Birth Pool Accessibility Now in Question

If you are a birth professional, you will know how quickly the news about the FDA making accessibility to birth pools in the U.S. harder went viral today (5/26/11) .   The following is  information from long time expert and waterbirth advocate Barbara Harper: 




"In my personal conversations with a woman(Patricia Jahnes) in the "Office of Compliance- Center for Devices and Radiological Health" (that's where they put us) I was told in no uncertain terms that pregnancy is classified as an "illness" and "birth is a medical event" and therefore ANYTHING that is used during this time is considered a "device" and therefore needs approval by the FDA". ! BH


There is a flaw here in their (the Office of Compliance) reasoning.  A huge flaw.  So if 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, then what about Foley catheters used for Foley Inductions rather than for urinary flow?  What about Cytotec that is used frequently but not approved for use during pregnancy and birth?  And what about the inconvenient truth that both the electronic fetal monitors and the Apgar scoring system were never intended to be used in the manner that they are today?


I realize that these may be the difficult and unpopular questions.  However, I also realize that many of a woman's options and choices in pregnancy and childbirth are under attack.  


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?