New Study Proves--Ameda HygieniKit Protects Breast Milk From Bacteria and Viruses*

Libertyville, IL, September 2001—There is good news for mothers who rely on electric breast pumps to provide breast milk to their babies.

The Food and Drug Administration (FDA) reviewed and cleared the claim that the patented silicone diaphragm used in the Ameda HygieniKit milk collection system creates a barrier that protects both:

1. collected breast milk from potential contaminants, such as viruses and bacteria that may be present in the pump and or kit tubing AND

2. pump and kit tubing from potential contaminants, such as virus and bacteria, that may be present in collected milk.

The Ameda HygieniKit is the only breast milk collection system with FDA clearance to make this strong protective claim.

The significance of the claim may be especially relevant to mothers using medical grade breast pumps and those pumping for premature or ill newborns who are at greater risk of succumbing to infection.

The new claim states:

*"The Ameda HygieniKit has a patented silicone diaphragm that creates a barrier protecting the pump and tubing from penetration of bacteria^{1, 2} and viruses (Hepatitis B and C and Human Immunodeficiency Virus HIV)¹ 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 bacteria^1,2 and viruses (Hepatitis B and C and Human Immunodeficiency Virus HIV)¹ from the pump and tubing in the event of contamination of these components during a prior use or by a prior user.

“Note that the Ameda HygieniKit neither removes bacteria and viruses (Hepatitis B and C and Human Immunodeficiency Virus HIV) 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.”

¹ The use of this product neither guarantees or warrants against the transmission of Hepatitis B and C and Human Immunodeficiency Virus HIV.

² Testing performed in situ using actual HygieniKits and SMB Piston Breast Pump with suspension of Phi-X174 bacteriophage and Escherichia coli, Staphylococcus pneumoniae and Pseudomonas aeruginosa. Procedure was adapted from ASTM 1671-97b “Standard Test method Resistance of materials Used in Protective Clothing to Penetration by Blood-borne Pathogens Using Phi-X174 Bacteriophage as a test System.”

Note: Testing relating to this claim applies to stock numbers: 17121, 17126, 17131, 17101, 17111, 17128, 17070, 17072.

Ameda breastfeeding products are manufactured by Ameda AG.