Review of current best practices for human milk banking.

Mother's/parent milk is the optimal way to feed infants and when unavailable, supplemental donor human milk is preferred. A safe supply of donor human milk should be available for all low birthweight infants for whom it has been shown to reduce morbidity. Human milk banking has been in existence for more than a century, although largely shut down during the 1980s, primarily due to fears of human immunodeficiency virus transmission. With renewed security in milk banking, has come an exponential growth in human donor milk use. Guidelines for milk banking have been published in many countries including Australia, France, India, Italy, Spain, Switzerland, the United Kingdom and the nonprofit organization PATH. The European Milk Bank Association and the Human Milk Banking Association of North America have also published recommendations for milk banks throughout Europe and North America, respectively. Although there is variability among these guidelines, there is general consensus on quality control measures required to provide a supply of safe donor milk. These measures include effective donor screening, safe collection, transport and storage of milk, standardized pasteurization and bacteriological testing. Operational considerations are also critical, such as appropriate training for staff, equipment maintenance and cleaning, protocol and record keeping and inspection and accreditation. Clearly delineating these key quality control measures provides an excellent foundation for establishing international guidelines. Acceptable modifications must be established for low- and middle-income countries that do not have sufficient resources; overly burdensome guidelines may make establishing a milk bank unnecessarily prohibitive. This review presents a summary of current best practices for human milk banking.

Policy statement of enteral nutrition for preterm and very low birthweight infants.

For preterm and very low birthweight infants, the mother's own milk is the best nutrition. Based on the latest information for mothers who give birth to preterm and very low birthweight infants, medical staff should encourage and assist mothers to pump or express and provide their own milk whenever possible. If the supply of maternal milk is insufficient even though they receive adequate support, or the mother's own milk cannot be given to her infant for any reason, donor human milk should be used. Donors who donate their breast milk need to meet the Guideline of the Japan Human Milk Bank Association. Donor human milk should be provided according to the medical needs of preterm and very low birthweight infants, regardless of their family's financial status. In the future, it will be necessary to create a system to supply an exclusive human milk-based diet (EHMD), consisting of human milk with the addition of a human milk-derived human milk fortifier, to preterm and very low birthweight infants.

A Descriptive Study of the Attitudes, Perceptions, and Experiences of Human Milk Donation.

BACKGROUND: The use of pasteurized human donor milk has increased in recent years due to health benefits and rising number of infants who need pasteurized human donor milk. Little is known about milk donors' experiences or what contributes to their motivation to donate. PURPOSE: Using existing evidence and the theory of planned behavior as a guide, our purpose was to describe the personal and social aspects of mothers' milk donation to a milk bank in the Midwest United States. METHODS: A convenience sample of 50 current human milk donors enrolled in this cross-sectional descriptive study. The investigator-designed online survey consisted of open and closed questions based upon existing evidence and theory of planned behavior for assessing reasons for donation, beliefs about benefits and barriers, social support for donation, donation history, and current experiences. We used the Iowa Infant Feeding Attitude Survey to characterize general breastfeeding attitudes. Data analysis consisted of content analysis for narrative data and descriptive statistics for continuous and dichotomous variables. FINDINGS/RESULTS: Six themes represented experiences of discovering donation, reasons and motivations for donating, benefits and barriers to donation, confidence in donating, and support for donation. Practical and altruistic motivations for donation were prevalent. Confidence for donation was instilled by adequate milk supply, growth of the infant, and the milk bank process and professionalism. Support from others was universal. IMPLICATIONS FOR PRACTICE: Findings can inform education regarding human milk donation. Human milk banks may benefit from identified donation barriers to improve support for donors. IMPLICATIONS FOR RESEARCH: Findings are being used for instrument development for research regarding women's intentions and donor behavior.

Donor Breast Milk for the Preterm Infant: Your Questions Answered!

Expressed breast milk (EBM) is the gold standard of infant nutrition, but is not always available for use for preterm infants in the NICU setting. Donor breast milk (DBM) is often a preferred alternative for preterm and very low birth weight (VLBW) infants when maternal milk is not available. This article discusses the composition of DBM, reviews its advantages compared to formula, discusses challenges related to its long-term use, and identifies strategies to utilize DBM in the context of total nutritional management of preterm and VLBW infants. We will use a framework of WHO, WHAT, WHERE, WHEN, and WHY to answer the questions: who gets DBM, why use DBM, where does DBM come from, what is in DBM, and when may DBM use be challenged.

Human Milk Processing: A Systematic Review of Innovative Techniques to Ensure the Safety and Quality of Donor Milk.

Pasteurization, performed at 62.5°C for 30 minutes (holder pasteurization), is currently recommended in all international human milk banks guidelines, but it affects some human milk bioactive and nutritive components. The present systematic review is aimed at critically reviewing evidence on the suitability of human milk processing techniques other than holder pasteurization, both thermal and nonthermal, to ensure microbiological safety, and on the effects of these techniques on biologically active donor milk components. A systematic review of English and non-English articles using Medline, PubMed, Embase, SCOPUS, and CAB Abstracts, with no restriction in publication date was performed. Search terms included: human, breast, donor, or banked milk, breastmilk, breast fed, breastfed, breastfeed; HTST, Flash, High Pressure, UV, ultrasonic or nonthermal; process, pasteuris, pasteuriz. Only primary research articles published in peer-reviewed journals were included, providing or not a comparison with holder pasteurized human milk, provided that the pasteurization technique was clearly described, and not intended for domestic use. Additional studies were identified by searching bibliographies of relevant articles. Twenty-six studies were identified as being relevant. Two examined both High Pressure Processing and High-Temperature-Short-Time pasteurization; 10 only examined High Pressure Processing; 10 only examined High-Temperature-Short-Time; 2 articles examined ultraviolet irradiation; 2 articles examined (thermo-)ultrasonic processing. The results indicate that data about safety for microbiological control are still scarce for most of the novel technologies, and that consensus on processing conditions is necessary for nonthermal technologies, before any conclusions on the qualitative and nutritional advantages of these techniques can be drawn.

Human Milk Banking.

Human milk banks play an essential role by providing human milk to infants who would otherwise not be able to receive human milk. The largest group of recipients are premature infants who derive very substantial benefits from it. Human milk protects premature infants from necrotizing enterocolitis and from sepsis, two devastating medical conditions. Milk banks collect, screen, store, process, and distribute human milk. Donating women usually nurse their own infants and have a milk supply that exceeds their own infants' needs. Donor women are carefully selected and are screened for HIV-1, HIV-2, human T-cell leukemia virus 1 and 2, hepatitis B, hepatitis C, and syphilis. In the milk bank, handling, storing, processing, pooling, and bacterial screening follow standardized algorithms. Heat treatment of human milk diminishes anti-infective properties, cellular components, growth factors, and nutrients. However, the beneficial effects of donor milk remain significant and donor milk is still highly preferable in comparison to formula.

Donated breast milk stored in banks versus breast milk purchased online.

QUESTION: One of my patients asked if she could buy human milk on the Internet to feed her infant if the need arose. Is using donated breast milk from the milk bank safer than buying it online? ANSWER: The World Health Organization and the American Academy of Pediatrics recommend the use of donated breast milk as the first alternative when maternal milk is not available, but the Canadian Paediatric Society does not endorse the sharing of unprocessed human milk. Human breast milk stored in milk banks differs from donor breast milk available via the Internet owing to its rigorous donor-selection process, frequent quality assurance inspections, regulated transport process, and pasteurization in accordance with food preparation guidelines set out by the Canadian Food Inspection Agency. Most samples purchased online contain Gram-negative bacteria or have a total aerobic bacteria count of more than 10(4) colony-forming units per millilitre; they also exhibit higher mean total aerobic bacteria counts, total Gram-negative bacteria counts, coliform bacteria counts, and Staphylococcus spp counts than milk bank samples do. Growth of most bacteria species is associated with the number of days in transit, which suggests poor collection, storage, or shipping practices for milk purchased online.

Conceptualizing the Commercialization of Human Milk: A Concept Analysis.

BACKGROUND: Donor human milk is recommended when infants are unable to be fed their mother's own milk or require supplementation. For-profit companies use technologies to create human milk products for infants in the neonatal intensive care setting without consistent guidelines and regulatory frameworks in place. This commercialization of human milk is inadequately conceptualized and ill-defined. RESEARCH AIMS: The aim of this study is to conceptualize and define the commercialization of human milk and discuss the need for policy guidelines and regulations. METHOD: Using a concept analysis framework, we reviewed the literature on the commercialization of human milk, analyzed the antecedents and potential consequences of the industry, and developed a conceptual definition. The literature review resulted in 13 relevant articles. RESULTS: There has been a surge in the development and availability of human milk products for vulnerable infants developed by for-profit companies. Commercialized human milk can be defined as the packaging and sale of human milk and human milk components for financial gain. Factors contributing to the commercialization of human milk include an increased demand for human milk, and consequences include potential undermining of breastfeeding. The lack of guidelines and regulations raises concerns of equity, ethics, and safety. CONCLUSION: The industry is rapidly growing, resulting in an urgent need for consistent guidelines and regulatory frameworks. If left unaddressed, there could be potential risks for donor milk banking, the future of breastfeeding, and infant and maternal health.

Innovative application of bar coding technology to breast milk administration.

Hospitalized infants often receive expressed breast milk, either from their mother or from banked milk. Breast milk provides optimal nutrition for infants but because it is a body fluid it carries the risk of disease transmission. Therefore, administering the correct breast milk to hospitalized infants is essential. Bar coding technology, used in hospitals to prevent errors related to medication administration, can be proactively applied to prevent breast milk administration errors. Bar coding systems offer advantages over manual verification processes, including decreasing errors due to human factors and providing for automated entry of feedings in the electronic health record. However, potential barriers to successful implementation must be addressed. These barriers include equipment and training costs, increased time to perform the additional steps with bar coding, and work-arounds.

Amendment to 2010 Italian guidelines for the establishment and operation of a donor human milk bank.

The present paper is an amendment to the recent Italian Guidelines of human milk banking published in 2010. Working Group on Guidelines (Panel) of the Italian Association of Human Milk Banks (AIBLUD) states, in accordance with the European Union Comission's Amending Directive of January 2011, that the hard plastic feeding bottles used in the collection, storage and pasteurization of the human milk should be Bisphenol A (BPA) free. Until new evidence are available polycarbonate feeding bottles should not be used for collection, storage and pasteurization of human milk. The paper summarizes the former and current European Commission Directives and shows the related amending changes to the 2010 Italian Human Milk Banking Guidelines.

Improved growth of preterm infants receiving mother's own raw milk compared with pasteurized donor milk.

AIM: To determine whether growth, feeding tolerance and infectious events of preterm infants is related to the proportion of intake of mother's own raw milk (maternal milk) versus pooled pasteurized banked breast milk (donor milk). METHODS: This is a prospective observational study of 55 premature infants born less than 32 weeks of gestational age admitted to the neonatal intensive care unit at the Children's Hospital of Toulouse during two 6-month periods from 2003 to 2005. Enrolled infants were exclusively on enteral feeds with maternal milk ± donor milk. RESULTS: Mean gestational age was 28.6 weeks (SD 1.5) and mean birth weight 1105 grams (SD 282). During the time of exclusively breast milk feeds, weight gain (g/kg/day) was correlated to the proportion of maternal milk consumed (p = 0.0048, r = 0.4). Necrotizing enterocolitis was inversely correlated to the amount of maternal milk. The amount of maternal milk did not impact on infectious events. CONCLUSION: Mother's own raw milk improves weight gain compared with donor milk in preterm infants. Lactation strategies should be sought that helps mothers to increase their milk production.

[HTLV and "donating" milk]. / HTLV-1 et don de lait maternel.

In France, the screening for human T-cell leukemia/ lymphoma virus type 1 and 2 (HTLV-1 and HTLV-2) during the donation of human milk has been carried out from 1992 with the application of the circular DGS 24 November 1992. The screening for antibodies against these viruses is regulated and done systematically during every donation of milk. Breast feeding being the main mode of transmission of the HTLV-1, the last ministerial decree of 25 August 2010 has made the screening test compulsory for the anonymous donation and for the personalized donation (of a mother for her own child) from all women including those affected by the infection. The milk delivered by milk banks is pasteurized (62.5 °C for 30 minutes) before freezing at -18 °C, which inactivates the pathogens. This double means of prevention of the transmission of the HTLV-1 paradoxically seems disproportionate in the absence of any precautionary measure in the case of direct breast-feeding and the use of mother's raw milk. Indeed, in most neonatal intensive care units in maternity hospitals, unpasteurized milk is administered to the neonates without any systematic preliminary testing of the serological HTLV-1 status of the mother. An increased sensitization of the community of the obstetricians, midwives and neonatologists by the Association of the Milk Banks of France (ADLF) and the Société de pathologie exotique could address the issue of screening for HTLV-1 in "donated" milk and breast-feeding.

Human milk banks in the response to COVID-19: a statement of the regional human milk bank network for Southeast Asia and beyond.

BACKGROUND: The World Health Organization (WHO) recommendations on infant feeding in the context of COVID-19 uphold standing recommendations for breastfeeding, non-separation, and skin-to-skin contact, including the use of donor human milk when mother's own milk is not available. INSUFFICIENT GUIDANCE ON THE USE OF DONOR HUMAN MILK AND THE ROLE OF HUMAN MILK BANKS IN THE PANDEMIC RESPONSE: COVID-19 clinical management guidelines in seven countries in Southeast Asia are not aligned with WHO recommendations despite the lack of evidence of transmission through either breastmilk or breastfeeding. The use of safe donor human milk accessed through human milk banks is also insufficiently recommended, even in countries with an existing human milk bank, leading to a gap in evidence-based management of COVID-19. This highlights long-standing challenges as well as opportunities in the safe, equitable, and resilient implementation of human milk banks in the region. CONCLUSIONS: This statement reflects the expert opinion of the Regional Human Milk Bank Network for Southeast Asia and Beyond on the need to revisit national guidelines based on the best evidence for breastfeeding during the COVID-19 pandemic, to incorporate human milk bank services in national obstetric and newborn care guidelines for COVID-19 where possible, and to ensure that operations of human milk banks are adapted to meet the needs of the current pandemic and to sustain donor human milk supply in the long-term. The Network also recommends sustained engagement with the global human milk bank community.

Mothers Who Engage in Long-Term Informal Milk Sharing.

Human milk has repeatedly been shown to be the best form of infant nutrition. Many reasons may prevent a family from providing human milk to their child, leaving them to seek other options. One alternative is informal milk sharing, where individuals and families find donor milk through online communities. We present perspectives from three mothers who used informal milk sharing for at least 6 months. Common themes identified are sadness, guilt, and stigmatization of informal milk sharing. Implications for practice include providing families and practitioners with resources for learning about informal milk sharing and navigating the community safely.

Donor Human Milk for Preterm Infants: A Cost-Consequence Analysis of Alternative Preservation Methods.

OBJECTIVES: To perform cost-consequence and cost-effectiveness analyses of 2 methods of donor human milk (DHM) preservation-Holder pasteurization (HoP) and high-pressure processing (HPP)-in human milk banks in Poland. METHODS: We used the results of the LACTOTECHnology as an answer to special nutritional requirements of preterm infants (LACTOTECH) preclinical study on the impact of different preservation methods on the content of bioactive milk components. The cost analysis was performed from the hospital perspective. To estimate the Diagnosis-Related Group (DRG) tariff for enteral feeding with DHM preserved by HPP, the pricing process used by the Polish health technology assessment agency (Agencja Oceny Technologii Medycznych i Taryfikacji) was followed. One-way deterministic and probabilistic sensitivity analyses on costs and human milk component parameters were undertaken. RESULTS: HPP maintains an average of 55% more potentially beneficial DHM components than HoP, but is more expensive (€35 750 vs €5066). The DRG tariff relating to milk from human milk banks preserved by the HPP method should be about €54 (130%) higher than with HoP. The cost-effectiveness ratio ranged from €0.84 to €10.27 per 1% gain in the active compound content in a daily portion of DHM. Sensitivity analysis showed that the cost of an HPP device had the most significant impact on pascalization expenses. CONCLUSIONS: HPP is a potentially more beneficial method of DHM preservation than HoP, but it is also about 7 times more expensive. Because of high pascalization costs, the cost-effectiveness analysis based on clinically significant endpoints will play an important role in decision making regarding the implementation of HPP into clinical practice of human milk banking.

Donor milk banking and breastfeeding in Norway.

Milk banks in Norway have a long tradition of using raw milk. This is a practice the authors hope to continue as they see it as the best choice until a child's own mothers' milk production is sufficient. Not only will the premature babies benefit from having milk from the bank, but if a mother, for any reason, can not supply her baby while it's in the hospital her baby should be offered milk from a bank. In Norway, with a high breastfeeding rate this can be done at many hospitals.