“The Ameda HygieniKit has a patented silicone
diaphragm that creates a barrier protecting the pump and
tubing from penetration of bacteria1, 2 and viruses (Hepatitis
B and C and Human Immunodeficiency Virus HIV)1, 2 from
contaminated liquids inside the collection bottle system.
The diaphragm in this product creates a barrier protecting
liquids collected in the collection bottle system from
penetration of bacteria1, 2 and viruses (Hepatitis B
and C and Human Immunodeficiency Virus HIV)1, 2 from
the pump and tubing in the event of contamination of
these components during a prior use or by a prior user.
The Food and Drug Administration (FDA) has reviewed
and cleared the claim that the patented silicone
diaphragm used in the Ameda HygieniKit milk collection
system creates a barrier that protects both:
A. collected breast milk from potential contaminants
such as viruses and bacteria that may be present
in the pump and kit tubing, and
B. pump and kit tubing from potential contaminants
such as viruses and bacteria that may be present
in collected breast milk.
Note that the Ameda HygieniKit neither removes bacteria
and viruses (Hepatitis B and C and Human Immunodeficiency
Virus HIV)1, 2 from the breast milk being collected into the
collection bottle nor does the Ameda HygieniKit make it safe
for infected mothers to feed their infants with milk collected
using this device.”
Study Results
An independent laboratory study was conducted testing the Ameda
HygieniKit and the ability of its patented silicone diaphragm to act
as a two way barrier to viral and bacterial contamination.3
Simulating severe use conditions, the Ameda diaphragm
was tested for its ability to act as a barrier to bacterial and
viral penetration. Representative bacteria and virus selected
to challenge the barrier properties of the diaphragm.
The challenge suspension was placed on either side of the
Ameda HygieniKit silicone diaphragm to simulate contamination
either from vacuum pump or tubing, or from liquids inside the
collection kit itself. The HygieniKit was then attached to the pump
and vacuum was applied.
After one hour, the sides of the diaphragm opposite the
challenge suspensions were rinsed with a nutrient broth which
was cultured for penetration. Positive and negative controls
were used.
In all replications, bacteria and viral penetration through
the diaphragm was not detected in either direction.
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