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As the number of human milk banks grows globally, the lack of international standards becomes increasingly apparent. Donated human milk is provided to the most vulnerable sick and preterm infants in order to reduce their mortality. However, this comes with a responsibility to ensure the safe and hygienic handling of milk. A systematic review analysed the best practices for each step of the milk donation process using eight country guidelines and three organisation guidelines. The result is a set of quality assuring requirements, operational recommendations, and ethical considerations that promote the development of internationally established guidelines.

The best way to nourish a newborn baby is to feed them with their mother’s own milk. However, this option is not always available for every newborn, making donor human milk an important substitute and alternative to formula feeding. A recent study conducted by researchers at the Shanghai Children’s Hospital revealed that the use of donor milk instead of formula feeding reduces of the time infants stay at the hospital by seven days and increases the weight at discharge. In addition, newborns fed with donor milk were significantly less likely to develop neonatal necrotising enterocolitis, retinopathy of prematurity, or sepsis. Most recipients of donor milk are infants born preterm or with low birth weight (LBW).

Figure 1: Human Milk Banks in Europe

Since the first milk bank was opened more than 100 years ago, the number of milk banks has grown exponentially. However there are discrepancies in how milk banks are operated, and the development in low- and middle-income countries in particular is insufficient.

To provide a clearer picture on how milk banks should be organised, the guidelines from Australia, Brazil, France, India, Italy, Spain, Switzerland, the United Kingdom, and three international milk bank associations were evaluated for best practice suggestions. The aim is to establish internationally agreed upon guidelines for milk banks that enable quality control of the facilities and can be easily adapted and implemented in each country.

The process of donated human milk from donation to feeding a preterm/LBW infant

1) Choosing the donor

Milk donation is voluntary and usually unpaid, and the donating mothers must be selected carefully. A screening interview is conducted in which the donor’s health, medication, and lifestyle are evaluated. A potential donor is excluded if she smokes, drinks more alcohol than recommended, or has certain illnesses. An informed consent must be signed before donating the milk.

2) The milk donation

Milk may be extracted from the breast by manual expression or with a breast pump. As the concentration of nutrients and fat differs between the beginning and end of a feed, it is important to collect milk from a full breast. No drip milk is used for donation and pumps must always be clean to rule out contamination.

Figure 2: Storage of donated milk

3) Handling of the milk

Only special containers are suitable for storing milk to prevent contamination, as the nutrient composition of the milk is affected by the type of container. When collecting milk at home, the milk must be labelled with two identifiers of the donor, e.g. an ID and their date of birth. A barcode system is recommended for collection at the hospital. In addition, the temperature of the milk during transport and storage is of crucial importance. The sooner the donated milk is frozen, the better. Depending on the temperature, the milk can be stored for several months. Quality is ensured through the establishment of optimal procedures, staff training, equipment maintenance, standardised protocols, and reliable record keeping.

4) Processing the milk

As breast milk is not sterile, its safety must be ensured. First, any milk with bacterial growth is excluded by bacteriological screening before heat treatment (pasteurisation) is carried out. The most commonly used technique is Holder pasteurisation where milk is heated up to 62.5°C for 30 min. Other pasteurisation methods are also used; however, they show a greater reduction of nutrients or immune modulating molecules. The same reduction of nutrients occurs when a container change takes place. It should therefore be limited to a minimum.

Including ethical considerations in the call for international guidelines

Figure 3: Beneficiaries of human donor milk

There is great ethic complexity around the issue of milk banks, discussing the priorisation of infants, with preterm sick infants having the highest priority, as this approach saves the most lives. In addition, healthcare professionals need to have an understanding of Jewish and Muslim perspective on milk donation, as religious women may have concerns. Adequate counselling should be provided for those families.

In order to ensure an ethically, high quality handling of donor human milk, these recommendations ought to be defined as international guidelines for milk banks to ensure the best support and nutrition for sick and preterm infants.

Paper available at: https://onlinelibrary.wiley.com/doi/10.1111/mcn.13657

Ful list of authors: Sharon L. Unger and Deborah L. O’Connor

DOI: https://doi.org/10.1111/mcn.13657

More information from EFCNI is available here and here and from the European Milk Bank Association here