November 2011 Issue

Donor Milk Banks vs. Milk Sharing — Are They Competition or Complementary Services?
By Liesje Nieman Carney, RD, CSP, LDN
Today’s Dietitian
Vol. 13 No. 11 P. 44

CDR Codes 4140, 5060, 5070; Level 2

The majority of experts say human milk is the optimal source of nutrition for infants. Breastfeeding is increasingly accepted in workplaces and social settings, but in some cases it isn’t suitable for the mother due to illness or medication use. It would seem then that using donated breast milk would be a common and well-understood practice and that a system for providing it safely would be widely used.

Hospitals can access banks of screened and pasteurized breast milk, with premature and very ill babies receiving priority treatment. However, with limited supplies, many women who’d prefer breast milk are forced to use infant formulas.

With the advent of social networks on the Internet, however, women unable to receive donor milk from milk banks have organized their own sharing networks. Many applaud their enterprise and determination, but there are risks involved. With this phenomenon likely to grow, it’s important for dietitians to understand and advocate for more institutional milk banking and better education for sharing mothers. After all, as Akre and colleagues stated, “[M]other-to-mother milk sharing should be viewed as complementary to donor milk banking and not as its competitor.”1

To provide valuable input to hospitals and clinics on establishing donor systems, dietitians must know how milk banks are organized and how they work, and why the recent explosion of informal sharing is of concern.

Benefits of Human Milk
An in-depth discussion about the benefits of human milk is beyond the scope of this article, but a summary of key points is warranted to put this discussion in a suitable context. Feeding human milk decreases the incidence and severity of numerous infectious diseases,2 including bacterial meningitis, bacteremia, diarrhea, respiratory tract infection, necrotizing enterocolitis, otitis media, urinary tract infection, and sepsis in preterm infants.

Additional benefits of human milk may include decreased rates of sudden infant death syndrome, reduced incidence of insulin-dependent (type 1) and non–insulin-dependent (type 2) diabetes mellitus, lymphoma, leukemia, Hodgkin’s disease, overweight and obesity, hypercholesterolemia, and asthma. According to breastfeeding.com, “Infants with failure to thrive (FTT), formula intolerance, allergies, and certain other medical conditions may require real human milk for health and even for survival.” One statistic is striking: Postneonatal infant mortality rates in the United States are reduced by 21% in breastfed infants.2 Lastly, breastfed babies demonstrate slightly enhanced performance on cognitive development tests.

Unfortunately, some women can’t provide adequate and satisfactory breast milk for their infants, due to insufficient milk glands, past breast surgery or cancer, maternal illness, substance abuse, adoption, or treatment with medication that would pass through breast milk and be unsafe for the baby.3 There are also women who simply can’t produce an adequate volume of breast milk to meet their infant’s needs despite support from lactation consultants and the use of galactogogues (usually herbal preparations that promote or enhance lactation).

The common solution is to give the baby commercially available infant formula. However, doing so comes with inherent risks such as increased incidence of necrotizing enterocolitis (especially in premature infants). Although formula manufacturers strive to match the nutrient composition of human milk, certain components simply can’t be replicated, such as growth factors and immunoglobulins.

So the “breast is best,” and for most of human history women routinely have shared nursing duties with wet nurses, whether for convenience or out of necessity. With the growing urbanization of society in the 20th century, however, the social and family networks necessary for such informal arrangements became harder to sustain. Artificial feeding was still in its primitive stages and not considered by most to be a suitable alternative to human milk, so it became common in the late 19th century for lactating women to express their extra milk for use in feeding premature and ill children.

Reviewing the history of milk banking may yield some insights into how you should view today’s social networking phenomena.

History of Milk Banking
The first donor milk bank opened in Vienna in 1909, followed by the Boston Wet Nurse Directory in 1910, and then similar facilities in Germany.4 By the 1930s, many banks distributed sterile containers to donors and picked up milk daily.

In the early days, many milk banks compensated donors and charged hospitals from 10 to 30 cents per ounce for donor milk; the Boston bank paid an average monthly wage of $28 to each donor. Compensation for donors was an area of controversy for two reasons: One, there were valid concerns that mothers might withhold milk from their own babies in order to sell it; $28 was a significant amount of money back then. Two, there was an incentive for mothers to produce more volume that might lead to adulteration (eg, dilution) of donor milk.4 Ultimately, milk banks stopped paying donors and instead had to depend on the altruism of potential donors. Milk banks also stopped charging hospitals for donor milk, as it was perceived that they were doing so strictly to make a profit.

Two developments hindered this charity-based system: Mothers began entering the workplace in great numbers, and more babies survived at much younger gestational ages. Because of increased demand and limited supply, informal sharing networks have emerged.

The Human Milk Banking Association of North America (HMBANA) was created in 1985 in response to concerns about disease transmission in the casual sharing of human milk, with the goal of organizing current operating milk banks to develop standards for the assurance of safe practices in processing human milk. The HMBANA is comprised of 10 milk banks and six developing milk banks in Canada and the United States.5

The mission of the HMBANA is the following:

• Develop guidelines for donor human milk banking practices in North America.

• Provide a forum for information sharing among experts in the field on issues related to donor milk banking.

• Offer information to the medical community regarding the use of donor milk.

• Encourage research on the unique properties of human milk for therapeutic and nutritional purposes.

• Act as a liaison between member banks and governmental agencies.

• Foster communication among member banks to ensure adequate distribution of donor milk.

• Facilitate the establishment of new donor milk banks in North America using HMBANA standards.

All milk banks in the United States and Canada must follow the HMBANA guidelines, which are evidence-based best practices. The first set of guidelines was published in 1990 and is currently used around the world as a standard for donor milk banking. Similar to donor tissue banking, the milk banks rely on extensive testing, processing procedures, and self-reported health information. The HMBANA also requires a health statement from the donor’s healthcare provider.

The HMBANA has evaluated sharing networks with concern. In a position paper titled “Donor Human Milk: Ensuring Safety and Ethical Allocation,” it states, “The practice of casual sharing of milk or procuring milk from any source other than an established donor human milk bank operating under HMBANA guidelines, or similar guidelines established in other countries, has potential risks for both the recipient [and] the donor or her child.”6

Safety and Pasteurization
Before the advent of modern technology, most milk banks screened donors using the following methods: physical examination by a physician, a Wassermann blood test for syphilis, a social and personal history, and an examination of the woman’s baby for overall health. Interestingly, a donor’s milk was examined “chemically and bacteriologically for dilution of impurities once a month and the pooled milk (mixed milk from different mothers) once a week.”4

Similar to current milk banks, storage, pasteurization, and distribution of donor milk was a challenge. There were many trials and tribulations with regard to freezing and pasteurizing milk. By the 1930s, the Boston directory developed a quick-freezing method that involved pouring pasteurized human milk onto wafer molds placed on dry ice. Then the wafers of frozen milk were placed in sterile Mason jars and stored in a freezer. This method was readily adopted by other U.S. milk banks.4

Currently, HMBANA banks uniformly employ the Holder pasteurization method (62.5˚C for 30 minutes) and freezing at –20˚C.

Early methods of pasteurization almost certainly adversely affected many of human milk’s unique nutritional and immunological properties. It’s been purported by some researchers that current pasteurization methods alter the nutrient composition of donor milk, specifically decreasing fat and protein content, which could ultimately result in lower net energy consumption and cause slower rates of growth.7,8

Interestingly, a recent study reported that the fatty acid and amino acid content of donor milk isn’t substantially affected by pasteurization. On the other hand, this same study revealed that net concentrations of DHA and some amino acids were lower in donor milk compared with previously reported concentrations in human milk.9 Lactose content isn’t adversely affected by pasteurization.8

Another area of debate is whether pasteurization affects immunological properties, hormones, and growth factors in human milk. Akinbi and colleagues reported that several immunological properties in human milk were reduced by pasteurization when compared with freshly expressed milk, including lysozymes, lactoferrin, lactoperoxidase, and secretory immunoglobulin A (IgA).10 The Holder pasteurization method also has been shown to reduce adiponectin and insulin concentrations in donor milk.11

Although donor milk may not contain optimal levels of immunomodulating compounds and growth factors, it should still be considered a reasonable source of nutrition when the mother’s own milk isn’t available, as formulas don’t contain any of these properties.

It’s crucial that researchers continue to search for an optimal pasteurization method that will eliminate the risk of transmitting bacteria and viruses to the recipient, yet leave nutrient and immunological compounds unchanged. The high-temperature, short-time pasteurization method has shown promise, but more studies are needed.12

Who’s Eligible?
Because milk banks were created to provide pasteurized donor milk for premature and sick infants, donor milk requires a physician’s prescription. In 2004, HMBANA milk banks distributed 580,768 oz of donor milk; distribution rates almost tripled to 1,508,735 oz by 2009. Although the perception is that most donor milk recipients are in the acute care setting, in 2009 there was almost an even split between milk distributed to inpatients (56%) vs. outpatients (44%). In 2005, HMBANA milk banks sent milk to hospitals in more than 80 cities in 29 states.13

Hospitals often use donor milk to extend a mother’s milk supply or supplement while a mom receives support to increase her milk supply. Some facilities require formal consent from parents to provide donor milk, and others consider donor milk to be a standard of care and don’t require any parental consent. Some neonatal ICU (NICU) teams have a uniform policy to present donor milk as the first option when mother’s milk isn’t available; other facilities’ policies vary depending on the practitioner.

The HMBANA guidelines include recommendations for prioritizing the distribution of milk during shortages. In addition to premature infants, the following patient populations may qualify for donor milk14:

• malabsorption syndromes;
• congenital heart defects;
• failure to thrive;
• short bowel syndrome;
• feeding intolerance;
• severe allergies;
• IgA and other immune deficiencies;
• omphalocele;
• gastroschisis;
• intestinal obstruction/bowel fistula;
• intractable diarrhea;
• renal failure; and
• inborn errors of metabolism.

Typical donor milk recipients include very low birth weight infants (less than 1,500 g) whose mothers can’t provide breast milk or who produce an inadequate supply to meet the baby’s needs. A majority of the studies on the effectiveness of donor milk have been conducted with infants born prematurely.

Human milk for preterm infants empties from the stomach faster, enabling babies to better tolerate feedings; reduces intestinal permeability quicker; and results in less residuals and faster achievement of full enteral feedings. Factors in human milk may stimulate gastrointestinal growth, motility, and maturation. Enzymes naturally occurring in human milk help the absorption and utilization of nutrients and may also enhance nutrient absorption when human milk and artificial feedings (ie, commercially available formula) are combined.

Criteria for Donors
Typical donors are working mothers and women who are married, young, financially secure, well educated, and healthy.15 Pimenteira and colleagues studied what motivated donors and reported that the most common reasons for donating were “encouragement of a health professional” (61.3%) and “the needs of the babies the banks serve” (25.3%).16 Eligible donors must be currently lactating and have a surplus of milk, in good general health, willing to undergo a blood test at the milk bank’s expense, not be regular users of medication or herbal supplements (with the exception of progestin-only birth control pills or injections, Synthroid, insulin, and prenatal vitamins), and willing to donate at least 100 oz of milk (some milk banks require more).

According to the HMBANA website, a woman wouldn’t be accepted as a donor if she tests positive for HIV, human T-lymphotropic virus (HTLV), hepatitis B or C, or syphilis; if her sexual partner is at risk for HIV; if she uses illegal drugs, smokes, or uses tobacco products; if she received an organ or tissue transplant or a blood transfusion in the previous 12 months; if she regularly drinks 2 oz or more of alcohol per day; if she has been in the United Kingdom for more than three months or in Europe for more than five years since 1980; or if she was born in or has traveled to Cameroon, Central African Republic, Chad, Congo, Equatorial Guinea, Gabon, Niger, or Nigeria.

Although the HMBANA seems to have the logistics under control and is successfully providing safe donor milk for infants in need, the organization certainly has been the subject of scrutiny and criticism. Primary areas for concern include cost and quality.

Donor milk from milk banks is too expensive (many insurance companies won’t cover it). HMBANA milk banks don’t charge for the actual milk, but they do charge a processing fee to offset the milk bank’s overhead costs. This fee ranges from $3 to $5 per ounce, plus shipping costs. Each milk bank has the authority to determine the processing fee for its facility, which is the reason for the wide variation in price. In 2001, Wight published a cost analysis concluding that a NICU could save approximately $11 in treatment costs for each $1 spent on donor milk.3

Additionally, donor milk isn’t available to all infants, as it requires a physician prescription, and not all healthcare providers are aware that it’s a safe feeding option. Quality concerns are an issue as well since premature infants exclusively receiving pasteurized donor milk have slower rates of weight gain compared with a mother’s own milk or formula. As mentioned earlier, pasteurization changes nutrients and immune factors.

In general, human milk produces slower growth rates when compared with formula. This is a proven fact and has been the basis for development of new growth charts by the World Health Organization in recent years. Some studies have demonstrated slower rates of weight gain when infants were fed donor milk vs. formula. However, these early growth trends don’t seem to have long-term significance.17 Montjaux-Regis and colleagues compared mother’s own milk with pasteurized donor milk and concluded that mother’s own milk improves weight gain compared with donor milk in preterm infants.18 Because this was an observational study rather than an intervention trial, one can only speculate as to the reasons for this outcome.

Enter the ‘Lactivists’
Although informal milk sharing and institutional milk banks have a long-standing history, a recent event ignited the fires of passion of “lactivists.” In October 2010, breastfeeding advocate Emma Kwasnica had her Facebook account suspended on the grounds that her breastfeeding photos violated the company’s terms of use. In response, she organized a milk-sharing network. An organization called Eats on Feets (EOF) emerged, ironically using Facebook to connect women whose babies need supplemental breast milk to women living nearby who are willing to donate milk. Within a few weeks, EOF had grown to 98 local groups, in all 50 states and 22 countries.

According to the main EOF Facebook site, the goal of the organization is to “facilitate access to human milk for babies and children; the chapters provide a commerce-free space where women can share their milk in a safe, ethical manner.” The site emphasizes that it does not support or approve of the selling of breast milk on its network; offer medical advice or clinical care; screen donors or recipients; provide contracts or questionnaires; decide who should receive breast milk; collect, store, or distribute breast milk; receive money, payment, donations, or funding of any kind; reimburse volunteers/supporters; act as mediators or advisors if difficulties or misunderstandings occur between parties; accept liability for the outcomes associated with sharing breast milk; or expect mothers to try to increase their supply in order to donate or receive milk.

In addition to EOF, several other milk-sharing sites have surfaced. By July, more than 4,000 people had “liked” the Human Milk 4 Human Babies (HM4HB) Global Network on Facebook. The HM4HB’s mission is to “promote the nourishment of babies and children around the world with human milk … dedicated to fostering community between local families who’ve chosen to share breast milk.” Additional sites of interest include www.milkshare.org.uk, which declares it’s providing information on safety for those considering milk sharing, and www.phdinparenting.com/2010/11/28/risks-of-informal...-breastmilk-sharing-versus-formula-feeding, which claims to provide a balanced review of the risks of milk sharing.

One novel feature of these sites is that their users experiment with different delivery methods. According to EOF, many mothers forgo the use of bottles and instead use an at-the-breast system, which involves the use of a container attached to a small feeding tube that’s either taped to the breast or placed inside the baby’s mouth while the baby is latched onto the breast. Similar logistics are used in NICUs (eg, supplemental feeders), based on the theory that the baby will receive the donor milk while still stimulating the mother’s breast and consuming whatever volume the mother produces.

Milk-sharing sites emphasize that women should exercise “informed choice.” Many sites have prominent disclaimers of responsibility and tips for reducing risk when receiving donor milk, including guidelines for interviewing and evaluating potential donors. Safety is a concern. One such advisory, posted on the EOF home page on March 15, mentioned “at-home heating” but cautioned that “flash-pasteurizing is a commercial method that requires special equipment and cannot be duplicated in a home setting. What can be done at home is called flash-heating. The only virus that this method has demonstrated to inactivate is HIV. While flash-pasteurizing has been shown to inactivate HIV, HTLV, HBV and HCV, and CMV as well as markers for many other viruses, the effectiveness of flash-heating on viruses other than HIV is theoretical.” Such caveats should give mothers pause—and perhaps initiate a government response.

Where Is the FDA (and the ADA)?
In December 2010, the FDA’s pediatric advisory committee discussed donor and banked human milk and the stated goal of bringing together national experts to discuss the safety, ethics, and regulatory implications of donor human milk. Full transcripts of the meetings as well as all supplemental materials presented by experts can be found at www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/
ucm201871.htm
.

Lengthy discussion among experts in the field of neonatology and infant nutrition made little progress toward regulatory oversight or consensus on the future of milk banking. The FDA agrees that the HMBANA guidelines are effectively producing safe donor breast milk, urges more research is needed to determine the nutritional adequacy of donor human milk and, significantly, doesn’t condone informal milk sharing due to the inherent risks and lack of controls. A telling quote from the meeting transcript: “Unregulated human milk trafficking is a huge problem, and it really could blow up in all our faces and all the ground that we’ve gained, and the benefits of feeding human milk to premature babies will be lost because it will all go down the tubes together as breast milk. It’s a big issue clinically.”

And it’s a big issue for dietitians. With the prospect of profligate sharing of breast milk without adequate safeguards, dietitians and lactation consultants may be the only professionals able to counsel mothers on whether to do it and how to do it safely. We need to unite as a profession to discuss standardization for the use of donor milk.

— Liesje Nieman Carney, RD, CSP, LDN, is a pediatric dietitian at The Children’s Hospital of Philadelphia and a freelance writer.

 

Acknowledgment
I’d like to thank Ginger Carney, RD, LDN, IBCLC, RLC, FILCA, director of clinical nutrition services at St. Jude Children’s Research Hospital, for sharing her enthusiasm for lactation and providing feedback on my work.

 

Learning Objectives
After completing this continuing education activity, nutrition professionals should be better able to:

1. Assess at least five benefits of human milk.

2. Interpret the rationale for using donor milk.

3. Evaluate the differences between milk banking and milk sharing.

4. Discuss the mission of the Human Milk Banking Association of North America.

 

Examination
1. Which of the following are reasons why a mom may not be able to provide milk for her infant?
a. Insufficient milk glands
b. Past breast surgery or cancer
c. Maternal illness or substance abuse
d. All of the above

2. Postneonatal infant mortality rates in the United States are reduced by 21% in breastfed infants.
a. True
b. False

3. The first milk bank in the United States was opened in:
a. Boston in 1910.
b. Denver in 1923.
c. San Jose in 1915.
d. Vienna in 1909.

4. Which of the following is the reason milk banks no longer pay donors?
a. Donors may dilute their milk to get paid for more volume.
b. Donors may withhold milk from their own babies in order to sell it.
c. A and B
d. None of the above

5. Which method is used by the Human Milk Banking Association of North America (HMBANA) milk banks to pasteurize donor milk?
a. Holder pasteurization method
b. High-temperature, short-time pasteurization method
c. Flash heating
d. Addition of antibiotics
e. Irradiation

6. Milk banks will provide pasteurized donor milk for which of the following conditions:
a. Failure to thrive
b. Prematurity
c. Feeding intolerance
d. Severe allergies
e. All of the above

7. HMBANA milk banks distributed more than 1.5 million oz of donor milk in 2009.
a. True
b. False

8. Which of the following women would not be accepted as a donor to a HMBANA milk bank?
a. Had a positive blood test result for human T-lymphotropic virus
b. Smokes on occasion
c. Received a blood transfusion six months ago following a car accident
d. Willing to donate 30 oz of milk
e. All of the above

9. What is the goal of milk banks charging a processing fee for donor milk?
a. Profit
b. Offset overhead costs
c. Support research
d. Cover shipping costs

10. Which of the following are common criticisms of donor milk from U.S. milk banks?
a. Too expensive
b. Not available to all infants
c. Requires a prescription
d. Pasteurization changes nutrients and immune factors
e. All of the above

 

References
1. Akre JE, Gribble KD, Minchin M. Milk sharing: From private practice to public pursuit. Int Breastfeed J. 2011;6:8.

2. Gartner LM, Morton J, Lawrence RA, et al. Breastfeeding and the use of human milk. Pediatrics. 2005;115(2):496-506.

3. Wight NE. Donor human milk for preterm infants. J Perinatol. 2001;21(4):249-254.

4. Jones F. History of North American donor milk banking: One hundred years of progress. J Hum Lact. 2003;19(3):313-318.

5. Human Milk Banking Association of North America. HMBANA milk bank locations. Available at: http://www.hmbana.org/milk-bank-locations. Accessed September 19, 2011.

6. Human Milk Banking Association of North America. Donor human milk: Ensuring safety and ethical allocation. Available at: http://www.hmbana.org/downloads/position-paper-safety-ethical.pdf. Last accessed September 19, 2011.

7. Wojcik KY, Rechtman DJ, Lee ML, Montoya A, Medo ET. Macronutrient analysis of a nationwide sample of donor breast milk. J Am Diet Assoc. 2009;109(1): 137-140.

8. Vieira AA, Soares FV, Pimenta HP, Abranches AD, Moreira ME. Analysis of the influence of pasteurization, freezing/thawing, and offer processes on human milk’s macronutrient concentrations. Early Hum Dev. 2011;87(8):577-580.

9. Valentine CJ, Morrow G, Fernandez S, et al. Docosahexaenoic acid and amino acid contents in pasteurized donor milk are low for preterm infants. J Pediatr. 2010;157(6):906-910.

10. Akinbi H, Meinzen-Derr J, Auer C, et al. Alterations in the host defense properties of human milk following prolonged storage or pasteurization. J Pediatr Gastroenterol Nutr. 2010;51(3):347-352.

11. Ley SH, Hanley AJ, Stone D, O’Connor DL. Effects of pasteurization on adiponectin and insulin concentrations in donor human milk. Pediatr Res. 2011;70(3):278-281.

12. Baro C, Giribaldi M, Arslanoglu S, et al. Effect of two pasteurization methods on the protein content of human milk. Front Biosci (Elite Ed). 2011; 3:818-829.

13. Human Milk Banking Association of North America. PowerPoint presented at: Food and Drug Administration Pediatric Advisory Committee meetings; December 2010. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Pediatric
AdvisoryCommittee/UCM235619.pdf
. Accessed September 19, 2011.

14. Arnold LDW. The role of donor milk in the reduction of infant mortality and morbidity: A child survival issue. The Health Children 2000 Project, 1996.

15. Osbaldiston R, Mingle LA. Characterization of human milk donors. J Hum Lact. 2007;23(4):350-357.

16. Pimenteira TAC, Maia Loureiro LV, da Silva OT, et al. The human milk donation experience: motives, influencing factors, and regular donation. J Hum Lact. 2008;24(1):69-76.

17. Boyd CA, Quigley MA, Brocklehurst P. Donor breast milk versus infant formula for preterm infants: systematic review and meta-analysis. Arch Dis Child Fetal Neonatal Ed. 2007;92(3):F169-175. Epub 2006 Mar 23.

18. Montjaux-Regis N, Cristini C, Arnaud C, Glorieux I, Vanpee M, Casper C. Improved growth of preterm infants receiving mother’s own raw milk compared with pasteurized donor milk. Acta Paediatr. 2011; June 24. (Epub ahead of print).