Response to Sakamoto et al.

Dear Editor:

Although there is no debate about the growing demand for human milk, Sakamoto et al. ¹ seem to support maintaining the milk banking status quo as opposed to embracing innovative efforts to increase the availability of donor milk, failing to consider the real risk many preterm babies face should the current scarcity continue.

How many babies will die of necrotizing enterocolitis or survive in a diminished capacity if we wait, as Sakamot et al. ¹ suggest, for some unidentified group of researchers, healthcare professionals, milk processing entities, public health professionals, and mothers to make the sweeping changes needed in milk banking practice? Our community needs to embrace new solutions to solve long-standing problems, even if that means going beyond vested interests. As innovators, we have made an enormous effort over the past 4 years to address these problems, with well over a million dollars spent developing improved processing methods. Our groundbreaking work on the development of the donor-owned Mother's Milk Cooperative with the help of a U.S. Department of Agriculture Cooperative Development Grant stands as one of the most meaningful advances in milk banking practice in decades. Medolac's partnership with the American Red Cross National Testing Laboratories has brought donor testing to a new level, and the Cooperative's national partnership with Labcorp facilitates blood draws for donors in virtually every community.

I think we can all agree that donor milk is the “gold” standard, but vexing quality concerns, high cost, and scarcity still prevent widespread access as a standard part of neonatal and pediatric critical care. These chronic milk banking challenges merit discussion and collaboration.

Milk quality is measured by looking at both composition and hygiene. A standard method of measuring hygiene has always been microbiological screening. Some milk banks, however, have discontinued preprocessing screening or do so only occasionally or for a particular donor. Instead, they argue, testing the final product provides enough assurance of a successful pasteurization process. This disturbing trend represents a risk to donor milk safety due to several pathogens commonly found in breastmilk, including Staphylococcus aureus, Bacillus cereus, and Pseudomonas aeruginosa.

Without preprocessing cultures, donor milk with unacceptably high levels of these pathogens may be processed, leaving residual endo- or exotoxins that cannot be removed by pasteurization. Methicillin-resistant S. aureus has been identified in human milk. ² In one published report, three outbreaks of S. aureus from breastmilk in a neonatal nursery resulted from an infected milk bank worker. ³

B. cereus is especially alarming because pasteurization does not eradicate it. A heat-resistant spore-former, B. cereus has caused severe opportunistic infections in neonatal units and is commonly found in breastmilk. ⁴ The ability of B. cereus to form biofilms on surfaces causes contamination problems within the food industry ⁵ and has been cited by The Mothers' Milk Bank at Austin (Austin, TX) as a “predominant contaminant in pasteurized donor milk, particularly problematic during donor human milk banking and something that must be examined for and dealt with systematically by milk banks.” ⁶ B. cereus biofilms cannot be removed from glassware by autoclaving. Hospitals that are considering establishing their own milk banks with on-site processing should be made aware of this very serious shortcoming of Holder pasteurization.

At Medolac Laboratories, we have developed processing methods that eliminate B. cereus and other pathogen threats and result in donor milk that is commercially sterile and shelf-life stable at room temperature. In a spirit of collaboration, we have extended an offer to process milk for tax-exempt milk banks at a cost that is far lower than their present costs, with the hope that such economic advantages will encourage them to provide a safer form of donor milk at a reduced price.

Regarding the cost of donor milk, Sakomoto et al. ¹ incorrectly assume that the price of donor milk will rise if donors are paid. This is not the case. Paying donors for their milk has already had the desired effect of radically increasing the volume of raw milk provided by qualified donors. High volume drives lower processing cost, which results in a lower selling price. Mother's Milk Cooperative donor milk has been introduced to the market at a price that is 20% less than that from tax-exempt milk banks and more affordable than any other source worldwide. Additional savings are realized because the product is shelf-life stable and does not require frozen storage or overnight shipping.

We must not forget the mission we all share—to make donor milk safe and accessible to every baby in need. Regardless of how efforts happen to be structured, tax exempt or tax paying, or whether we think donors should be paid for their milk or compelled to give it free of charge, making room for diversity and innovation in the way we approach milk banking has the potential to do the most good, especially when considering the massive amount of work that is yet to be done to safely close the access gap.