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A Consensus Statement from the European Milk Bank Association (EMBA)

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A Consensus Statement from the European Milk Bank Association (EMBA) REVIEW published: 04 March 2019 doi: 10.3389/fped.2019.00053 Recommendations for the Establishment and Operation of Human Milk Banks in Europe: A Consensus Statement From the European Milk Bank Association (EMBA) Gillian Weaver 1*, Enrico Bertino 2, Corinna Gebauer 3, Anne Grovslien 4, Radmila Mileusnic-Milenovic 5, Sertac Arslanoglu 6, Debbie Barnett 7, Clair-Yves Boquien 8, Rachel Buffin 9, Antoni Gaya 10, Guido E. Moro 11, Aleksandra Wesolowska 12,13 and Jean-Charles Picaud 9,14 1 Human Milk Foundation, Harpenden, United Kingdom, 2 Neonatal Unit of Turin University, City of Health and Science of Turin, Turin, Italy, 3 Abteilung Neonatologie Klinik und Poliklinik für Kinder und Jugendliche, Leipzig, Germany, 4 Neonatal Unit, Milk Bank, Oslo University Hospital, Oslo, Norway, 5 First Serbian Milk Bank, Institute of Neonatology, Belgrade, Serbia, Edited by: 6 Division of Neonatology, Department of Pediatrics, Istanbul Medeniyet University, Istanbul, Turkey, 7 Greater Glasgow and Christoph Bührer, Clyde Donor Milk Bank, Royal Hospital for Sick Children, Glasgow, United Kingdom, 8 PhAN, Institut National de la Recherche Charité Medical University of Berlin, Agronomique (INRA), Université de Nantes, CRNH-Ouest, Nantes, France, 9 Neonatal Intensive Care Unit, Hopital de la Germany Croix-Rousse, Hospices Civils de Lyon, Lyon, France, 10 Banc de Teixit, F. Banc de Sang i Teixits de les Illes Balears, Institut Reviewed by: d’Investigacio Sanitaria Illes Balears (IdISBa), Barcelona, Spain, 11 Italian Association of Human Milk Banks (AIBLUD), Milan, 12 13 Fernando Cabañas, Italy, Department of Neonatology, Faculty of Health Science, Medical University of Warsaw, Warsaw, Poland, Laboratory 14 Hospital Universitario Quirónsalud of Human Milk and Lactation Research, Holy Family Hospital Regional Human Milk Bank, Warsaw, Poland, CarMeN Unit, Madrid, Spain INSERM U1060, INRA U1397, Claude Bernard University Lyon 1, Pierre Bénite, France María Gormaz, Agencia Valenciana de Salud, Spain Objectives: To develop recommendations from the European Milk Bank Association *Correspondence: Gillian Weaver (EMBA) for the establishment and operation of human milk banks (HMB) in Europe. [email protected] 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 Specialty section: This article was submitted to guideline development and/or milk banking operations. An initial survey was agreed using Neonatology, collated published global recommendations. A total of 108 potential recommendations a section of the journal Frontiers in Pediatrics were included in the survey; responders noted which were included in their national Received: 31 August 2018 guidelines. The responses were collated, compared, and discussed and the group Accepted: 08 February 2019 determined where there was consensus and where substantial or minor differences Published: 04 March 2019 were identified. Where there was consensus or robust published evidence on which Citation: to base recommendations these were included. When there was no consensus and Weaver G, Bertino E, Gebauer C, Grovslien A, Mileusnic-Milenovic R, no clear evidence base, a statement of explanation based on collective expert opinion Arslanoglu S, Barnett D, Boquien C-Y, was agreed. Buffin R, Gaya A, Moro GE, Wesolowska A and Picaud J-C (2019) Results: Published, internationally available guidelines with recommendations for Recommendations for the human milk banks from France, Italy, and the UK, together with guidelines from Austria, Establishment and Operation of Human Milk Banks in Europe: A Denmark, Germany, Norway, Slovakia, Spain, Sweden, and Switzerland were included Consensus Statement From the as source materials. These covered: General recommendations; Donor recruitment and European Milk Bank Association (EMBA). Front. Pediatr. 7:53. screening; Expression, handling, and storage of donor human milk (DHM); Pooling of doi: 10.3389/fped.2019.00053 DHM; Milk screening; Milk treatment (pasteurization); Delivery of DHM to recipients. Frontiers in Pediatrics | www.frontiersin.org 1 March 2019 | Volume 7 | Article 53 Weaver et al. EMBA Recommendations for HMBs 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). Keywords: donor human milk (DHM), Human Milk Bank (HMB), breastfeeding, pasteurization, donor screening, bacteriology testing BACKGROUND The EMBA is a non-profit organization that was established to promote milk banking and to encourage international co- Human milk (HM) is the preferred nutrition for preterm infants operation between the HMBs of the countries of Europe as (1), but not all mothers are able to provide their child with well as globally. The association’s headquarters are in Milan, enough milk. There are specific beneficial effects of breastfeeding Italy but association meetings and conferences are held in in these infants as HM feeding reduces the risk of short term different locations within Europe. The primary aim of the EMBA and long term complications related to prematurity. Donor is to support and promote exclusive breastfeeding, which is HM (DHM) can supplement the supply of maternal breastmilk universally acknowledged to be the optimal method of feeding when it is insufficient or provide the preferred alternative when all infants. The use of DHM from HMBs for preterm and sick the mother is not breastfeeding. DHM is beneficial for the infants temporarily without access to their own mother’s milk has health of preterm infants, first because significant properties been widely shown to be linked to increased rates of exclusive are preserved following holder pasteurization (2) and secondly breastfeeding on discharge from neonatal units (10, 11). because it prevents feeding these infants with a preterm formula. The EMBA was also established to support human milk According to the World Health Organization (1) the American banking in Europe by promoting safe practices and fostering Academy of Pediatrics (3) and the European Society of Pediatric sustainable operations. Hence a further aim of the association, Gastroenterology, Hepatology, and Nutrition (4) the feeding of as listed in the EMBA Constitution1 is to “Prepare international preterm infants with mother’s own milk is recommended as the and regularly revised guidelines to set standards for the practice first choice and if this is not available pasteurized DHM from an of milk banking.” The usual methodology for establishing established milk bank should be the next alternative. guidelines is to convene appropriate multidisciplinary expertise, The main benefits for preterm infants that receive DHM consider all of the stages of a process and conduct a review of the instead of formula are faster gastric emptying, faster attainment evidence before making recommendations linked to the strength of full enteral feedings, improved gut growth and maturation, of the evidence. In the absence of such a published guideline, decreased risk of necrotizing enterocolitis and late onset sepsis, aimed at milk banks throughout Europe, it is expected that the improved neurodevelopmental outcomes, less retinopathy of development of Europe-wide recommendations by EMBA for prematurity and improved visual development (5–9). HMBs will promote best practice, optimize quality, and safety HMBs have existed since 1909 in Europe and countries within the HMBs that are currently operational as well as offer that supported the development of a significant number of valuable assistance to those who are establishing a new HMB. HMBs developed national guidelines to harmonize practices. Evidence and expert opinion based recommendations should be The European Milk Bank Association1 (EMBA) was officially the standard throughout Europe to promote consistent practices launched in October 2010. According to the definitions agreed both within and between countries. by the EMBA Board of Directors: There are currently 226 HMBs operating in 28 countries in • Human milk banks (HMB) collect, screen, store, process, and Europe. These include the first milk banks in Estonia, Lithuania, distribute DHM. Poland, Portugal, and Russia. A further 16 HMBs are planned. • The current status of HMBs in Europe is maintained on the DHM is breastmilk that has been expressed by a mother 1 and provided freely to a HMB to be fed to another EMBA website . mother’s child. The 226 HMBs in Europe incorporate newly established organizations with a limited history of operational expertise as The EMBA constitution is available to view on the EMBA well as ones that have links to the very early milk banks founded website1. The Association welcomes membership from HMBs, over a century ago. They include national and regionalized milk bank associations and individuals who support the aims services as well as small operations serving a single neonatal of the Association. Membership affords the opportunity to unit. The volumes of DHM that are tested and processed and access conference presentations from the past 6 years as provided mainly to sick and preterm infants vary widely from well as additional materials of interest
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