Recommendations for the Establishment and Operation of Human Milk Banks in Europe: A Consensus Statement From the European Milk Bank Association (EMBA)

Abstract

Objectives: To develop recommendations from the European Milk Bank Association (EMBA) for the establishment and operation of human milk banks (HMB) in Europe. Method: A working group comprising members of the EMBA was convened in 2015 to develop Europe-wide recommendations for milk banks. Each member had experience of guideline development and/or milk banking operations. An initial survey was agreed using collated published global recommendations. A total of 108 potential recommendations were included in the survey; responders noted which were included in their national guidelines. The responses were collated, compared, and discussed and the group determined where there was consensus and where substantial or minor differences were identified. Where there was consensus or robust published evidence on which to base recommendations these were included. When there was no consensus and no clear evidence base, a statement of explanation based on collective expert opinion was agreed. Results: Published, internationally available guidelines with recommendations for human milk banks from France, Italy, and the UK, together with guidelines from Austria, Denmark, Germany, Norway, Slovakia, Spain, Sweden, and Switzerland were included as source materials. These covered: General recommendations; Donor recruitment and screening; Expression, handling, and storage of donor human milk (DHM); Pooling of DHM; Milk screening; Milk treatment (pasteurization); Delivery of DHM to recipients. Conclusions: Evidence based recommendations and consensus statements from the EMBA will now be published on the EMBA website to assist in the safe establishment and operation of HMBs throughout Europe. These have also been used to inform the chapter on human milk to be included in the 2019 edition of the Guide to the quality and safety of tissues and cells for human application , published by the European Directorate for the Quality of Medicines & HealthCare (EDQM).

The Effect of Prolonged Freezing and Holder Pasteurization on the Macronutrient and Bioactive Protein Compositions of Human Milk

“…Donor milk is usually pasteurized, then frozen and stored as such until the time of use. [7][8][9][10] Holder pasteurization (heating at 62.5°C for 30 minutes) is the most commonly used method in human donor milk banks. After treatment, donor milk is a completely safe food for infants, but it is not equivalent to fresh human milk because pasteurization destroys not only pathogenic bacteria and viruses but also almost the whole microbiota of human milk.…”

Human Milk’s Hidden Gift: Implications of the Milk Microbiome for Preterm Infants’ Health

“…When MOM is unavailable or insufficient, the latest recommendations identify DHM, provided by a qualified HM bank, as the optimal alternative or supplement to MOM [74]. In order to inactivate viral and bacterial agents, current international guidelines recommend HM pasteurization using the Holder method [75], which guarantees DHM microbiological safety but is also known to impair several nutritional and biological HM properties [76,77]. Furthermore, it is likely that pasteurization, while inactivating potentially harmful microorganisms, might interfere with the resident HMM, thus impairing the probiotic effect of MOM.…”

The costs of human donor milk

“…More than a quarter of the marginal costs of donor milk resulted from microbiological examinations, triggered by efforts to feed unpasteurised milk. There is no consensus for recommendations for the microbiological testing of donor milk . Risks and benefits of feeding unpasteurised human donor milk are unknown, as almost all (11/12) randomised controlled trials comparing donor milk with formula employed pasteurisation .…”

“…Risks and benefits of feeding unpasteurised human donor milk are unknown, as almost all (11/12) randomised controlled trials comparing donor milk with formula employed pasteurisation . Pasteurisation of donor milk, as advocated by the European Milk Bank Association, not only blocks viral and bacterial pathogen transmissions but apparently also saves money. Scrutinising operational sequences for procedures without proven added value is becoming an increasingly important task to reduce their financial burden.…”