By Teresa Kovarik, MD, FAAP, FABM, Medical Director of HealthPartners’ Lactation Services and Pediatrician at HealthPartners Como Clinic; Pamela Heggie, MD, IBCLC, FAAP, FABM, Director of Breastfeeding Medicine and Pediatrician at Central Pediatrics; and Nancy Fahim MD, FAAP, University of Minnesota, Neonatology at Maple Grove and North Memorial Hospitals
The AAP strongly supports breastfeeding for all infants given the substantial evidence showing improvement in health outcomes for babies fed human milk. In the 2012 policy statement about human milk, the AAP states that breastfeeding is a public health issue, not just a lifestyle choice. While mother’s own milk is preferred, some women have a low milk supply and, despite their best efforts, cannot meet their baby’s milk requirements. In some studies, only 30 percent of women who deliver premature infants can produce a full milk supply for their NICU babies. As we all know, mothers with full term infants can have similar difficulty. When supplementation is needed because of maternal low milk supply, pasteurized donor human milk is increasingly being used to bridge the gap.
Concurrently, there has also been a rise in informal milk sharing in our state and nationwide. This is being driven by increasing awareness of the benefits of human milk by families. Many women with a low milk supply turn to informal milk sharing from family and friends and there are a growing number of websites on the internet where human milk may be purchased.
The AAP and FDA strongly discourage informal milk sharing due to the documented risks of bacterial contamination from improper handling, storage and shipping of non-pasteurized donor human milk. Caution is also raised because of the risk of infectious disease transmission through donor milk when donors are not carefully screened before milk sharing occurs and milk is not pasteurized to assure safety. Additionally, there have been reports of internet purchased human milk being contaminated or diluted with cow’s milk.
The demand for safe donor milk is also increasing in Minnesota as the importance of human milk for both the preterm and term infant is better recognized by health care providers, hospitals and families. Currently, there are 14 Baby-Friendly hospitals in the state where the “Ten Steps to Successful Breastfeeding” are implemented to follow maternity care best practice as outlined by the World Health Organization. These hospitals account for 30 percent of the births in Minnesota.
In addition, the Joint Commission now requires all hospitals to report their exclusive breastfeeding rates, which is also driving the increased use of pasteurized donor human milk.
To address this increasing demand for safe donor milk, there has been a 5-year effort in Minnesota to establish the first human donor Milk Bank in the state. Breastmilk for Babies is a non-profit organization that has achieved the status of “Developing Milk Bank” with HMBANA, the Human Banking Association of North America. The mission of this local statewide organization is to raise funds to establish the Minnesota Milk Bank for Babies, set to open in the fall of 2018 in the Twin Cities.
Currently, hospitals and families must purchase pasteurized donor milk from milk banks in other states. Also, women in Minnesota with abundant milk supplies who want to donate their excess milk must do so by shipping their milk to out of state milk banks in Iowa, Illinois, Colorado, Ohio, Oregon and Montana. Mothers often express a desire to help babies locally. Accordingly, the goal of the new MN Milk Bank for Babies is “helping babies close to home.”
The use of pasteurized donor milk in Minnesota has been following national trends. Prior to 2010, MN hospitals primarily used donor milk for premature infants in the NICU and it was rarely, if ever, used for healthy, full-term newborns in the Mother-Baby Units. Since then the number of hospitals using pasteurized donor human milk has grown significantly. In 2018, over 20 Minnesota hospitals have a donor milk program in their well newborn Mother-Baby Unit (in addition to NICU use).
For hospitals wanting to start a donor milk program, there is a donor milk toolkit available on the MN Breastfeeding Coalition website.
The toolkit provides sample documents that can be modified for individual hospital use, including a sample policy for human donor milk, consent forms, and a patient education handout. There is also information about setting up a donor milk collection site (milk depot). Currently, there are 8 milk depots throughout Minnesota (with 3 additional sites pending). These depots are milk collection sites where mothers can drop off surplus breastmilk for donation to a milk bank.
How Does Milk Banking work?
The process of ensuring safe pasteurized donor human milk involves many steps and differs significantly from informal milk sharing. In order to eliminate the risks of bacterial contamination, drug exposure or viral infection, a strict multistep screening protocol is implemented by the milk bank before the milk is accepted for pasteurization. First, there is a verbal telephone screening of the potential milk donor by milk bank staff. Then a written questionnaire is completed, including a health history, smoking, alcohol and drug history, and a review of medication and herbal supplement use. Next, the donor must have blood testing (at the Milk Bank’s expense) – a process similar to lab screening for blood bank donation, which includes testing for HIV1&2, HTLV 1&2, Hepatitis B and C and syphilis. The screening process is very strict and an average of 35 percent of donors are consequently declined. Milk donors are volunteers and receive no compensation for their milk donation.
The milk is then collected at a milk collection site (depot) and is transported frozen on dry ice to the milk bank. Once the donated milk reaches the milk bank, it is carefully logged in with a donor identification number and then thawed and pooled with at least 3 other donors. This process creates a homogenized donor milk pool that includes a variety of human milk oligosaccharides and other bioactive human milk components.
The milk is pasteurized by heat treatment (Holder method) at 62.5 degrees Celsius for 30 minutes and then frozen at -18 degrees Celsius. The pasteurized milk is then tested for contamination post-pasteurization and, if any infectious growth is present, the entire batch is discarded. This pasteurization protocol destroys viruses (HIV, CMV and others) and most bacteria except for bacillus cereus-which is tested for post pasteurization. The heat treatment needs to be effective in removing pathogens but gentle enough to maintain the immune and bioactive beneficial properties of human milk. This process ensures a safe high quality donor human milk supply for use in hospitals and for outpatients.
It is always important to have comprehensive lactation support available for mothers and babies whenever donor milk is used, in order to help mothers establish their own milk supply. Mothers need guidance with breastfeeding and milk expression in the hospital and after discharge while using donor milk supplementation.
Effect of pasteurization on Human Milk Quality
While pasteurization eliminates all the cellular components of breastmilk, many bioactive properties are preserved. Donor milk that is heat-treated retains important components including HMOs (human milk oligosaccharides). These complex sugars resist digestion and are the third most abundant component in human milk. There are more than 150 different HMOs and they appear to have a role as immune cell response modulators. They also promote beneficial gut bacteria, and are protective against infection due to their anti-adhesive and antimicrobial effects. HMOs and other bioactive components in human milk, are likely responsible for the significant (up to 77 percent) reduction in necrotizing enterocolitis (NEC) in premature infants.
In addition, secretory IgA retains 40- 60 percent activity after pasteurization and the iron transport protein lactoferrin and lysozyme activity are only partially reduced (50 percent). Pasteurized human milk retains the majority ( > 90 percent) of micronutrients such as calcium, copper, magnesium and zinc. Macronutrients including protein, total fat and vitamins are also retained at partial levels.
A Minnesota Milk Bank is Coming!
In 1985, the non-profit Human Milk Banking Association of North America (HMBANA) was established to create standards for all North American milk banks. HMBANA currently has 24 affiliated milk banks in the U.S.
Minnesota will open its own HMBANA affiliated Milk Bank, The MN Milk Bank for Babies, in the fall of 2018 and it will be located in the Twin Cities. The non-profit milk bank will be certified by the MN Department of Agriculture and registered with the FDA. The MN Milk Bank will provide pasteurized donor human milk statewide to hospitals and families wanting to purchase milk. Priority will be given to babies in Minnesota, expanding to out-of-state service as the milk bank grows.
To help reduce health care disparity, there is ongoing work to establish universal reimbursement by Medical Assistance and private insurance to cover the cost of banked donor milk when medically necessary (as exists now in 6 other states). Then all infants in Minnesota will have access to safe donor milk when needed for inpatient and outpatient use without restrictions.
Educational videos for families about Donor Milk – English and Spanish
From: Human Milk Initiative, NeoQIC, Massachusetts
Donor Milk Toolkit for Hospitals
From: Minnesota Breastfeeding Coalition
Pasteurized Human Milk Handout
Human Milk Banking Association of North America (HMBANA)