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Subject:
From:
"Walt Puckett, Medela" <[log in to unmask]>
Reply To:
Lactation Information and Discussion <[log in to unmask]>
Date:
Mon, 9 Sep 1996 20:55:22 -0400
Content-Type:
text/plain
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Regarding Rose Marie's and Debi Page's postings about Pump Trials, I want to
add a few comments. I am the Western Region Sales Manager for Medela and
practiced hospital pharmacy for 15 years prior to going into sales.  I have
sold Medela products for over 11 years and the subject of pump trials has
come up from time to time.  The liability issue Debi brings up is most
important here.  A lactation professional may use their best judgement in
attempting to prevent contamination of "single patient use designated (FDA)"
equipment from mother to mother yet, as Debi mentioned, they could be put in
the position of "proving" that the pump trial was NOT the cause of some
acquired infection.   There is really no such thing as proof that something
is
"sterile," only proof that something has been exposed to "sterilization
conditions."
In the case of Medela kits, it means either steam or gas autoclaving, and our
kits are both steam and gas autoclavable.  Medela rental stations and retail
outlets are covered by a multi-million dollar product liability policy as
long as products are used according to its directions.   Medical products
that are used to come in contact with the human body are very strictly
regulated by the F.D.A.  I would recommend that you have substantial medical
practitioner liability insurance if you are using medical products from this
and other manufacturers, and are not showing proof that you have exposed the
plastic parts to sterilization conditions.  As Debi mentioned, the metal
instruments are soaked in alcohol or another "disinfectant" to attemp to
protect the health care workers prior to the sterilization procedure which
protects the next patient.   Some rental stations are considering selling the
mother a Lactina double pump kit which allows them to trial the Lactina with
their own kit.  The mother must purchase a kit, but that kit may now be used
to connect her to either a Lactina or a Pump in Style Basic.  It also
provides her with a great hand pump.  Hope this helps.

Walt Puckett, B.S. Pharmacy, R.Ph., Medela Inc.

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