A comparative review of human milk banking and national tissue banking programs.

This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first-choice supplement to a mother's own milk both within and beyond preterm, low-birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO-inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.

Donation barriers, enablers, patterns and predictors of milk bank donors in the United States and United Kingdom.

Pasteurised donor human milk is recommended for very low birthweight infants who do not have access to their mother's milk. Although the use of donor milk continues to increase, little is known about the donation experiences of milk bank donors. We aimed to describe and compare enablers, barriers and patterns of human milk donation and identify factors predicting donation volume in a convenience sample of approved milk bank donors in the United Kingdom and the United States. A cross-sectional online survey was conducted from August 2022 to December 2022. Approved milk bank donors (n = 556) from three milk banks in the United States (n = 369, Mothers' Milk Bank of Florida, Mother's Milk Bank of North Texas and Northwest Mothers Milk Bank) and one milk bank in the United Kingdom (n = 187, Hearts Milk Bank) completed the survey. A substantial portion of donors in both settings reported participating in other forms of milk exchange (51% of U.S. donors vs. 39% of UK donors, p = 0.009). Top donation barriers reported in both settings were completing the serological screening and having enough space to store collected milk. Most donors started donating when their infant was 3 months old or older and reported donating mature milk. The most common source of information related to milk banking in each setting was the internet (United Kingdom-70% vs. United States - 63%, p = 0.112). Variables that predicted lifetime donation volume differed between the United States and the United Kingdom, highlighting the importance of setting-specific milk banking research.

International expert meeting on the donation and use of human milk: Brief report.

Where a mother's own milk is not available or is insufficient, donor human milk (DHM) processed by a human milk bank (HMB) is the recommended next best alternative. HMBs exist in over 65 countries. However, most countries have yet to establish national policies or programmes that support the provision of DHM. In July 2019, a group of international experts in fields relevant to human milk banking gathered at a meeting organised by the Institute of Biomedical Ethics, University of Zurich, and co-sponsored by the World Health Organisation. Prompted by the growing interest globally in creating and sustaining HMBs and addressing current safety and ethical concerns and standards, the aims of the meeting were to define knowledge gaps, determine the need for and scope of global guidelines and provide recommendations on steps that need to be taken at the international level. Following wide-ranging discussions that included the integration of milk banks into health care systems, strategy and policy, quality and safety, the use of DHM and associated ethical considerations, the overall conclusion of the meeting was that in the absence of global recommendations on the implementation, operation and regulation of HMBs, evidence-based guidance is urgently needed.

Vegan/vegetarian diet and human milk donation: An EMBA survey across European milk banks.

The nutritional adequacy of human milk (HM) from vegan/vegetarian mothers has been a matter of debate, and a variety of recommendations regarding the eligibility of these mothers as human milk donors exists. According to the latest evidence, HM from vegans/vegetarians is similar in its composition to that from omnivores, however, some differences may be observed regarding vitamin B12 and omega-3 fatty acids concentrations. Maternal supplementation of these compounds has been proven effective in increasing their HM concentration. With this survey, we aimed to explore the practices currently in use in European human milk banks (HMBs) regarding potential donors following vegan/vegetarian diets. The online survey was distributed to European HMBs between January and July 2022. A total of 188 HMBs were contacted, and 118 replied (response rate 63%). Vegan and vegetarian mothers were recommended supplements of vitamin B12 to be accepted as donors in 27% and 26% of HMBs, respectively. Additional omega-3 fatty acid supplementation was required in 8% HMBs. In the remaining HMBs, these mothers were either systematically excluded or included regardless of supplementation. The dosage of the recommended supplements was extremely variable. Fifty-one percent of HMBs were following recommendations to guide their practice, national or local recommendations mainly. Great variability in European HMBs practices towards potential donors following vegan/vegetarian diets exists. Some of these practices can result in loss of donors and/or in potential nutritional deficiencies. Standardised evidence-based recommendations on this issue and their implementation in daily HMB practice are needed.

Comparison between the for-profit human milk industry and nonprofit human milk banking: Time for regulation?

Human milk (HM) is a highly evolutionary selected, complex biofluid, which provides tailored nutrition, immune system support and developmental cues that are unique to each maternal-infant dyad. In the absence of maternal milk, the World Health Organisation recommends vulnerable infants should be fed with screened donor HM (DHM) from a HM bank (HMB) ideally embedded in local or regional lactation support services. However, demand for HM products has arisen from an increasing awareness of the developmental and health impacts of the early introduction of formula and a lack of prioritisation into government-funded and nonprofit milk banking and innovation. This survey of global nonprofit milk bank leaders aimed to outline the trends, commonalities and differences between nonprofit and for-profit HM banking, examine strategies regarding the marketing and placement of products to hospital and public customers and outline the key social, ethical and human rights concerns. The survey captured information from 59 milk bank leaders in 30 countries from every populated continent. In total, five companies are currently trading HM products with several early-stage private milk companies (PMCs). Products tended to be more expensive from PMC than HMB, milk providers were financially remunerated and lactation support for milk providers and recipients was not a core function of PMCs. Current regulatory frameworks for HM vary widely, with the majority of countries lacking any framework, and most others placing HM within food legislation, which does not include the support and care of milk donors and recipient prioritisation. Regulation as a Medical Product of Human Origin was only in place to prevent the sale of HM in four countries; export and import of HM was banned in two countries. This paper discusses the safety and ethical concerns raised by the commodification of HM and the opportunities policymakers have globally and country-level to limit the potential for exploitation and the undermining of breastfeeding.

Characteristics and factors influencing the volume of breastmilk donated by women to the first human milk bank in Vietnam.

Background: Donor human milk (DHM) is essential to the operation of human milk banks (HMB). This study examined characteristics and factors associated with higher volumes of DHM donation at the first HMB in Vietnam. Method: Data from an online HMB monitoring system collected between February 2017 and July 2022 included demographic characteristics, child information, the timing of donation, and the volume of DHM. Higher volume is defined as equal to or greater than the median DHM volume per donor of 14.4 liters (L). Potential contributors to higher DHM volume were examined using the chi-square test in univariate and multivariable logistic regression analysis. Results: During the 5.5-year operation, this HMB recruited 517 donors with an average age of 28.6 years. Approximately 60.9% of donors had a college or higher degree and 97.3% gave birth in Da Nang city. Of these donors, the prevalence of cesarean birth was 48.2%, preterm births was 40.2%, and 27.9% had babies with a birth weight of less than 1,500 g. There was a similar proportion of donors between the hospital (48.2%) and community (51.8%). On average, hospital donors started their donations 15 days after birth when their newborns were 33.9 weeks corrected age compared to 63 days and 47.7 weeks among community-based donors. The overall median volume of DHM per donor was 14.4 L over a period of 46 days. The amount and duration were higher in community-based donors (17.5 L in 72 days, 300 ml/day) than those in the hospital (8.4 L in 30 days, 258 ml/day). More than 37% of donors contacted the HMB themselves; the remainder were introduced by health professionals. Factors associated with higher volumes of DHM included higher education (OR: 1.77; 95% CI: 1.09, 2.87), having a full-term newborn (OR: 2.46; 95% CI: 1.46, 4.13), and community-based donors (OR: 2.15; 95% CI: 1.22, 3.78). Conclusions: Mothers with higher education and from the community donate more breastmilk over a longer duration than those with lower education and from the hospital. Breastfeeding protection, promotion, and support should be offered to all mothers with specialized breastfeeding support for mothers of preterm and sick infants. This will ensure mothers have sufficient breastmilk for their newborns and potentially surplus breastmilk for donation.

Comparison of Breastfeeding and Pumping Experiences of Milk Bank Donors in the United States and United Kingdom.

Background/Objective: As human milk banking services expand, information about lifestyle characteristics and infant feeding experiences of milk bank donors is relatively limited. Our goal was to describe and compare milk bank donors' demographic, clinical, and lifestyle characteristics, and breastfeeding experiences in a variety of geographic settings. Methods: A cross-sectional online survey was conducted from August 2022 to December 2022 with approved donors from three milk banks in the United States (n = 369), and one milk bank in United Kingdom (n = 187). Results: Donors in all settings were predominantly in their early 30s, White, married, educated, and identified as female. U.K. donors reported more frequently being on maternity leave (33% versus 5%, p < 0.001), predominantly feeding directly at the breast in the first 3 months postpartum (51% versus 28%, p < 0.001), and breastfeeding a single child longer (21.2 versus 13.3 months, p < 0.001) than U.S. donors. Significantly more U.S. donors reported pumping due to work (34% versus 11%, p < 0.001) and pumping multiple times per day (57% versus 36%, p < 0.001). Most donors reported receiving information about breastfeeding from a health care provider (94% United States and 88% United Kingdom, p = 0.022), while the internet was the most popular source of information about pumping (65% United States and 64% United Kingdom, p = 0.751). Conclusion: Factors not directly related to milk banking (e.g., maternity leave, sources of breastfeeding/pumping assistance) may have an impact on how donors feed their children and ultimately on their milk donation pattern. The impact of donor characteristics and feeding practices on donation patterns warrants further investigation.

Understanding the current and future usage of donor human milk in hospitals: An online survey of UK neonatal units.

The use of donor human milk (DHM) where there is a shortfall of maternal milk can benefit both infant and maternal outcomes but DHM supply is not always assured. This study aimed to understand current DHM usage in UK neonatal units and potential future demand to inform service planning. An online survey was disseminated to all UK neonatal units using Smart Survey or by telephone between February and April 2022 after development alongside neonatal unit teams. Surveys were completed by 55.4% of units (108/195) from all 13 Operational Delivery Networks. Only four units reported not using DHM, and another two units only if infants are transferred on DHM feeds. There was marked diversity in DHM implementation and usage and unit protocols varied greatly. Five of six units with their own milk bank had needed to source milk from an external milk bank in the last year. Ninety units (84.9%) considered DHM was sometimes (n = 35) or always (n = 55) supportive of maternal breastfeeding, and three units (2.9%) responded that DHM was rarely supportive of breastfeeding. Usage was predicted to increase by 37 units (34.9%), and this drive was principally a result of parental preference, clinical trials and improved evidence. These findings support the assumption that UK hospital DHM demand will increase after updated recommendations from the World Health Organization (WHO) and the British Association of Perinatal Medicine. These data will assist service delivery planning, underpinned by an ongoing programme of implementation science and training development, to ensure future equity of access to DHM nationally.

Differences in the Microbiological Profile of Raw and Pasteurized Breastmilk from Hospital and Community-Based Donors at the First Human Milk Bank in Vietnam.

Background: Microbiological quality is one of the key safety standards in human milk bank (HMB) operations. We describe the profiles of bacteria in donor human milk (DHM) before and after the pasteurization of samples collected from breastfeeding women in the hospital and from the community in the first HMB in Vietnam. Methods: Data were collected between February 2017 and January 2022 from an online HMB monitoring system. First, DHM samples were cultured, and the number of colony-forming units (CFU) were counted before (n = 708) and after pasteurization (n = 1146). The gram-staining method combined with the Vitek 2 Compact system were used to identify types of organisms at the Da Nang Hospital for Women and Children's Laboratory. Passing criteria for DHM included pre-pasteurization samples had a total colony count <105 CFU/mL and post-pasteurization was <10 CFU/mL. Results: During five years of operation, Da Nang HMB had 491 donors (48.7% were hospital and the rest community donors) who donated an average amount of 14.2 L over 45 days. Of this DHM volume, 84.9% of donor samples passed the pre- and post-pasteurization microbiological tests. DHM from community donors had a higher pass rate (87.8%) compared to that from hospital donors (79.5%). Before pasteurization, 15.4% of DHM samples had a bacteria count <103 CFU/mL, 63.0% had 103-<105 CFU/mL, and 21.6% had ≥105 CFU/mL. Most of the unpasteurized DHM samples (93.0%) had microorganism growth: with one organism (16.4%), two (33.9%), three or more (43.6%). After pasteurization, 17.9% samples had a bacteria count of 1−9 CFU/mL and 7.2% had ≥10 CFU/mL. DHM samples from community donors had a lower bacterial count and number of organisms than those from hospital donors both before and after pasteurization. The highest microorganisms from unpasteurized DHM samples were Staphylococcus epidermidis (74.2%), Acinetobacter sp. (52.1%), gram-positive bacillus (51.7%), Staphylococcus coagulase-negative (15.8%), and Staphylococcus aureus (10.5%). Common microorganisms from pasteurized DHM were gram-positive bacillus (21.0%), Staphylococcus epidermidis (3.9%), and Acinetobacter sp. (0.9%). Samples from the hospital tended to have a higher contamination with those microorganisms than those from community donors. Conclusions: The majority of DHM samples in Da Nang passed microbiological testing criteria. DHM from community donors had higher pass rates than hospital donors. Corrective actions are needed to improve HMB operations and hospital microbiological quality standards, as well as general improvements in water and sanitation.

Setting up the first human milk bank in Uganda: a success story from Nsambya hospital.

Background: The World Health Organization (WHO) strongly recommends the use of donor human milk (DHM) for low birth weight infants when mother's own milk is unavailable or insufficient. However, the use of DHM requires the availability of human milk banks (HMBs), the majority of which are in middle and high-income countries. Developing countries offer multiple opportunities and challenges regarding the establishment and operationalization of HMBs. This study describes the experience in setting up the HMB in Uganda at St. Francis Hospital Nsambya. Methods: The establishment of the first HMB in Uganda followed a step-wise approach using the PATH's Resource Toolkit for Establishing and Integrating Human Milk Banks. The steps included: performing a facility readiness assessment, implementing quality control measures, forming and training a committee for the Baby Friendly Hospital Initiative, establishing a monitoring and evaluation system, developing a communication strategy, engaging with the Ministry of Health, providing staff training by a Human Milk Bank consultant, and maintaining regular coordination by a dedicated technical team. Results: A total of 170 donors have been screened and of these 140 have donated milk with a mean age of 26 years since the establishment of the bank in November 2021. A total of 108 admitted neonates have received the milk; majority (88%) are preterm infants with a mean gestational age of 34 weeks. A total of 90 liters have been collected and 76 distributed. The challenges in establishment of the Human Milk bank included: lack of guidelines on human milk banking, use of unpasteurized milk, lack of communication strategy, lack of clear model infrastructure and lactation training. We addressed the challenges: by drafting guidelines, set up a human milk bank and had training on use donor pasteurized milk, designed communication messages through videos and brochures, visited Pumwani hospital and remodeled the Human Milk Bank according to the model at Pumwani, all the health workers in the human milk bank had a training on Lactation. Assessing the experiences and attitudes of mothers, donors, healthcare providers, and hospital leaders revealed concerns about milk safety and fear about potential attachments or acquired traits through the donated milk to the babies that may receive it. Donors viewed milk donation as a life-saving act, although fears of breast cancer and lumps arose from misconceptions. To address these perspectives, creative media, such as videos and messages, were designed to raise awareness, promote behavioral change, and create demand for the HMB services. Conclusion: The establishment and integration of HMB services at hospitals in Uganda is feasible.

Establishing a novel community-focussed lactation support service: a descriptive case series.

BACKGROUND: Although breastfeeding is widely acknowledged as protecting both infant and maternal health postnatally, a partial or complete shortfall of maternal milk can occur for a range of reasons. In this eventuality, the currently available options for feeding infants are screened donor human milk (DHM), infant formula or unscreened shared human milk. In the UK, DHM has only been widely available in specific clinical contexts for the last 40 years, mainly to reduce the risk of necrotising enterocolitis in extremely preterm infants alongside optimal support for maternal lactation and breastfeeding. The Hearts Milk Bank (HMB) was established in 2017 as an independent, non-profit human milk bank that aimed to ensure equitable, assured access to screened DHM for neonatal units. As a result of the generosity of mothers, a surplus of DHM rapidly became available and together with lactation support, has since been provided to families with a healthcare referral. This programme has now been formalised for families facing lactational challenges, and DHM stocks are permanently maintained to meet their needs. CASE SERIES: This case series describes the clinical paths of four families who accessed lactation support and DHM from the HMB, along with a description of the process for community provision. To date, the HMB has supported over 300 families. Working collaboratively with key stakeholders, the HMB team has developed a prioritisation strategy based on utilitarian ethical models, protocols that ensure safe handling and appropriateness of use, broader donor recruitment parameters that maintain safety with a pragmatic approach for full term healthy infants, and a process to ensure parents or carers have access to the knowledge needed to give informed consent and use DHM appropriately. CONCLUSIONS: Stakeholders, including parents, healthcare professionals, and milk banks, will need to discuss priorities for both DHM use and research gaps that can underpin the equitable expansion of services, in partnership with National Health Service (NHS) teams and third-sector organisations that support breastfeeding and maternal mental health.

The legislative framework of donor human milk and human milk banking in Europe.

Data about the regulatory approaches to donor human milk (DHM) in European countries are lacking. The aim of this study is to describe the various regulations of DHM within European countries, to assess its legislative context and its impact in relation to donor milk banking. We performed a cross-sectional survey using a semistructured online questionnaire addressing 29 national European milk-banking representatives from June 2020 to February 2021. Representatives of 26 national DHM services participated in this study. The legal classification and regulatory status of DHM were defined in 9 out of 26 areas of jurisdiction (35%) as either food product (n = 6), product of human origin according to a blood, tissue, cell regulation (n = 2), or medicinal product (n = 1). In the remainder, DHM remains unclassified. Most legislations did not provide a comprehensive framework concerning DHM and costs to cover milk bank operations were rarely reimbursed. In general, the lack of national legislative governance and the actual legislative regulations in place do not support the use of DHM in European countries. National medical guidelines for the use of DHM have been issued in only 11 countries. The current number and distribution of milk banks (n = 239) within participating countries may not provide an equitable access to DHM for eligible infants. These findings could guide stakeholders aiming to establish a regulatory framework for DHM.

Developing global guidance on human milk banking.

Donor human milk is recommended by the World Health Organization both for its advantageous nutritional and biological properties when mother's own milk is not available and for its recognized support for lactation and breastfeeding when used appropriately. An increasing number of human milk banks are being established around the world, especially in low- and middle-income countries, to facilitate the collection, processing and distribution of donor human milk. In contrast to other medical products of human origin, however, there are no minimum quality, safety and ethical standards for donor human milk and no coordinating global body to inform national policies. We present the key issues impeding progress in human milk banking, including the lack of clear definitions or registries of products; issues around regulation, quality and safety; and ethical concerns about commercialization and potential exploitation of women. Recognizing that progress in human milk banking is limited by a lack of comparable evidence, we recommend further research in this field to fill the knowledge gaps and provide evidence-based guidance. We also highlight the need for optimal support for mothers to provide their own breastmilk and establish breastfeeding as soon as and wherever possible after birth.

Lorsque la mère est dans l'impossibilité d'allaiter, l'Organisation mondiale de la Santé recommande d'opter pour le lait humain provenant de donneuses, tant pour ses propriétés nutritionnelles et biologiques que pour la contribution avérée qu'il apporte à la lactation et à l'allaitement quand il est utilisé à bon escient. Un nombre croissant de banques de lait humain s'établissent dans le monde entier, en particulier dans les pays à faible et moyen revenu, afin de faciliter la collecte, le traitement et la distribution de lait humain provenant de donneuses. Cependant, contrairement à d'autres produits médicaux d'origine humaine, il n'existe aucune norme minimale de qualité, de sécurité et d'éthique en la matière, et aucun organe de coordination global n'a été créé pour guider les politiques nationales. Dans le présent document, nous évoquons les principaux obstacles à la progression des banques de lait humain, notamment l'absence de définition claire ou de registre de produits; les problèmes relatifs à la réglementation, la qualité et la sécurité; ainsi que les questions éthiques entourant la commercialisation et l'exploitation potentielle des femmes. Jugeant cette progression limitée par le manque de données comparables, nous encourageons à mener d'autres recherches dans ce domaine pour combler les lacunes et fournir des orientations fondées sur des preuves. Nous soulignons également la nécessité d'offrir un soutien optimal aux mères afin qu'elles puissent produire leur propre lait et allaiter autant que possible immédiatement après la naissance.

La Organización Mundial de la Salud recomienda la leche humana donada tanto por sus ventajosas propiedades nutricionales y biológicas cuando no se dispone de la propia leche materna como por su reconocido apoyo a la lactancia y al amamantamiento cuando se utiliza de manera adecuada. Cada vez se crean más bancos de leche humana en todo el mundo, sobre todo en los países de ingresos bajos y medios, para facilitar la recogida, el procesamiento y la distribución de leche humana donada. Sin embargo, a diferencia de lo que ocurre con otros productos médicos de origen humano, no existen estándares mínimos de calidad, seguridad y ética para la leche humana donada ni un organismo mundial de coordinación que sirva de base a las políticas nacionales. En este documento se exponen los principales problemas que impiden el progreso de los bancos de leche humana, como la falta de definiciones claras o de registros de productos; los problemas relacionados con la regulación, la calidad y la seguridad; y las preocupaciones éticas sobre la comercialización y la posible explotación de las mujeres. Dado que el progreso de los bancos de leche humana se ve limitado por la falta de evidencias comparables, se recomienda seguir investigando en este campo para compensar los vacíos de conocimiento y proporcionar una guía asistencial. Asimismo, se destaca la necesidad de apoyar al máximo a las madres para que se provean de su propia leche materna y establezcan la lactancia materna tan pronto y siempre que sea posible después del nacimiento.

"Donor milk banking: Improving the future". A survey on the operation of the European donor human milk banks.

BACKGROUND: Provision of donor human milk is handled by established human milk banks that implement all required measures to ensure its safety and quality. Detailed human milk banking guidelines on a European level are currently lacking, while the information available on the actual practices followed by the European human milk banks, remains limited. The aim of this study was to collect detailed data on the actual milk banking practices across Europe with particular emphasis on the practices affecting the safety and quality of donor human milk. MATERIALS AND METHODS: A web-based questionnaire was developed by the European Milk Bank Association (EMBA) Survey Group, for distribution to the European human milk banks. The questionnaire included 35 questions covering every step from donor recruitment to provision of donor human milk to each recipient. To assess the variation in practices, all responses were then analyzed for each country individually and for all human milk banks together. RESULTS: A total of 123 human milk banks completed the questionnaire, representing 85% of the European countries that have a milk bank. Both inter- and intra-country variation was documented for most milk banking practices. The highest variability was observed in pasteurization practices, storage and milk screening, both pre- and post-pasteurization. CONCLUSION: We show that there is a wide variability in milk banking practices across Europe, including practices that could further improve the efficacy of donor human milk banking. The findings of this study could serve as a tool for a global discussion on the efficacy and development of additional evidence-based guidelines that could further improve those practices.

Trends and Dynamics in the First Four Years of Operation of the First Human Milk Bank in Vietnam.

BACKGROUND: Since 1979, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) have recommended the use of pasteurized human milk from a human milk bank (HMB) to feed low birthweight (LBW) and preterm newborns as the 'first alternative' when mothers are unable to provide their own milk. However, they have not issued any guidelines for the safe establishment and operation of an HMB. This gap contributes to the demand for gathering experiences from HMB networks, especially those from lower-middle income countries. To fill this knowledge gap, this study examines the characteristics of donors, donation, pasteurization, and recipients during the first four years of operation in the first HMB in Vietnam. METHODS: Data about the donors, donation, pasteurization, and recipients were extracted from the web-based electronic monitoring system of the HMB from 1 February 2017 to 31 January 2021. RESULTS: In the first four years of operation there were 433 donors who donated 7642 L of milk (66% from the community) with an increased trend in the amount of donated milk, donation duration, and average amount of milk donated by a donor. Approximately 98% of the donated milk was pasteurized, and 82% passed both pre- and post-pasteurization tests. Although the pass rate tended to increase with time, a few dips occurred. Of 16,235 newborns who received pasteurized donor milk, two thirds were in the postnatal wards. The main reason for the prescription of pasteurized donor milk was insufficient mothers' own milk in the first few days after birth. There was a decreased trend in the amount and duration of using pasteurized donor milk in both postnatal wards and the neonatal unit. CONCLUSIONS: The HMB has operated efficiently in the previous four years, even during the COVID-19 pandemic, to serve vulnerable newborns. Ongoing evidence-based adjustments helped to improve the operation to recruit suitable donors, to increase the access to and quality of raw donor milk, to improve the pasteurization process, and to meet the need of more newborns.

Use of donor human milk in nonhospitalized infants: An infant growth study.

When mother's own milk (MOM) is unavailable or insufficient, donor human milk (DHM) is recommended as the next best alternative for low birthweight infants. DHM use for healthy, term infants is increasing, but evidence for growth and tolerability is limited. This retrospective study evaluated growth in term infants in the community who received DHM from a UK milk bank. Mothers of infants receiving DHM between 2017 and 2019 were contacted (n = 49), and 31 (63.2%) agreed to participate. Fourteen infants received DHM as a supplement to other feeds (MOM and/or infant formula) and 17 were exclusively fed DHM where breastfeeding was impossible (range: 3-6 weeks). Growth was assessed by deriving z-scores using the WHO standard for infant growth and compared with 200 exclusively breastfed infants. Multivariate regression analysis revealed no feeding method-specific association between z-score and age, nor between weight and age, suggesting that z-scores and growth velocity were not affected by feeding exclusive MOM, supplemental DHM or exclusive DHM. DHM was well-tolerated with no adverse events that led to early cessation. After receiving supplemental DHM group, 63% of infants whose mothers had no physical barrier to breastfeeding (5/8 infants) were exclusively breastfed. This novel study reports adequate growth outcomes of healthy nonhospitalized infants receiving DHM, either as the sole milk source or supplement. Prospective studies are needed to confirm whether DHM is a suitable feeding alternative for term infants in the community, optimal durations, as well as the impact of DHM availability on breastfeeding rates and maternal mental health.

Maintaining human milk bank services throughout the COVID-19 pandemic: A global response.

If maternal milk is unavailable, the World Health Organization recommends that the first alternative should be pasteurised donor human milk (DHM). Human milk banks (HMBs) screen and recruit milk donors, and DHM principally feeds very low birth weight babies, reducing the risk of complications and supporting maternal breastfeeding where used alongside optimal lactation support. The COVID-19 pandemic has presented a range of challenges to HMBs worldwide. This study aimed to understand the impacts of the pandemic on HMB services and develop initial guidance regarding risk limitation. A Virtual Collaborative Network (VCN) comprising over 80 HMB leaders from 36 countries was formed in March 2020 and included academics and nongovernmental organisations. Individual milk banks, national networks and regional associations submitted data regarding the number of HMBs, volume of DHM produced and number of recipients in each global region. Estimates were calculated in the context of missing or incomplete data. Through open-ended questioning, the experiences of milk banks from each country in the first 2 months of the pandemic were collected and major themes identified. According to data collected from 446 individual HMBs, more than 800,000 infants receive DHM worldwide each year. Seven pandemic-related specific vulnerabilities to service provision were identified, including sufficient donors, prescreening disruption, DHM availability, logistics, communication, safe handling and contingency planning, which were highly context-dependent. The VCN now plans a formal consensus approach to the optimal response of HMBs to new pathogens using crowdsourced data, enabling the benchmarking of future strategies to support DHM access and neonatal health in future emergencies.

Fortification of Human Milk for Preterm Infants: Update and Recommendations of the European Milk Bank Association (EMBA) Working Group on Human Milk Fortification.

Evidence indicates that human milk (HM) is the best form of nutrition uniquely suited not only to term but also to preterm infants conferring health benefits in both the short and long-term. However, HM does not provide sufficient nutrition for the very low birth weight (VLBW) infant when fed at the usual feeding volumes leading to slow growth with the risk of neurocognitive impairment and other poor health outcomes such as retinopathy and bronchopulmonary dysplasia. HM should be supplemented (fortified) with the nutrients in short supply, particularly with protein, calcium, and phosphate to meet the high requirements of this group of babies. In this paper the European Milk Bank Association (EMBA) Working Group on HM Fortification discusses the existing evidence in this field, gives an overview of different fortification approaches and definitions, outlines the gaps in knowledge and gives recommendations for practice and suggestions for future research. EMBA recognizes that "Standard Fortification," which is currently the most utilized regimen in neonatal intensive care units, still falls short in supplying sufficient protein for some VLBW infants. EMBA encourages the use of "Individualized Fortification" to optimize nutrient intake. "Adjustable Fortification" and "Targeted Fortification" are 2 methods of individualized fortification. The quality and source of human milk fortifiers constitute another important topic. There is work looking at human milk derived fortifiers, but it is still too early to draw precise conclusions about their use. The pros and cons are discussed in this Commentary in addition to the evidence around use of fortifiers post discharge.

Processing of Donor Human Milk: Update and Recommendations From the European Milk Bank Association (EMBA).

Background: A mother's own milk (MOM) is the gold standard for the feeding and nutrition of preterm and full term infants. When MOM is not available or there is not enough, donor human milk (DHM) should be used. Milk delivered to Human Milk Banks (HMBs) should be pasteurized to inactivate viral and bacterial agents. Currently, a pasteurization process at 62.5°C for 30 min (Holder pasteurization, HoP) is recommended in all international HMBs guidelines. State of the art: It is known that HoP affects some of the nutritional and biological components of human milk. Studies have demonstrated that temperature cycle in HoP is not always controlled or calibrated. A better check of these parameters in the pasteurizers on the market today may contribute to an improvement of the quality of HM, still maintaining some of the negative effects of the heat treatment of human milk. So, food industry, and dairy industry in particular, are evaluating innovative methodologies alternative to HoP to better preserve the nutritional and biological properties of fresh human milk, while assuring at least the same microbiological safety of HoP. The most studied processing techniques include High-Temperature-Short-Time (HTST) pasteurization, High Pressure Processing (HPP), and Ultraviolet-C (UV-C) irradiation. HTST is a thermal process in which milk is forced between plates or pipes that are heated on the outside by hot water at a temperature of 72°C for 5-15 s. HPP is a non-thermal processing method that can be applied to solid and liquid foods. This technology inactivates pathogenic microorganisms by applying a high hydrostatic pressure (usually 300-800 MPa) during short-term treatments (<5-10 min). UV irradiation utilizes short-wavelength ultraviolet radiation in the UV-C region (200-280 nm), which is harmful to microorganisms. It is effective in destroying the nucleic acids in these organisms, so that their DNA is disrupted by UV radiation. Aim: The aim of this paper is to present the EMBA recommendations on processing of HM, based on the most recent results obtained with these new technologies. Conclusions: Although research on the most promising technologies that will represent an alternative to HoP (HTST, HPP, UV-C) in the future is progressing, it is now important to recognize that the consistency and quality assurance of the pasteurizers on the market today represent a fundamental component that was previously lacking in the Holder approach.

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

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).