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Vegetative cells, spores and toxins can and do survive pasteurization. Medical professionals may be unaware of the differences between commercial sterility and pasteurization and the methods used by process authorities to professionally process a wide range of food, now including human donor milk. This article is intended to guide the medical professional through the technical and legal aspects of thermal processing methods as well the scientific literature that supports the need for commercially sterile milk for fragile neonates. The foundation for the next generation of human donor milk products is commercial sterility. My company made this decision to improve safety for preterm infants as well as the economy of scale and ease of use by adopting the same professional processing method utilized by the infant formula industry for many years to process commercially sterile preterm infant formula. The process is not new, nor is it experimental. Since introducing Co-Op Donor milk, over 1,000 preterm infants have received the product with good results. Growth and tolerance studies are complete and data will be released shortly. This type of process has never been used for human milk only because there has never been enough volume of donor milk to make it possible. Click here to request this document..

Hospital value analysis has evolved from what was a simple exercise in optimization of resources to today’s more comprehensive model which includes a range of analytical touch points including quality, safety, infection control, reimbursement, cost, sourcing, and health outcomes, including technological and procedural evaluations. As hospitals seek products that provide the best clinical and financial value, new or expanding product offerings require more extensive scrutiny and evaluation. Donor human milk is one such product area experiencing a sharp increase in usage driven by the growing evidence of patient benefits. But donor milk from different sources are not equal since procedures for donor testing and qualification, milk quality and safety testing and milk processing methods differ greatly and often lack validation or verification. Hospital decision makers may not be aware that basic food safety guidelines are sometimes not followed by small processors simply because they lack technical capacity and the equipment necessary to take such measures. For example, small processors have been known to thaw frozen milk at room temperature and lack the cleaning, safety processes and expertise needed to avoid biofilm formation on equipment. Although not required by law, donor milk processors should look to relevant parts of the Pasteurized Milk Ordinance for guidance or adopt other suitable global standards that require pre-process microbiological screening. Click here to request this document.

The chronic shortage of donor milk has triggered widespread rationing to such a degree that many preterm babies are now being denied access because they don’t fit into the narrow definition of babies who “qualify”. Mounting evidence of short and long term improved outcomes has prompted more neonatal units to use donor milk when mother’s milk supply is short or unavailable.1 While they are unable to meet the growing demand, community milk banks are asking legislators to create new laws that could very well violate anti-trust rules. These new laws would attempt to prevent mothers from sharing their milk outside the tax exempt milk banking system while refusing to acknowledge the legitimate role of commercial milk banks. In an attempt to maintain a steady supply, hospitals are now forced to place numerous small orders at multiple milk banks across the country. Even so, they often receive only a fraction of what they ordered. In the desperate race to procure human milk, the question of quality and safety is not given sufficient scrutiny.

This is a copy of an article published in the Breastfeeding Medicine © 2013 copyright Mary Ann Liebert, Inc.; Breastfeeding Medicine is available online at: http://online.liebertpub.com.

Human milk banking was virtually discontinued at the start of the human immunodeficiency virus era amid fears that the virus might be transmitted to preterm infants receiving donor milk. However, the demand for donor breast milk has continued to be driven by decades of research that have increasingly demonstrated the benefits of breast- milk in neonatal care regarding the reduction of life- threatening necrotizing enterocolitis and infection, as well as improving long-term outcomes, notably neurodevelopment and bone health. Despite the progressive return of milk banking during the past two decades, the demand for breast milk has not been met. Now, this problem has been greatly compounded by a recent, radical increase in demand for human donor milk resulting from compelling new research that is changing the standards for how preterm infants are fed. .Click here to request this document.