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A human milk bank or breast milk bank is a service which collects, screens, processes, and dispenses by prescription human milk donated by nursing mothers who are not biologically related to the recipient infant. The optimum nutrition for newborn infants is breastfeeding, if possible, for the first year. Human milk banks offer a solution to the mothers that cannot supply their own breast milk to their child, for reasons such as a baby being at risk of getting diseases and infections from a mother with certain diseases, or when a child is hospitalized at birth due to very low birth weight (and thus at risk for conditions such as necrotizing enterocolitis), and the mother cannot provide her own milk during the extended stay for reasons such as living far from the hospital.

Human milk banks had an increase in the amount of milk collected in 2012 compared to 2007, in addition the amount of milk donated by each donor had also increased. Mothers' Milk Bank (MMB) says, this service provides mothers with an alternative to infant formula and allows the mother to give their newborn the nutrition it needs for healthy growth. The International Milk Banking Initiative (IMBI), was founded at the International HMBANA Congress in 2005. It lists 33 countries with milk bank programs. The World Health Organization (WHO) states that the first alternative to a biological mother not being able to breastfeed is the use of human milk from other sources.

The primary and by far the largest group of consumers of human breast milk are premature babies. Infants with gastrointestinal disorders or metabolic disorders may also consume this form of milk as well. Human breast milk acts as a substitute, instead of formula, when a mother cannot provide her own milk. Human breast milk can also be fed to toddlers and children with medical conditions that include but are not limited to chemotherapy for cancer and growth failure while on formula.

History
Donating breast milk can be traced back to the practice of wet nursing. The first record of regulations regarding the sharing of breastmilk are found in the Babylonian Code of Hammurabi (1800 BC). These regulations were motivated by the long held belief that infants inherit the nurse’s traits through their breast milk. By the 11th century European culture considered breastfeeding indecent, which led wet nursing to become common practice among royalty and aristocracy of Europe. The practice of wet nursing declined by the 19th century due to concerns regarding unhealthy lifestyles among nurses. Consequently, the medical community began researching the effects of alternative nutrition on neonates. Theodor Escherich of the University of Vienna conducted studies from 1902 to 1911 investigating different sources of nutrition and their effect on neonates. His studies demonstrated that breastfed neonate’s intestinal bacteria was significantly different compared to neonates fed by other means. In 1909, Escherich opened the first human milk bank. The following year, another milk bank opened in the Boston Floating Hospital, the first milk bank in the US.

The 1960’s saw a decline in milk banking because of recent advances in neonatal care and baby formula. Despite these new advancements, in 1980 the World Health Organization and the United Nations Children’s fund maintained their position that donor breast milk is the best alternative to the mother’s breast milk. The practice of milk banking declined further with the HIV epidemic. The need for stringent screening increased the cost of operating milk banks, forcing them to close doors.

Improved screening methods and standardization of procedure have made donated milk a viable alternative to mother’s breast milk. The ability to pasteurize and store breast milk for up to 8 months means milk banking could become a global enterprise.

Donor Requirements
A donor must:


 * Be healthy
 * Be in the process of lactation
 * Undertake a chest x-ray or Tyne test
 * Have a negative VDRL
 * Have no evidence of hepatitis
 * Be HIV negative

More requirements may apply. For example, the requirements in Australia can be found at: http://jhl.sagepub.com/content/2/1/20.full.pdf

Health Benefits of Human Donor Milk
There are several health benefits associated with human milk, including but not limited to the provision of key nutrients, gastrointestinal development, and protecting infants against various conditions and illnesses. For those women who are unable to breastfeed, or are unable to produce sufficient amounts of milk, for whatever reasons, human milk banks can provide the opportunity for infants to access human milk and its health benefits; however, human milk banks are not an equal replacement for a mother’s milk, and other feeding alternatives also confer their own benefits.

Nutritional Benefits
Human milk has certain unique nutritional benefits that can’t be easily recreated in infant formulas. Human milk contains many bioactive compounds and live cells which have been found to be beneficial for infant development. These developmental benefits have been largely attributed to the bioactive components found within human milk which are known to: “affect biological processes or substrates and hence have an impact on body function or condition and ultimately health”. Some well recognized bioactive components of human milk are: Secretory IgA, Lactoferrin, Lysozyme, α-Lactalbumin and Osteopontin. These bioactive compounds confer benefits ranging from neurological development to bactericidal properties. The specific concentrations and array of constituents found in human milk cannot currently be reproduced, with compounds such as Osteopontin found in formula at only 1/10th the concentration of human milk. Furthermore, ratios of different compounds and enzymes vary in breast milk from mother to mother. According to the Committee on the Evaluation of the Addition of Ingredients New to Infant Formula (2004), these unique proportions can have biological significance in situations where certain compounds are in high demand. For example, there is competition for n-3 and n-6 polyunsaturated fatty acids (PUFAs) and for receptor binding sites for elements like zinc, iron, and copper. Human milk also has the ability to compensate for highly variable fat absorption in infants. Infants are still undergoing development of certain proteins, like lipases, that help the body absorb fat. Human milk contains the protein that infants lack and compensates for the variability of fat absorption from child to child. Infant formulas use vegetable oil, which is less easily absorbed than the fats in human milk. The fats in human milk, which are animal fats and cholesterol, also make up a significant portion of the brain’s grey matter, almost 30%. Human milk also contains cholesterol factors that support development of the thyroid gland hormones and proteins that protect against illness, such as antibodies, immunoglobulins, and macrophages.

Reducing the Probability of Infectious Diseases
Human milk based diets reduce the probability of contracting various infectious diseases and life threatening illnesses, particularly for premature infants. Specifically, human milk based diets minimize the risk of bacterial meningitis, bacteremia, diarrhea, respiratory tract infection, necrotizing enterocolitis (NEC), otitis media, urinary tract infection, and late-onset sepsis in preterm infants. While these benefits are typically present in untreated breast milk, the pasteurization process donor milk undergoes has been found to reduce the immunological properties.

Managing Preterm Infants
There are also specific benefits associated with human milk when caring for premature infants. Human milk leads to stronger host defense and gastrointestinal function in premature infants. A lower risk of NEC in premature infants fed donor-milk has been found. However, some evidence supports there being no difference between donor human milk and preterm formula in terms of reducing rates of NEC in preterm infants.

Effects of Formula vs. Donor Human Milk in Premature Infants
Lower incidences of diarrhea, feeding intolerance, NEC, and withdrawals from feeding intolerance in donor-milk fed infants versus formula-fed infants have been reported.

The systematic review of electronic databases found that solely formula-fed premature infants tended to experience significantly faster early postnatal growth as compared to those fed a solely donor-milk diet. However, while the early growth was slower in donor-milk fed infants, by the age of 9 months and beyond, there appeared to be no difference in the sizes of formula-fed and donor-milk-fed infants.

Potential Allergies
Infants may experience an allergic reaction to donor milk, however, they are more likely to have a reaction to formula, as it is usually plant- or bovine-based, while donor milk is species specific.

Avoiding HIV Transmission
In some cases, there are health risks associated with breastfeeding, such as when mothers are HIV-infected since breastfeeding is a route of HIV transmission; however, denying infants breast milk as a result then denies the infants essential health benefits. Therefore, the availability of human milk banks allows for infants with HIV-infected mothers to still receive human milk and its resultant health benefits, while avoiding the risk of HIV transmission from breastfeeding.

Reducing Informal Milk Sharing
Many women who wish to provide their infants with human milk but cannot provide their own turn to the internet to purchase human milk, however human milk purchased on the internet has high bacterial growth and frequent contamination with pathogenic bacteria, due to faulty collection, storage, or shipping practices. This puts infants, particularly preterms, at risk. Donor human milk banks reduce the practice of informal milk sharing, and provides an opportunity for mothers to receive safer donor milk.

Concerns
Some concerns that surround human milk bank include:

Cost
The cost of pasteurized human milk varies from $3 to $5 per ounces depending on the organization or company processing the milk, but the cost is still very high relative to baby formulas or other substitutes. High cost of human milk is generated from costly procedures of collecting, screening, processing, and shipping not the donor milk itself.

An average baby, over the first year of their life, consume an average of 25 ounces of milk per day which amounts to 9,125 ounces of milk/formula during their first year of life. The cost of baby formula in January 2016 varied from a low of $0.08/ounce to a high of $0.31/ounce which sums up to $816.48 to $3163.86 in a year depending the brand of baby formula. If the baby was to consume human milk purchased from the human milk bank($3-$5 per ounces) over the first year of their life, the cost will be approximately $27,375 which is excessively high.

Donor milk is rarely covered by insurance. The Affordable Care Act (ACA), passed in 2010, has a mandate for breastfeeding support, including breast pumps and lactation consultants and other services but the law is vague on exactly what is covered.

Costs for Families in NICU
The neonatal intensive care unit has been linked to extremely high health-care costs, an average of about $3000 a day, and being emotionally taxing on families. In addition to that, hospitalized neonates are prone to higher risks of infection. The turn to exclusive human milk feeding in the NICU; however, has indicated alleviation in long and short-term costs as human milk has been found to enhance feeding tolerance as well as reduce the incidence of necrotizing enterocolitis, sepsis, and other infections. This ultimately contributes to the overall well-being of medically fragile infants and allows for shorter NICU stays. Though an exclusive human milk diet comes with associated fees as donor breast milk used must be processed, the fees remain modest in comparison to the costs of lengthier NICU cases.

Costs for Hospitals
Although very low birth weight (VLBW) infants only make up 1.4% of all hospital births, they are often the most expensive patients. A VLBW infant can cost a hospital a mean amount of $76,224 in fees, depending on the child’s prescribed care. Negating any complications or comorbidities, neonatal intensive care unit (NICU) babies cost the hospital a baseline amount of $40,227. These NICU infants are the most prone to developing late-onset sepsis, bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), and retinopathy of prematurity (ROP). These morbidities create economic strife in the long and short term. For example, if a child is to develops late onset sepsis, the hospital costs can skyrocket to $90,000. The difference between a NICU baby with a morbidity versus a NICU baby without a morbidity is the cost of tens of thousands of dollars. Human breast milk acts as a preventative measure for these vulnerable NICU babies. Donated human breast milk saves hospital costs because human breast milk decreases the development of morbidities more so compared to formula. For example, $540 million in medical costs is saved annually by Brazil’s human milk bank.

Costs for Milk
Milk banks tend to be donor based, non-profit organizations. Those receiving donor milk from the milk banks pay for processing and shipping of the milk. Pasteurized donor milk from milk banks like those affiliated with the Human Milk Banking Association of North America, usually cost around $4.00 to $5.00 per ounce. Some families choose to cut costs by buying donor milk online or through milk-sharing agreements, rather than ordering from a milk bank. Donor milk that has not been processed in a milk bank may not be pasteurized, however, and could carry possible health risks. For families in need of donor milk, some insurance providers cover the costs. Though it is still quite uncommon, Montana, Pennsylvania, South Carolina, and Ohio are all examples of states in which health care coverage of donor milk may be instated.

Mothers' Perception of Donor Milk and Acceptability
One potential impediment to popularization and success of human milk banks is the perception mothers’ have of the safety and acceptability of donor milk. A study was conducted in KwaZulu-Natal, South Africa, where 40 women were asked what their opinion was on donor milk before and after receiving training and education on the topic. Prior to  training, a majority of mothers felt the community would view feeding a baby donor milk as unacceptable. After receiving training courses over the first year of their infants’ lives, there was a slight decrease in mothers still believing baby donor milk would be viewed as unacceptable in their community.

The study findings were consistent with earlier studies which suggest the main concern expressed by mothers with regard to the feeding of donor breast milk to their own baby was that it would be unsafe. Interestingly, mothers who completed the training felt more comfortable feeding donor milk to their babies. The percentage of women willing to donate milk increased from 30% to 73.7%.

In addition to safety concerns, some mothers express philosophical objections to donor milk. In some cases, mothers feel more comfortable peer-to-peer sharing rather than using a milk bank because they knew their milk will not be pasteurized and who the recipient was. Other reasons that women choose to donate peer-to-peer rather than through a milk bank include: limited access to a milk bank, too complicated donating process, objection to people paying for milk, and a preference of knowing the recipient.

Concerns About the Steps to Donate and Who Might Donate
Several diseases(such as HIV and Infectious tuberculosis, etc.), medications, and pharmacologically active herbal products can be passed through breast milk, all donors must undergo several necessary steps to make sure their breast milk is in good quality and is safe for babies. Generally, the first step is to complete some paperwork about basic information, medical and lifestyle histories. Next, all donor mothers need to have a blood test and serological screenings. The serological screening tests for Hepatitis B surface antigen (HBsAg), and  Hepatitis C antibody (anti-HCV), as well as HIV 1 and 2 antibody (anti-HIV 1 and anti-HIV 2) and the Human T cell Lymphotropic Virus I and II antibodies (anti HTLV-I and anti-HTLV-II).

These steps are necessary and important but lactating mothers might think they are too complex. Additionally, lack of compensation is a deterrent to many women donating in America.

A small proportion of lactating women are likely donors: mothers who have surplus breast milk and mothers who lost their babies. Efforts to increase the number of donors include education of providers, and engagement of potential donors by using social media and news media.

Lack of Health Care
Many women experiencing difficulties breastfeeding turn to human milk banks. However, according to Ratner, “ these risks include infections that can be transmitted through breast milk, including HIV, hepatitis B and C, cytomegalovirus (CMV), group B Streptococcus (GBS), and many others.” These invisible or hidden dangers may be the risks and she argues that the stranger’s breast milk may not be a reliable sources to provide for the babies.

Maximizing Utility of Human Milk Banks Under Government Regulations and Local Environment
The support of government is vital in creating an environment that maximizes a human milk bank’s efficiency and utility. Integration of the human milk bank into a government’s national infrastructure and support services not only increases awareness of the service’s safety and benefits, but also increases potential donor numbers, supply of human milk, sustainability of milk banks, and better allocation of necessary supply ( https://path.azureedge.net/media/documents/MCHN_strengthen_hmb_frame_Jan2016.pdf

). A government’s health goals largely fit that of the goal of human milk banks, which is to decrease infant mortality and provide better nutrition for children ( https://www.nature.com/articles/jp2016198.pdf ). Successful integration cases like those in Brazil epitomize the positive effects of human milk banks on infant health. Brazil is credited with saving an estimated US$540 million annually in medical costs ( https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1766344/ ). While human milk banks are a sustainable, cost-efficient model for improvement in infant mortality and nutrition, there exist different models that can be used depending on the local environment and supplies available.

While all milk banks use the same set of guidelines for processing and pasteurizing donated human milk depending on their geographical location, the models they use to collect and distribute the milk differ depending on their local environment. Taking the models of milk banking in South Africa, we extract three basic models ( https://path.azureedge.net/media/documents/MCHN_5_milk_banking_models.pdf ):


 * 1) Hospital Model

The hospital model obtains milk from mothers within a hospital who are screened and tested for HIV. Milk is then prioritized to infants in the same hospital who are under 1500 grams or whose mothers have tested positive for HIV and are given through method of prescription by a doctor. Pasteurization occurs through commercial grade equipment in most hospitals and milk banks are situated within the neonatal unit in hospitals, run through funding from external sources ( https://path.azureedge.net/media/documents/MCHN_5_milk_banking_models.pdf ).


 * 1) Public-Private Partnership Model

The milk bank itself is run by a separate private organization who collects milk from healthy local donors. The milk is then supplied to both private and public hospitals, prioritizing infants who are below 1800 grams or younger than 14 days. The milk’s main purpose is not for nutritional purposes, but rather to prevent certain diseases like necrotizing enterocolitis. The milk bank charges the minimum fee for milk heading to public hospitals, while they ask for donations from recipients in private hospitals to help sustain their model and cause ( https://path.azureedge.net/media/documents/MCHN_5_milk_banking_models.pdf )


 * 1) Community-Based Model

The community-based model procures milk and funding from the local community using local media sources. Forth procuring the necessary milk, the milk is prioritized towards orphans and HIV-positive infants. The milk is also given for a longer period of time than the other two models (sometimes until they reach 12-18 months) to strengthen the infant’s immune system ( https://path.azureedge.net/media/documents/MCHN_5_milk_banking_models.pdf )

Brazil
Brazil has an extensive network of 217 milk banks, and is considered to have the most cost efficient system of milk banking in the world. Since the inception of the first milk bank in 1985, the infant mortality rate in Brazil has dropped 73% due, in part, to the popularization of milk banks. In 2011, 165,000 liters (5,580,000 fl oz) of breast milk were donated by some 166,000 mothers, and provided to nearly 170,000 babies. The Brazilian and Ibero-American Network of Human Milk Banks coordinates these efforts. All donors are screened: in general, they must be healthy and not be taking any medication. The Brazilian system is defined by its inexpensive pasteurization of milk and has spread to other countries such as Spain, Portugal, the Cape Verde Islands, and portions of the rest of Latin America.

Europe
There are 223 active human milk banks in 28 countries within Europe, with14 more planned as of November 2018. Currently, Italy has the most milk banks, at 37, while Turkey has the least, having no milk banks.

Norway
Norway stands out for choosing not to pasteurize donated milk. This tradition dates back to Norway’s first milk bank (founded during the World War II), and has survived for the most part to extremely rigorous screening procedures. In addition, donation centers such as the Rikshospitalet University Hospital cover any auxiliary fees that may be incurred by a donor, to avoid discouragement from donation due to an economic burden.

The country’s decision not to pasteurize milk has been long standing since the inception of its first milk bank, due to the in part to the aforementioned rigorous screening process. In addition, the pasteurization process has been found to destroy essential nutrients unique to the breast milk that aid in an infant’s development. However, Norway has a milk bank that stores pasteurized milk in the event of specific circumstances, such as an extremely premature infant, in which case there is a risk of a virus transmission through raw breast milk.

North America
Main article: Human milk banking in North America

The Human Milk Banking Association of North America (HMBANA) has a "Guidelines for the Establishment and Operation of a Donor Human Milk Bank" that establishes exhaustive guidelines for safe milk collection and usage in North America. As of 2018, there are 24 milk banks accredited by HMBANA in the United States and two in Canada. These two countries alone account for all 26 accredited milk banks in North America.

South Africa
Human Milk Banks have gained significant traction since the early 2000's in South Africa. While the practice informally began in hospitals in the 1980's, according to the Human Milk Banking Association of South Africa (HMBASA), most transfers of breast milk lacked any vetting process of mothers willing to donate their breast milk. Operations ceased upon the realization that breastmilk could spread HIV/AIDs, until modern pasteurization techniques reopened the possibility for breastmilk transfers. To inhibit a sequential propagation of infection or disease via breast milk, the HMBASA established guidelines for donor milk in 2008; and milk banks have continued to emerge in South Africa to date.

In 2011, the South African Ministry of Health backed the propagation of human milk banks as a temporary mechanism to substitute for breastfeeding. Having developed and institutionalized since 2008, human milk banks are now used in South Africa, since ongoing epidemics of AIDs and other lethal infectious diseases have reduced a substantial percentage of mothers who can provide healthy breast milk to their children.

South Africa has a breast milk collection and distribution program, Milk Matters, based in Cape Town. Milk Matters has 25 deposit sites across South Africa, according to its website. Additionally, the South African Breast Reserve, which began in 2003, has distributed over 20,000 units of breastmilk to premature babies across the country, according to its website.

Singapore
Breastfeeding in Singapore overall has developed significantly over the last 20 years. In 1997, a study on nearly 15,000 infants in Singapore found that only 6.3% of mothers breastfeed their children 4 months after birth; the number quickly escalated to 29.8% in 2001, according to a National Breastfeeding survey. Growing Up in Singapore Towards healthy Outcomes (GUSTO) finds that this number has continued to increase, as women who breastfed their children 6 months after birth had risen to approximately 39% by March, 2016.

Singapore launched a three-year pilot donor breast milk bank on Thursday 17th August 2017. It is a collaboration between KK Women’s and Children’s Hospital (KKH) and Temasek Foundation Cares. The foundation has set aside S$1.37 million (US$1 million) for the milk bank, which will collect, screen, process and store breast milk from donor mothers.

India
In 2017, the Indian Government announced an initiative to increase awareness on the benefits of breastfeeding and to improve access to breastmilk through milk banks. India currently has about 50 milk banks and is in pursuit of lowering costs while expanding outreach.

Australia
As of 2018 Australia has a total of 6 Human Milk Banks in operation:


 * PREM bank (based at King Edward Memorial Hospital, WA and also supplying Princess Margaret Hospital);
 * The Australian Red Cross Blood Service Milk Bank
 * Royal Prince Alfred (RPA) Hospital neonatal intensive care unit (NSW);
 * Mothers Milk Bank Pty Ltd (a private charity, previously located on the Gold Coast, now at Tweed Heads NSW and supplying the Brisbane Mater Children’s Hospital as well as some babies in the community);
 * Mercy Health Breastmilk Bank (commenced 2011 at Mercy Hospital for Women, Heidelberg VIC); and
 * Royal Brisbane and Women's Hospital (RBWH) Milk bank (commenced November 2012 at the RBWH Grantley Stable Neonatal Unit).
 * Mother's milk bank.

Similar to South Africa, Australia used to have many unofficial milk banks, until the threat of HIV and other transmittable diseases stopped the practice. However, in recent years, hospitals in Australia have opened 6 “official” milk banks to much popularity. In fact, the milk bank at RBWH has reported that they are struggling to keep up with the demand for donated breastmilk, as the benefits of breastmilk become more apparent.

The Australian Red Cross has also recently started a milk bank of their own, and is aiming in the short term to serve preterm babies in Southern Australia, where there are no milk banks. They hope to eventually have national coverage.