A. Response (from an article by Lois D. W. Arnold, PhD, MPH:

When did it begin?
The first donor milk bank in the US was established in Boston in 1911 at the Floating Hospital for Children, now part of New England Medical Center. Human milk was collected daily from donors who were screened for infectious disease and cleanliness. The milk was used to feed premature babies and babies who were sick and/or hospitalized. One of the more common uses of donor milk was to treat summer diarrheal diseases, usually associated with feeding of contaminated and unrefrigerated cow milk-based feedings. All donated milk was pasteurized before distribution. Donor milk banking thrived in Boston for several decades.

Is there a New England milk bank now?
The last milk bank in New England that distributed milk regionally was in Worcester, MA. Founded in 1975, along with numerous other milk banks nationally, the milk bank distributed milk primarily to premature infants, and was based at Memorial Hospital when it closed for financial reasons in the mid 1990’s. The Central Massachusetts Regional Milk Bank distributed donor milk to recipients in a number of states as well in Massachusetts. Donor milk currently used in New England must be shipped in frozen from one of the other Human Milk Banking Association of North America (HMBANA) milk banks on a case-by-case basis. A current list of HMBANA member milk banks and their locations may be found at www.hmbana.org.

Who oversees milk banks in the US?
The Human Milk Banking Association of North America is the umbrella association of which most non-profit milk banks in the US are members. HMBANA has developed guidelines for the establishment and operation of human milk banks that all member milk banks are required to follow. These guidelines have been developed in consultation with representatives of the CDC, FDA, and Infectious Disease Committees of the American Academy of Pediatrics. The guidelines are reviewed and updated every two years, or sooner for emergent tissue transplant issues. Currently there is no federal regulation of donor milk banks; only the States of California and New York have regulations that require that a donor milk bank be a licensed tissue bank and regulated by the state Health Department.

How can one access banked human milk now?
Any of the HMBANA milk banks will supply donor milk upon receipt of a mandatory doctor’s prescription. When milk is ordered this way it is shipped frozen by next-day air to the hospital or individual recipient.

How much does donor milk cost?
Milk is given voluntarily to HMBANA milk banks by donors. However, HMBANA milk banks do charge a processing fee to help defray some of the costs of donor screening and milk processing. Currently, this fee averages $3.50-$4.00 per ounce. Shipping may or may not be included in this fee, depending on the milk bank. However, the Guidelines by which HMBANA milk banks operate suggest that no one should be denied access to donor milk for inability to pay the processing fee.

Is this processing fee covered by insurance?
It depends on the insurance plan covering the recipient. Medicaid programs in many states will cover the cost of the processing fee. Coverage varies with private insurers as well since they may perceive human milk to be simply a food and do not cover what they consider to be a special nutritional. However, physician advocacy on behalf of the patient has been known to be effective in assuring reimbursement.. If the physician argues that the therapeutic use of donor milk will save money for the insurance company in future care requirements of the recipient, the insurer is more likely to cover the fee.

How does donor milk banking work?
HMBANA member milk banks all operate according to well-established and frequently updated guidelines that have been developed in consultation with infectious disease and quality control experts.

Volunteer donors contact a milk bank that then screens the donor according to standards similar to those of blood banks. Volunteer donors do not receive any reimbursement or gifts for their participation - they donate their milk strictly for altruistic reasons.

A thorough verbal questionnaire is used as a preliminary donor screening. If a donor is found to be acceptable after the verbal screening, then a blood test for HIV, Human T-Cell Leukemia Virus (HTLV), Hepatitis B, Hepatitis C, and syphilis is performed. If the mother is negative for these diseases, is a non-smoker, has no chronic disease or condition, and is not taking or using prescription, over-the-counter, or herbal preparations on a regular basis she is most likely acceptable (To see a list of donor exclusions, go to the HMBANA web site: www.hmbana.org).

As the donor collects milk she freezes it and then transports it to the milk bank. If long distance transport is involved, the milk bank will usually pick up the cost of shipping. At the milk bank, milk from several different mothers is thawed, pooled and pasteurized. To ensure quality control, bacteriological testing is done prior to distribution. No milk is distributed unless there is no bacterial growth in the cultures.

When is donor human milk used?
Banked donor milk is primarily used for infants and young children with a medical need for human milk. It is never substituted for a mother’s own milk when that supply is ample and available. However, it may be used to supplement a mother’s milk supply when it is inadequate or use of the mother’s own milk is contraindicated for some reason.

Occasionally, older children and adults also have medical indications for donor milk.

What are some of the clinical uses of banked donor milk?

• Prematurity
• Malabsorption syndromes
• Hirschprung’s disease
• Inborn errors of metabolism
• Chronic renal failure
• Biliary atresia
• Failure to thrive
• Short-gut syndrome
• Feeding intolerances/allergies
• Pediatric burn cases
• Seizure disorders
• Cardiac problems
• Post-surgical nutrition/healing (gastroschisis, omphalocele, intestinal obstruction/bowel fistula, colostomy repair, eye surgeries)
• Treatment for infectious diseases (intractable diarrhea, gastroenteritis, infantile botulism, sepsis, pneumonia, hemorrhagic conjunctivitis)
• Solid organ transplants (provides IgA to deficient recipients and reduces rejection episodes and potential for loss of organ due to infection)
• Non-infectious intestinal disorders (ulcerative colitis, irritable bowel syndrome, ulcers)
• Cancer therapies (in adults and children as either stand-alone therapy or as adjuvant therapy
• Prevention for some diseases and conditions (necrotizing enterocolitis, allergies to bovine and soy milks, Crohn’s disease, colitis)

Why should I order human milk from a HMBANA milk bank rather than get it from a friend or over the Internet?
Informal sharing/borrowing of human milk among friends is not a safe practice. Human milk is not sterile. Potentially dangerous viruses and bacteria can be transferred through human milk. If a baby is exposed to a virus such as Herpes, for example, through the milk of another mother, then the recipient baby could be infected and become very sick. The risk includes HIV, as well as other viruses and bacteria that could have the potential to cause serious harm. Home treatment of milk does not make it safe to share.

Friends and family members may not be forthcoming about their own sexual habits or they may be unaware of partners’ sexual practices, placing the recipient of shared milk at unknown risk.

Purchase of milk over the Internet is even more risky. The producer of the milk may not even be human! Cow milk or goat milk could easily be substituted. The cleanliness of the milk is certainly not monitored. And there are no safeguards through pasteurization and donor screening to ensure quality and safety of the milk.

Lois D. W. Arnold, PhD, MPH, IBCLC