Human milk banking in North America

A human 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" (CDC). There are currently eleven milk banks in North America. They are usually housed in hospitals, although sometimes they are free standing. They are members of the Human Milk Bank Association of North America (HMBANA) and voluntarily abide by HMBANA's annually revised "Guidelines for the Establishment and Operation of a Donor Human Milk Bank." The guidelines were developed with the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) and include protocols for soliciting donors, collecting, processing and distributing the milk. Some of these protocols are described below.

According to a joint statement by the World Health Organization (WHO) and United Nations Children's Fund (UNICEF): "The best food for a baby who cannot be breastfed is milk expressed from the mother's breast or from another healthy mother. The best food for any baby whose own mother's milk is not available is the breastmilk of another healthy mother" (UNICEF, p. 48). "Where it is not possible for the biological mother to breast feed, the first alternative, if available, should be the use of human milk from other sources. Human milk banks should be made available in appropriate situations" (Wight, 2001).

Screening donors
Milk donors are new mothers who are in good health, whose infants are growing, thriving, and under six months old when they begin (Arnold, 1997). Because there is some risk of passing infections and viruses to babies through breast milk, donors must undergo a medical screening and a blood test to rule out infectious diseases such as HIV-1 and-2, hepatitis B and C and syphilis (Arnold, 1997). After administering a verbal or written questionnaire, healthcare providers for the mother and her baby must sign statements confirming that both are in good health.

The mother must not smoke or regularly use any medications, herbs, or megavitamins. If she or her baby has a common cold, she should not express milk for donation until they have recovered. If she consumes alcohol, she must wait out an "exclusion period" of twelve hours before expressing milk for donation. For a premature or medically fragile recipient baby, even a tiny amount of alcohol, medications, or herbs in the milk may be problematic.

Collection
Methods of collection and types of containers used vary among milk banks. Donors are educated about hygienic milk expression and given containers in which to express their milk. Some milk banks have collection points where couriers pick up donations, some have mothers deliver the milk to the facility, and others ask women who live far away freeze and ship their milk to the milk bank.

Screening and processing milk
In addition to careful screening of donors, each batch of milk is tested for bacterial counts before pasteurization. Some milk banks pool milk before testing it, others test each mother's milk as it comes in before it is pooled.

Milk banks require freezers and pasteurizers for processing milk. Most milk banks have two freezers, for unprocessed and processed milk. The HMBANA guidelines state that "all milk should be heat treated for 30 minutes at greater than 56°C. Heat treatment of milk occurs at 56°C for 30 minutes or 62.5°C for 30 minutes (Holder pasteurizing)" (Arnold, 1997, p. 243). At the end of pasteurization, another sample of milk is tested to make sure the treatment was effective. Colony counts should be zero and no bacterial growth should be detected (Arnold, 1997). Containers for pasteurizing must be able to withstand heating and cooling without breakage or leaking. Most containers are recyclable, usually glass or plastic.

Distribution
Donor milk is dispensed by prescription from the recipient's physician. Often, it is used within the hospital Neonatal Intensive Care Unit (NICU) for premature or critically ill babies. Sometimes, however, donor milk is shipped to recipients' homes. In these cases, it is frozen, packed in special containers, and shipped over night.

Breast milk content of mothers of premature babies differs from that of mothers of full term babies (Wight, 2001). Therefore, most milk banks separate "preemie milk" – milk collected in the first 30 days after delivery of an infant less than 36 weeks gestation – from "term milk."

Costs
The HMBANA Guidelines stipulate that donors not be paid for their milk. However, collection, processing and distribution of milk are expensive, and recipients are charged $3.00-$4.50 per ounce of milk to cover some of the cost. Community fundraising and grants also help milk banks meet expenses. The guidelines ensure that no one is denied donor milk for lack of ability to pay. For non-hospitalized recipients, the milk bank will often work with the family to obtain coverage for processing fees (Arnold, 1997). However, insurance companies rarely cover donor milk, except under unusual circumstances (Griffith, 2002). In some states, and under some circumstances, Medicaid and WIC will cover the costs of using banked milk (Arnold, 1999, Wight, 2001).

When hospitals order banked milk for their NICUs it is often brought into the pharmacy and billed through the hospital. In these cases, insurance companies are much more likely to cover the processing fees than for outpatients (Arnold, 1997).

Who gives?
Communities with milk banks use different methods to educate and solicit donors including brochures in doctors' offices and hospital information packets. Referrals also come from childbirth educators, nursing mothers groups, and La Leche League. Like blood banks, milk banks sometimes use newspaper, television and radio ads to solicit donors, especially when supplies are low (Arnold, 1997). NICUs with successful breastfeeding promotion and support often have mothers with excess milk, and they are frequently given information about how to donate their milk. In addition, mothers of infants who die sometimes choose to donate their milk.

Currently, many of the milk banks will receive milk from donors in states throughout the United States depending on their supply. Donors should always contact the closest milk bank first.

Who receives?
Premature infants are the most frequent recipients of donor breast milk. Full term babies with gastrointestinal (GI) disorders also sometimes receive banked milk. Occasionally, adopted babies and mothers who cannot nurse their healthy babies use banked milk as well, often at their own expense.

When there is milk available some milk banks will distribute it to adults who are immuno-compromised. Preliminary research indicates that breast milk can have nutritive, immunologic and palliative effects for cancer patients (Radetsky, 1999). Adults with GI disorders and organ donation recipients can also benefit from the immunologic powers of breast milk. More research is needed in these areas.

Risks
Two concerns are often raised by potential donor milk recipients and health care providers regarding potential risks of using banked human milk:

1. Viruses, including HIV, have been shown to transmit through breast milk. However, as mentioned above, breast milk donors are screened very carefully. In addition, each batch of milk is screened and pasteurized and retested for the presence of bacteria. "There have been no documented cases of disease transmission from donor milk provided by a milk bank operating under standard practice." (Arnold, 1999, p. 3) All of the milk banks listed below abide by the Guidelines of HMBANA.

Potential donors are excluded from donating under the following circumstances:
 * Receipt of a blood product or blood transfusion, or a tissue or organ transplant within the last 12 months.
 * Regular use of more than 2 ounces of hard liquor or its equivalent in a 24 hour period.
 * Regular use of over-the-counter drugs or systemic prescriptions (replacement hormones and some birth control hormones are acceptable).
 * Use of mega-dose vitamins and/or pharmacologically active herbal preparations.
 * Total vegetarians (vegans) who do not supplement their diet with vitamins.
 * Use of illegal drugs or tobacco products.
 * Silicone breast implants
 * A history of hepatitis, systemic disorders of any kind or chronic infections (e.g. HIV, HTLV, TB) (Arnold, 1999)

2. Some of the worthwhile components of breast milk are compromised in the pasteurization process. However, many are not. "Donor milk retains its bioactivity despite partial or complete loss of some components" (Arnold, 1999, p. 3). The enzymes in breast milk (e.g. lipase) appear to be most affected by the heat. However, immune factors are less sensitive to heat and growth factors and fatty acids are stable at pasteurization temperatures. The lower the temperature at which safe processing can take place the better (Arnold, 1999). HMBANA Guidelines reflect careful research in this area.

Milk banks in North America
Below is a list of states/provinces that have HMBANA member milk banks in North America:


 * British Columbia
 * California
 * Colorado
 * Delaware
 * Indiana
 * Iowa
 * Michigan
 * North Carolina
 * Ohio
 * Texas

Besides the individual milk banks in the above states/provinces, HMBANA has sent donor milk to hospitals in 29 states and 3 provinces.

Milk banking alternatives
Private milk donation is an alternative arrangement to milk donation through the Human Milk Banking Association of North America. Private donation is a less formal method of donation that involves direct connection between mothers donating milk and the families receiving donations. Many families engaging in private milk donation, include blood testing and complete donor screening while involving a supportive care provider. This is a modern continuation of the ancient concept of the wet nurse.