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Subject:
From:
"Cindy Curtis, RN, IBCLC" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 5 Mar 2001 20:27:43 -0500
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text/plain
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Chris and others:

The pump in style is a single use pump as you said.

I  have been in contact with the FDA regarding the  sale of used
breastpumps. According to the FDA, if a breastpump is labeled a "single
user" or "single patient" device, that pump is only intended for one user
and cannot legally be resold. By selling a pump that has been designated
"single user" by the FDA, the pump is not being used in accordance with the
FDA and is being "mis-branded," which is against the law, and the FDA could
take action.

The reason the FDA designates many breastpumps as "single user" devices, is
that there is no complete way to clean certain pumps to ensure that the
breastmilk of the original user is not still within the pump system. Because
some diseases have been shown to exist in breastmilk, the possibility of
transmitting diseases through a used breastpump does exist, although it
appears that no such cases have been documented.

I have the phone number and e mail address of the lady I talked to at the
FDA if you wish to contact her yourself.

I got involved in researching this because of questions a client of mine had
too.

To my knowledge there is no sterilization kit for the pump in style, you can
boil the set up and that will be sterile but there is no way to sterilize
the actual pump in the bag.

Cindy

~**~**~**~**~**~**~**~**~**~**~**~**~**
Cindy Curtis, RN, IBCLC
mailto:[log in to unmask]
http://www.breastfeedingonline.com

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