The Medolac Difference
Vegetative cells, spores and toxins can and do survive pasteurization of donor milk.
Milk testing pre-process is vital but many medical professionals are unaware of the differences between commercial sterility and pasteurization. Bacillus cereus is a pathogen of particular concern in milk banking, that can survive pasteurization - but does not survive the process used by Medolac for our commercially-sterile products.
There are many technical and legal aspects of thermal processing methods as well scientific literature that supports the need for commercially sterile milk for fragile neonates. Maintaining high levels of quality of human donor milk is essential for for highly vulnerable infants. Medolac is an evidence based organization offering the most rigorous Milk Banking Safety and Quality Program on a global level.
These standards include testing all milk that enters the processing plant before processing, for a variety of safety and quality factors.
Donor Screening
Breast milk donors to a Medolac affiliated milk bank must successfully complete a detailed medical history questionnaire and blood screening. Medolac breast milk donors must be found negative for the blood tests listed below. To continue providing donor milk, donors must repeat this process every six months.
Raw Milk Screening
Any donor breast milk that does not meet Medolac quality standards is immediately segregated. The person who provided such donor milk is contacted and an interview is performed to help her determine the cause of the problem. At Medolac, less than 10% of all shipments do not meet our Quality Standards.
Milk Processing
Medolac frequently conducts on-site microbiological inspections of our processing areas, equipment and ventilation systems. Proper monitoring and cleaning procedures are critical to prevent development of biofilms. Additionally, Medolac employs the use of a Class 100,000 clean room for milk handling and processing.
Milk Quality
Co-op Donor Milk is commercially-sterile and homogenized. According to available data homogenization may help reduce clogged feeding tubes and may improve fat absorption in preterm infants,
Medolac processed donor milk is the ONLY donor milk that is commercially-sterile. This renders the milk free of: Microorganisms capable of reproducing in the food under normal non-refrigerated conditions of storage and distribution and viable microorganisms (including spores) of public health significance.
Packaging
Medolac uses BPA-free packaging fo all products. Each product is labeled with a Nutritional Facts Panel with full traceability on each human milk product through use of electronic record keeping from donor to recipient when the Medolac Milk Tracking Module is employed.
This module is available for NICU use through a partnership with SafeBaby, and is in Compliance with GS1 Healthcare Data Standardization. Contact SafeBaby for additional information on milk tracking in the NICU.
Nutrient Retention
With excellent retention of critical human milk components, Medolac is pleased to supply information about amino acid content, immune factors, micro and macro nutrient composition.
The heat process utilized by Medolac involves shorter time, with higher temperatue when compared to Holder Pasteurization methods. Duration of time exposed to heat is one the most destructive aspects to the bioactive components of human milk.
Additional Resources
Quality and Safety Indicators for Human Milk and Donor Milk Use in the NICU
A summary of food safety issues and regulations for human milk and human milk products.
Increasing The Global Supply and Availability of Donor Breast Milk
An overview of current challenges in addressing the need for human donor milk and human milk products on a global level
U.S. Code of Federal Regulations, Pasteurized Milk Ordinance
Standards of identity for milk and whey ingredients as part of the U.S. Code of Federal Regulations.
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Codex Alimentarius Commission, created by the World Health Organization (WHO) and the Food and Agriculture Organization (FAO)
It serves as a source for international standards, codes of practice, guidelines, and recommendations with respect to food safety and food production. Not only does it cover ingredient standards, but it also provides standards on the feeding of special populations.
FDA Working Group on Banked Human Milk.
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