FDA seizes birth pools, says need to be registered as medical equip., & threatens to destroy

[Breathless Wonder]

http://blog.cuntastic.org/2011/05/26/birth-pools-seized-by-fda-in-portland-or/

Quote:

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.

See also:

http://www.facebook.com/note.php?note_id=10150257850942082

http://www.facebook.com/note.php?note_id=10150258460847082

[goinggreengirl]

Yikes! Good thing there are plenty of blow up pools and watering troughs that will work for waterbirths. This won't stop people from having a waterbirth but it sure is ridiculous.

[Ellien C]

Just a little warning - the name of the blog and the header may not be something you'd want someone (kids, boss, etc) looking over your shoulder when you open the link. I'm at work so I need to be sensitive to these things - as we say here: NSFW (not safe for work). Some people might have similar objections if their children are around.

[_ktg_]

I doubt it is the FDA's interest to stop or halt waterbirths, seizure of unregistered medical devices is just part of their practice and there are many unregistered devices in the US which may have medical clearance elsewhere in the world (EU, Japan etc.). They do this practice to ensure the safety of patients, but these devices range from something as without harm as a birth pool,and the type of software used with MRI, or pacemakers to more invasive such as new "pill cams", implants or even type of sutures. 

There are ways to get medical devices registered and I see in looking through the discussion the individual is already working with the FDA & her lawyers to establish a pathway.  The 510(k) PMA suggestion is probably to see if the birth pool can be a spin off of an existing tub.  Though they probably could try to make a claim that should be exempt from the federal criteria as described in 21 CFR 812. 

Sorry for going off topic - but this is the area I work in...

[KempsMama]

I see your point, but what really gets my goat is that the FDA sees pregnancy as an illness.  It is NOT an illness.

[stik]

Is there any external verification of this?  I see that Barbara Harper is very upset about this situation, and there is beginning to be a lot of talk about it in various corners of the web, but all the information about the FDA and birth pools that I am finding is coming from Barbara Harper.  I can't find anything on the FDA website, including anywhere were the FDA describes pregnancy as an illness or any mentions of seizures of birth pools or their classification as medical devices.  

[mwherbs]

Others who are in the business of selling birth pools verify. There is no recall issued yet. Just a freeze on sales unil fda status is settled. So they either need a tubs are in existence/ use before they started reviewing products, and be grandfathered in like beds, surgical tables, casts, or have to show safey/low risk status...
Since blow up pools, and portable jacuzzis are in general use probably should not be considered a medical product anyway,just a portable bathing device...

[_ktg_]

Originally Posted by stik 

Is there any external verification of this?  I see that Barbara Harper is very upset about this situation, and there is beginning to be a lot of talk about it in various corners of the web, but all the information about the FDA and birth pools that I am finding is coming from Barbara Harper.  I can't find anything on the FDA website, including anywhere were the FDA describes pregnancy as an illness or any mentions of seizures of birth pools or their classification as medical devices.  

Here's a link to the event (i.e. a complaint) on the FDA's website which appears to have been working through the system since 2004.  There is not much there except that the issue is trying to determine if the "device" needs a 510(k)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=526511

I would bet that the language of pregnancy as an illness has been included in correspondence between Harper & the FDA which might not be public or posted on their website.  I'll poke a bit more around the FDA's website to see if a warning letter has been published from the FDA to Harper on this matter.

[stik]

Originally Posted by mwherbs 

Others who are in the business of selling birth pools verify. There is no recall issued yet. Just a freeze on sales unil fda status is settled. So they either need a tubs are in existence/ use before they started reviewing products, and be grandfathered in like beds, surgical tables, casts, or have to show safey/low risk status...
Since blow up pools, and portable jacuzzis are in general use probably should not be considered a medical product anyway,just a portable bathing device...

Can you provide a link to any of those others?  

When I poke around the web, it doesn't look like birth pool sales are frozen.  yourwaterbirth.com is perfectly willing to sell me one, as is waterbirthsolutionsstore.com.  

[_ktg_]

It might just be Harper's birth pools are not being sold at this time.  Though I looked at her website to see an example of the "offending" pool  and there is nothing posted regarding limited sales or availablity.

More information from the FDA regarding questions as to what they might be trying to classify this as:

Immersion hydrobath (which in the complaint - it references a similar type of device which has 510(k) clearance: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&rgn=div5&view=text&node=21:8.0.1.1.31&idno=21#21:8.0.1.1.31.6.1.2

or they could try for a nonpowered (but I doubt this since you need a current for the inflator) sitz bath.  The sitz bath is a type of device which has been grandfathered by the FDA and is exempt from of the requirements of devices (as noted in the explaination) 

[stik]

I didn't notice until just now that the birth pool in the complaint was invented by Barbara Harper.  The Harper Freestanding birth pool looks very different from what I usually think of when I think of birth pools.  I usually think of some kind of inflatable thing, maybe with a pump to inflate it and something to heat/exchange the water.  The Harper Freestanding Birth Pool looks a little more high tech.  I don't doubt Harper is having a problem with the FDA.  Certainly, I can't imagine any benefit to claiming to have a problem with the FDA when no such problem exists.  But I wonder if the problem here is really generalizable to all other birth pools, or can be considered an FDA assault on water birth.  

I think it's conceivable that the FDA has concerns about the electronics, or the acrylic resin, or the drain pump in the Harper Freestanding Birth Pool that aren't really applicable to the types of birth tubs most home-birthers are using.  

[mwherbs]

Importers of birth pools have had their shipments suspended and the most recent already on the docks stock has been cataloged and basically frozen from circulation, pending a determination by the FDA on if they are a new unique device that poses possible hazard that needs to be studied or if they can be grandfathered in or maybe not even considered a medical device. Blow up backyard swimming pools still exist as a recreation item and not a medical device...The similarity of that alone maybe enough proof that it is something in common use.. IDK

Secondary retailers may have some older stock that has not been cataloged so is not on hold yet. But if there fda finds that birth pools are unique then all may be subject to recall. What I have been told by a retailer so far... She has limited stock. She has been in contact with others and all are saying the same thing...

[_ktg_]

Quote:

Originally Posted by stik 

I didn't notice until just now that the birth pool in the complaint was invented by Barbara Harper.  The Harper Freestanding birth pool looks very different from what I usually think of when I think of birth pools.  I usually think of some kind of inflatable thing, maybe with a pump to inflate it and something to heat/exchange the water.  The Harper Freestanding Birth Pool looks a little more high tech.  I don't doubt Harper is having a problem with the FDA.  Certainly, I can't imagine any benefit to claiming to have a problem with the FDA when no such problem exists.  But I wonder if the problem here is really generalizable to all other birth pools, or can be considered an FDA assault on water birth.  

I think it's conceivable that the FDA has concerns about the electronics, or the acrylic resin, or the drain pump in the Harper Freestanding Birth Pool that aren't really applicable to the types of birth tubs most home-birthers are using.  

I saw that too and thought of course that could be a problem and the FDA might be interested in that because there were more working parts.  Then I looked back at the OP - and the acrylic one is not the one being questioned - it is an inflatable pool (AquaBorn birthing pools).  

 
MWherbs interesting that all birth pools (beyond just the Harper one in the complaint) are being held from sale & circulation.  Hopefully this will come to a resolution quick - almost 8 years to resolve this matter is a long time!

[miriam]

This is so silly.  Will the tubs in our homes or our hot tubs be confiscated also?