombard them with questions, phone calls, and emails. They are, no doubt, working hard to try to find resolution to this issue while also helping to maintain women's options and access to water birthing pools. This is undoubtedly a frustrating time, and our impassioned words should be tempered (myself included) with prudence and wisdom.
  • Second, until there is resolution, we should not stoke the fires of panic. Instead, reduce, reuse, recycle. Have a birth pool in the attic? Consider offering it to other women in your community who are planning on a water birth. Have extra liners? Share. Run out of liners? Use California King mattress covers as liners. :) Until this is resolved, we know that our access to birth pools will be limited, so let's rally support for one another. 
  • Third, write NON-HOSTILE letters to our state representatives and on our own social media sites encouraging positive change and support for these companies and the women they serve.  
  • And last, if you KNOW someone who has had a water birth in what might be able to be considered a water birthing POOL/TUB before 1976, PLEASE have them contact Barbara Harper so that she can get you both in contact with those who could use the information to attempt to grandfather the birthing pools in.

Our focus should be to elicit positive change, while also influencing the powers that be to consider the implications of limiting women's birthing options. Just as midwifery that was outlawed simply forced midwives underground... and outlawing home birth just forced home birth underground, so would, ultimately, strictures on birth pool availability.

The goal, then, should be to make sure that we don't allow it to get to that point.

Taking a cue from the Big Push and other organizations that have much experience in birth option government limitations, I recommend that we begin a letter writing campaign to the state legislatures that can lobby on our behalf to reign in the FDA, release our birth pools, and start a positive discourse for resolution to this issue so that it does not come up again.

This might mean that we have to come up with a classification of approval in order to retain active access to our birthing options. But, in the mean time, let's get our birthing pools back into the hands of the women who they benefit.
"The use of water as an option, a choice, a way of receiving comfort in labor, has always been for me, a platform upon which I stand to have a conversation about birth - all aspects of birth.  I don't really care what pool one uses, or where that birth happens, as long as the birth AND the baby are respected.  Do I have personal preferences?  Of course, but there is a joy that happens when I see waterbirth introduced into a hospital and the cesarean rate drops or when other practices change in the hospital after the staff witnesses the power of undisturbed birth.


I firmly believe we can continue to use this platform to talk about all the issues that plague us today and stop the polarization of home versus hospital, CNM versus CPM, OBs versus midwives.  All women deserve the choice of undistrubed birth and how we come together to make that happen will be the deciding factor.  Let's use this current confrontation to our best advantage and form a united movement to insure that waterbirth, midwifery, home birth, and undistrubed birth in any setting by any provider remain options for all women, all babies and all families throughout the US and around the world." - Barbara Harper
The Letter
Please see the letter below and feel free to cut/paste/modify as you see fit.

Then, send it..

send it to your local representatives, Tweet it, FaceBook it, and email it to your friends, peers, and coworkers.
Dear ______________________,
I’m writing in response to the recent FDA's hold on a shipment of birthing pools destined for pregnant women who were looking forward to using them during their labors and/or births.

The FDA has placed a detention on incoming shipments of portable birth pools and have given the distributors/manufacturers various deadlines for compliance. The FDA claims that these pools are unregistered medical equipment, but they are, as of yet, not providing a way or means to get them registered.

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, we are potentially looking at of years of clinical trials and legal fees that can cost up to a million or more.

While a new classification is being drafted, outlined, and implemented, numerous women around the United States will be without birthing pools, a very valid means of labor pain management utilized by many of the home birth community and some of the birth center and hospital community.
As taxpayers and as mothers, we find it unacceptable that our choices are being limited by the restrictions and detention of these pools as set forth by the FDA.
The option of water birth has been shown in numerous medical studies to decrease the use of medical intervention, which, in turn, reduces the incidence of cesarean and iatrogenic risk, resulting in healthier and safer labors and births. Additionally, with health care costs rising, the use of something as simple as a birthing tub can drastically reduce the costs associated with childbirth.

By limiting, even short-term, women’s access to inflatable pools used in labor and birth, the FDA is seeking to limit access to a safe and effective means for reducing risk during the process itself.

Additionally, the very definition of medical equipment is debatable. Should toilets, rebozos, couches, and physical therapy balls be subjected to FDA approval for the act of birth? Like birth tubs, these are all routinely used in healthy, normal pregnancy and births. Should these also be considered durable medical equipment and be regulated?

The term, medical, is defined as: 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.

As such, medical equipment would be defined as: equipment related to the science or practice of the science, or practice of the diagnosis, treatment, and prevention, of disease.

The use of birth tubs are, in most cases, reserved for the healthy and low-risk birthing woman. As such, her care does not automatically fall under the classification of a medical event and birth pools should not be denoted under the classification of medical equipment.

We urge you to advocate for the women within your communities; women who are giving birth and who have a right to safe and effective health care.

Please support us in allowing the birthing pools that have been confiscated by the FDA to be distributed to their rightful owners. Help us also then to work with the FDA, the manufacturers of these pools, and the caregivers who assist us during our labors, to come to a consensus as to how to move forward, without putting restrictions on our safe birth practices in the process.

Sincerely,
Cole Deelah
Supporter of Women’s Birth Options
and mother of five beautiful children

You can send this letter by email, by mail, or by hand to your local representatives.
  • If you are in Texas, reach out to your legislatures here
  • If you are in Michigan, see here
  • If you are in Tennessee, see here.
  • If you are anywhere else and need help finding out who your representatives are, see here.

Remember, this is time sensitive. Change is inevitable, let's make sure that it is good change.

UPDATE: please note there has been an update on everything! The pools have been released to the company that had them shipped in, but the FDA has told them they are not to sell them. The companies are still working with the FDA to be able to reach their personal deadlines of compliance and are attempting to work out a reasonable solution for the future of water birth pools.

Our letter writing campaign is still very important! Please continue to contact your local representatives, but consider changing the verbiage to reflect these updates.

Please read Laurel's follow up post here for more information.

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.

7.10.2008

Waterbirth in the Hospital

This is what we could have here in Nashville, TN. We have a great, big, teaching hospital with a great, big, multi-million dollar high risk maternity wing... you would think we could have a few, just a few, waterbirth rooms on campus. This is what we could have.

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