- Email: [email protected]
Human Milk Banking in the United States
CLINICAL PRACTICE
Abstract Approximately 30 milk banks existed in the early 1980s in the United States, whereas seven banks currently exist in the United States and one in Canada. Recently, there has been a resurgence of interest in human milk banks as evidenced by the number of institutions in various stages of developing new human milk banks. During 2003, North American milk banks processed more than 500, 000 ounces of donated human milk that was used in individuals with a variety of diagnoses. Human milk banking continues to evolve and grow as new information on the nutritional composition of milk and the needs of the neonate, as well as the benefits of donor human milk for the fragile infant, are anticipated, as discussed by Arnold [Arnold LD: The cost-effectiveness of using banked donor milk in the neonatal intensive care unit: prevention of necrotizing enterocolitis. J Hum Lact 18:172–177, 2002]. Based on the number of premature infants in North America, the number of potential recipients is not likely to diminish anytime soon. The expanding numbers and capacity of existing milk banks can meet this need. As the public and neonatal community awareness of donor human milk benefits and safety grows, the demand for this precious commodity may increase. This article provides an overview of human milk banking and describes in more detail the specific practices of the human milk bank in Austin, Texas. n 2005 Elsevier Inc. All rights reserved.
From the Mothers’ Milk Bank at Austin, Austin, TX. Address reprint requests to Kim Updegrove, MSN, RN, CNM, MPH, Mothers’ Milk Bank at Austin, 900 East 30th Street, Suite 214, Austin, TX 78705. n 2005 Elsevier Inc. All rights reserved. 1527-3369/05/0501-0003$30.00/0 doi:10.1053/j.nainr.2005.02.005
Human Milk Banking in the United States By Kim Updegrove, MSN, RN, CNM, MPH
M
eeting someone new and asking about their work can either lead to a very interesting discussion or a dead end in the conversation. Certain professions startle people. Funeral directors and dentists understand this. As a certified nurse midwife, this writer has learned to anticipate a mixed reaction to my job title; however, this response pales in comparison to the reaction I get when I say I am the clinical coordinator of the Mother’s Milk Bank at Austin (MMBA) in Austin, Texas. The MMBA does not have automated teller machines or carry much cash; instead, it stores and processes human milk collected from screened donors and dispenses it to medically needy individuals or to hospitals for use in their institutions. North American human milk banks processed more than 500, 000 ounces of donated human breast milk in 2003 (Fig 1). In 2003, donor human milk was used for a variety of diagnoses in the United States and Canada that included medical treatment, prevention of disease, and nutritional support (Table 1). This article will provide a general overview of milk banking and a more detailed look at specific practices of the MMBA.
Human Milk Bank
A
ccording to the Human Milk Banking Association of North America (HMBANA), ba donor human milk bank is a service established for the purpose of collecting, screening, processing, storing, and distributing donated human milk to meet the specific needs of individuals for whom human milk is prescribed by health care providers who are licensed to prescribe.Q1 HMBANA is the professional association for human milk banks in Canada, Mexico, and the United States and was founded in 1985. The purposes of HMBANA are listed in Table 2. Milk banking is not a new concept; historically, most babies were fed human milk, either their own mother’s milk or donated human milk from a wet nurse. The first of many milk banks in North America was founded in Boston, Massachusetts, as a home for lactating women who were paid to wet-nurse needy infants.2 The development and successful marketing of bovine formulas changed this situation in the 1900s and, along with other factors, were influential in altering the expectation that an infant would receive human milk regardless of its mother’s ability to provide the milk herself.2– 4 Hospital budget crises, decreased breastfeeding rates, fears of viruses, and other illnesses potentially spread through breast milk led to multiple closings of the banks.4 Human milk banks are now experiencing a resurgence of interest and resources.5 Although approximately 30 milk banks existed in the early 1980s in the United States, only seven banks currently exist in the United States and one in Canada (Fig 2).6 A new milk bank category, which is also under HMBANA Newborn and Infant Nursing Reviews, Vol 5, No 1 (March), 2005: pp 27–33
27
28
Kim Updegrove
,C al if D en ve r, C ol Io o w a C ity ,I ow a R al ei gh ,N C Au Va st nc in ou ,T ve ex rB C ,C an ad a
Jo Sa n
Table 2. Purposes of HMBANA1 Purpose
200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 se
Ounces
Milk Banks of HMBANA, 2003 Dispensed Ounces
! Develop guidelines for milk banking in North America ! Provide a forum for information sharing among those in the field of donor milk banking ! Provide information to the medical community regarding use of donor milk ! Encourage research into the unique therapeutic and nutritive properties of human milk ! Act as a liaison between member banks and governmental agencies ! Facilitate communication among member banks ! Facilitate the establishment of new donor milk banks
Milk Bank
Fig 1. Dispensed human milk from milk banks in the United States and Canada.
guidance, is emerging—the developing milk bank.7 The developing milk bank refers to those organizations that have taken a number of steps toward organizing efforts to open a new milk bank but have not yet begun to process and dispense human milk. Many hospitals operate what are called bmother’s own milkQ banks.8 Mother’s own milk banks consist of services within hospitals in which mothers can express breast milk for their hospitalized infants and store it for future use by their own infant. This milk is not processed in any way, and it is not shared with other infants.
Donors
H
uman milk donors are healthy lactating women who choose to share their excess breast milk. Donors
Table 1. Uses of Banked Human Milk in 20031 Medical and Therapeutic
Nutritional
Short gut syndrome
Prematurity
Infectious diseases Postsurgical healing
Failure to thrive Malabsorption syndromes Feeding intolerance
Immunologic diseases Renal failure Inborn errors of metabolism
Preventive Health Necrotizing enterocolitis AIDS Crohn disease Colitis
must take minimal or no medications and no herbal products. Human milk supply may naturally be higher than required for the donor’s infant or can be stimulated through increased breast pumping. A lactating mother of a deceased infant may contribute milk that was intended for her infant. The decision to donate human milk requires a sense of commitment to the community. Donors are not paid, but they do have the satisfaction of knowing that they have helped others. This sense of satisfaction is apparent in the following quotation from a donor mother. bI gave birth to twins—a boy and a girl—in the summer of 2002. In spite of carrying them to term, my daughter ended up in neonatal intensive care unit (NICU) for several days. The first time I saw her lying there in the Isolette with all those wires sticking out of her and her ferocious little frown really broke my heart. I was afraid to touch her. I was quickly brought to reality though, by looking around at the other babies and mothers in NICU. My tiny, rosy, little 4-pound 11-ounce daughter was a giant compared with her preterm neighbors. And my 8-day stay, although it seemed like forever to me, was nothing compared with that of those tired parents who were making the trek back and forth to NICU for weeks on end. When I learned about the milk bank, I jumped at the chance to donate breast milk. I was so happy to give something so meaningful to all those tiny babies in NICU. I felt privileged to have gotten a glimpse of their fragile little lives, but also so grateful that it was only a glimpse. My daughter went home and is now an energetic and thriving toddler. Maybe my milk helped one of those other tiny ones get home to a more normal life a bit sooner. I am grateful to the milk bank for the opportunity to help other families in this way.Q
Donors are self-selected—they determine their ability and interest in sharing their milk. They may not have known about donor milk banking before feeding their own infant; however, once informed, they like the idea. Mothers find out about donating human milk in much the same way they find out about car seats or any other baby-related topic—they read about it in a parenting magazine; hear about it from a prenatal care provider or
Human Milk Banking in the United States
29
Fig 2. Locations of established and developing milk banks in North America. Used with permission from HMBANA. Available at: http://www.hmbana.org.
childbirth educator or during breastfeeding preparation classes, hospital staff, family, or friends; or read about it on the Internet. Word of mouth is powerful when promoting donor milk banking, and the success of milk banks is testimony to this. A total of 938 donors were screened by North American milk banks in 2003 (M. Tagge, personal communication, January 2, 2005). The donor screening process follows HMBANA guidelines and is very similar to human blood bank guidelines.9 Based on scientific research, these guidelines incorporate knowledge of transmission of viruses and bacteria through body fluids, the transference of medications and herbs through breast milk, and the risks of certain lifestyles for various diseases. Specific screening processes across the milk banks may differ slightly, but each meets the requirements of HMBANA.
Donor Screening
A
t MMBA, the screening process begins when a lactating mother calls the office and asks about donating her milk. A short conversation follows in which questions regarding the mother’s and baby’s health, her lifestyle, and maternal medical issues are explored. This usually leads to a preliminary decision about the appropriateness of the individual as a milk donor. Donors are permitted to use a limited number of medications that include hypothyroid medications, insulin, and progestinonly birth control methods. Herbal use is not accepted because of a lack of clinical data on the risks of these
substances to the nursing infant. Donors frequently are taking mothers’ milk tea (a beverage made from a combination of fennel, anise, fenugreek, coriander seed, and blessed thistle herb) or domperidone to stimulate milk supply; however, these substances have not been studied for their effects on the neonate, especially the premature infant. Donor mothers must agree to stop using these herbs and cannot donate until after the specific clearance time has passed. After passing the preliminary phone screening, a packet of information is mailed to the approved donor. The information describes how to pump and store milk in acceptable containers for donation and explains the required blood tests—human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotrophic virus, hepatitis B, hepatitis C, and syphilis. Medical release forms that give MMBA permission to contact the infant’s care provider and the prenatal care provider for signed statements about the health of the donor and her baby are also included in the packet. Although the blood tests required may repeat some of the tests that were already done during the prenatal period, the second set of tests provides an updated medical picture of the donor and allows for comparison with the earlier blood work. The blood work requirement also emphasizes the strict control over the quality of the donated milk. Once all paperwork is returned and the blood work obtained, this information is reviewed by the clinical coordinator, and the donor is either approved, denied, or asked to answer more questions before a decision can be made. Donor exclusion criteria are defined by HMBANA and include regular use of medication (other than the previ-
30
Kim Updegrove
208C. Each donor’s milk is identified by a unique donor identification number that allows a staff member to verify that this is a screened donor. The milk is kept in the freezer at these depots until a volunteer or milk bank staff member can transport it to the milk bank.
Milk Processing
D
Fig 3. Donor mother reassembling a breast pump after cleaning. Used with permission from HMBANA. Available at: http:// www.hmbana.org.
ously mentioned acceptable drugs) or herbal use, any positive serum test on required blood tests, risk factors for HIV or hepatitis, use of illegal drugs, use of nicotine products, regular alcohol intake (12 hours must lapse before collection of human milk following any alcohol consumption), or travel to the United Kingdom for more than 3 months between 1980 and 1996 or more than 5 years at any time.1
onor milk undergoes pasteurization at the MMBA. Milk from approved donors is selected twice per week for this process. Once selected for a specific day of pasteurization, the milk is thawed, poured into flasks (Fig 4), and mixed carefully to homogenize any solid components (eg, fat). A sample is taken for microbiologic screening and is plated for identification and counting of bacterial colonies. Pasteurization eliminates most skin and some gastrointestinal flora that are present in human milk.10,11 Human milk that tests positive for certain bacteria including Staphylococcus aureus, methicillinresistant S aureus, and any of the bacillus species are discarded and not subjected to further processing. Although the pasteurization technique kills S aureus and methicillin-resistant S aureus, these microorganisms can release an endotoxin or enterotoxin that could, theoretically, cause gastrointestinal problems for the recipient infant. Enterotoxins are heat-resistant, so pasteurization may not render them harmless.12 Because some bacteria are heatloving organisms, a second culture is obtained after the heating process. The bacillus species are one such organism and will grow during pasteurization if the spores are active.13 The second culture also serves to verify that no microorganisms were introduced during the pouring and pasteurization process. No bacteria, pathogenic or not, are
Milk Donation
D
onor milk can be expressed manually or through use of a breast pump. Donors must adhere to pumpcleaning instructions and advice about milk storage to limit contamination by pathogens. Modern breast pumps tend to easily assemble and disassemble for cleaning (Fig 3). MMBA requires the donor to bring in a minimum of 100 ounces of expressed milk. Donors may deliver the expressed milk to the milk bank itself or to one of a number of depots or collection sites in her area. Milk collection sites are generally located within medical facilities or on the grounds of a medical facility where at least one staff member has been trained on proper storage of donor milk. The milk is placed in an acceptable freezer within the facility maintained at a temperature of
Fig 4. Donor milk in flasks waiting for target pooling. Used with permission from HMBANA. Available at: http:// www.hmbana.org.
Human Milk Banking in the United States
31
Fig 5. MilkoScan FT120. Used with permission from HMBANA. Available at: http://www.hmbana.org. Fig 7. Nutritional labeling. Used with permission from HMBANA. Available at: http://www.hmbana.org.
tolerated in the postpasteurization culture. Any positive postpasteurization colony leads to the discarding of that donor’s milk. A second sample is taken from the thawed donor’s milk before pasteurization for nutritional analysis. This is not a requirement of HMBANA guidelines, but rather is done because human milk has a wide range of nutrients especially with regard to fat.14 MMBA has worked with the US Department of Agriculture dairy laboratory in Carrolton, Texas, and the manufacturer of the MilkoScan FT120 (Foss North American, Inc; Eden Prairie, MN) to develop a process for conducting nutritional evaluation of human milk. The MilkoScan FT120 is a device used by the dairy industry to evaluate dairy products using infrared technology (Fig 5). Both Foss and the US Department of Agriculture continue to work with the MMBA in evaluating the accuracy of nutritional information No. of oz: August to December 31, 2003 (Total = 48,892) 30000
Number of ounces
25000
obtained. After recalibrating the machine to evaluate human milk, the MilkoScan is used to target pooled donor milk. Target pooling is a process in which the milk from specific donors is mixed together in certain volumes to ensure a minimum caloric and protein value for the milk. This process maximizes the usability of donor breast milk for hospitalized infants. Donor human milk is dispensed for hospital use if it is z19.5 kcal/oz (z81.9 kJ/oz). Rounding to the nearest tenth degree, the milk is labeled as 20 kcal/oz (84 kJ/oz), 22 kcal/oz (92.4 kJ/oz), or 24 kcal/ oz (100.8 kJ/oz) for hospitals. Milk that is less than 19.5 kcal/oz (81.9 kJ/oz) but greater than 16.5 kcal/oz (69.3 kJ/ oz) is used for outpatient recipients. Milk that is less than 16.5 kcal/oz (69.3 kJ/oz) is discarded. Typically, two to three donor milks are included in a pool. Fig 6 describes target pool outcomes during the period from August to December 2003. After target pooling, another sample is taken and tested for nutritional content. This sample is used to verify the prediction made from individual donor milk samples. It also provides the nutritional data printed on the labels of bottles (Fig 7).
20000 15000
Milk Pasteurization
10000
D
5000 0 No. of oz unusable (0.9%)
Outcome
No. of oz No. of oz No. of oz No. of oz outpatient 20 Kcal/oz 22 Kcal/oz 24 Kcal/oz (under 19.5) (19.5 to 21.4) (21.5 to 23.4) (23.5 to 25.4) (29%) (58%) (12%) (0.8%)
Fig 6. Target pool outcomes from August to December 2003.
onor human milk has come a long way since the days of wet nursing and sharing of raw milk among babies. The potential of maternal viral shedding led to the standard practice of pasteurizing donor milk. Currently, HMBANA guidelines call for the use of Holder pasteurization, which is a long-term low-temperature technique.15 During Holder pasteurization, the milk is placed in a shaking water bath and heated to 62.58C for 30 minutes (Fig 8). The critical nutritional components of fat, protein,
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Kim Updegrove
children or adults with a variety of chronic and acute disorders. The use of human donor milk in adults and older children is not well researched at this time; however, theoretically and anecdotally, it may help those with immune disorders, allergic disorders, or intestinal diseases.
Cost
A Fig 8. Holder pasteurization. Used with permission from HMBANA. Available at: http://www.hmbana.org.
and carbohydrate are stable throughout this process.16–19 Immune factors are minimally compromised, but partial or complete losses of B-cell and T-cell components of the milk, lymphocytes, and specific antibodies such as immunoglobulin A are lost during pasteurization.15,20–22 Donor human milk is pasteurized in the bottles in which the milk will be dispensed. Following pasteurization, the milk is quickly cooled in an ice bath and frozen for dispensing. One bottle from each batch within a pool is taken after pasteurization, and another sample is taken and sent to a microbiology laboratory to check for pathogens or other bacterial growth. A sample is also taken to recheck the nutritional content. Aseptic technique is used throughout the processing of donor human milk.
Dispensing Milk
H
ospitals with a need for donor human milk call the nearest milk bank and place an order for their anticipated volume need. The milk is delivered locally by volunteers or milk bank staff. Milk going to nonlocal hospitals is packaged with dry ice and shipped overnight or delivered by courier. Once at the target NICU, the donor milk is kept frozen until it is needed. Thawing and other handling of donor breast milk are the same as the practices used with a mother’s own milk for her baby. Outpatients may also use donor human milk. In these cases, a health care provider supplies the milk bank with a prescription for donor milk and a brief letter of medical necessity. The milk is then delivered to an individual household the same way it is delivered to hospitals. Most outpatient recipients of donor milk are infants who were not able to be weaned from donor human milk by the time of discharge or for whom weaning was not medically advisable. Occasionally, donor milk is prescribed for older
s previously stated, donors of human milk are not paid for their breast milk. Because the processing and screening of donor milk are costly, these costs are reflected back to the hospitals when they order donor human milk. Although the price per bottle may differ slightly across the banks, the average cost is approximately US$3 to US$3.50 per ounce. Hospitals are also responsible for shipping costs. Outpatients also pay a processing fee for donor milk. In some cases, private insurance companies will cover this cost; in others, the family is responsible. Although Medicaid requirements differ by state, many state Medicaid programs will cover some portion of the cost of donor milk if the relevance of the milk to the infant’s diagnosis is approved. Milk banks also provide milk to many outpatients who do not have private insurance and who cannot pay for the milk. Grants and individual donations help to make up for these losses to the banks.
Conclusion
H
uman milk banking continues to evolve and grow, as new and greater information on the nutritional composition of milk and the needs of the neonate, as well as the specific benefits of donor human milk for the fragile infant, are anticipated.23 Based on the number of premature infants in North America, the number of potential recipients is not likely to diminish anytime soon, despite our best efforts to improve the breastfeeding rate. The expanding numbers and capacity of existing milk banks can meet this need. As the public and neonatal community awareness of donor human milk benefits and safety grows, the demand for this precious commodity may increase.
Acknowledgment
T
he author thanks Gretchen Flatau, executive director, and Sarah Emery Bradley, program coordinator, of the Mothers’ Milk Bank at Austin for reviewing this paper. The author also thanks the staff and Board of the Mothers’ Milk Bank at Austin for their invaluable support and resources. Lastly, human donor milk banks would not exist
Human Milk Banking in the United States
without mothers who give countless time and energy to the pumping and storing of milk for recipients—many, many thanks to all of you!
References 1. Human Milk Banking Association of North America (HMBANA) general information. Available at http://www.Hmbana.org/general-info. htm [accessed 2/15/2005] 2. Golden J: A social history of wet nursing in America: from breast to bottle. Columbus, Ohio State University Press, 2001 3. Greer F: Feeding the premature infant in the 20th century. J Nutr 131:426S – 430S, 2001 4. Jones F: The history of North American donor milk banking: one hundred years of progress. J Hum Lact 19:313 – 318, 2003 5. Tully MR, Lockhart-Borman L, Updegrove K: Stories of success: the use of donor milk is increasing in North America. J Hum Lact 20: 75 – 77, 2004 6. Human Milk Banking Association of North America (HMBANA) milk bank locations. Available at http://www.hmbana.org/locations.htm [accessed 2/11/2005] 7. Huget J: Entrepreneur plans network of breast milk banks [written September 4, 2001, for Washington Post, page HE01]. Available at http:// www.mercola.com/2001/sep/15/breast _ milk _ banks.htm [accessed 2/11/ 2005] 8. Erwin J: Mother’s milk promoting breastfeeding in Texas; July 22, 1999. Available at http://www.nurseweek.com/features/99-7/friendly.html [accessed 2/15/2005] 9. American Association of Blood Banks: Standards for blood banks and transfusion services. Arlington (VA), American Association of Blood Banks, 1997 10. May J: Human milk—tables of the antimicrobial factors and microbiological contaminants relevant to human milk banking. LaTrobe University Department of Microbiology. Available at www.latrobe.edu. au/microbiology/milk [accessed March 4, 2005]
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11. Wight N: Commentary: donor human milk for preterm infants. J Perinatol 21:249 – 254, 2001 12. Novak F, et al: Methicillin-resistant Staphylococcus aureus in human milk. Mem Inst Oswaldo Cruz (Rio de Janeiro) 95:29 – 33, 2000 13. Todar K: The Genus Bacillus, in Todar K (ed): Todar’s online textbook of bacteriology. University of Wisconsin-Madison, Department of Bacteriology. Available at http://textbookofbacteriology.net/Bacillus. html [accessed 2/11/2005] 14. Agostoni C, et al: Long-chain polyunsaturated fatty acid concentrations in human hindmilk are constant throughout twelve months of lactation, in Newburg DS, (ed): Bioactive components of human milk, International Society for Research on Human Milk and Lactation Interna. New York, Kluwer Academic Publishers, 2001 15. Ford JE, Law BA, Marshall VM, et al: Influence of the heat treatment of human milk on some of its protective constituents. J Pediatr 90:29 – 35, 1977 16. Lepri L, et al: Effect of pasteurization and storage on some components of pooled human milk. J Chromatogr B Biomed Sci Appl 704:1 – 10, 1997 17. Henderson TR, Fay TN, Hamosh M: Effect of pasteurization on long chain polyunsaturated fatty acid levels and enzyme activities of human milk. J Pediatr 132:876 – 878, 1998 18. Tully DB, Jones F, Tully MR: Donor milk: what’s in it and what’s not. J Hum Lact 17:152 – 155, 2001 19. McPherson RJ, Wagner CL: The effect of pasteurization on transforming growth factor alpha and transforming growth factor beta 2 concentrations in human milk. Adv Exp Med Biol 501:559 – 566, 2001 20. Liebhaber M, et al: Alterations of lymphocytes and of antibody content of human milk after processing. J Pediatr 91:897 – 900, 1977 21. Lawrence RA: Storage of human milk and the influence of procedures on immunological components of human milk. Acta Paediatr Suppl 88:14 – 18, 1999 22. Evans TJ, et al: Effect of storage and heat on antimicrobial proteins in human milk. Arch Dis Child 53:239 – 241, 1978 23. Arnold LD: The cost-effectiveness of using banked donor milk in the neonatal intensive care unit: prevention of necrotizing enterocolitis. J Hum Lact 18:172 – 177, 2002
Abstract Approximately 30 milk banks existed in the early 1980s in the United States, whereas seven banks currently exist in the United States and one in Canada. Recently, there has been a resurgence of interest in human milk banks as evidenced by the number of institutions in various stages of developing new human milk banks. During 2003, North American milk banks processed more than 500, 000 ounces of donated human milk that was used in individuals with a variety of diagnoses. Human milk banking continues to evolve and grow as new information on the nutritional composition of milk and the needs of the neonate, as well as the benefits of donor human milk for the fragile infant, are anticipated, as discussed by Arnold [Arnold LD: The cost-effectiveness of using banked donor milk in the neonatal intensive care unit: prevention of necrotizing enterocolitis. J Hum Lact 18:172–177, 2002]. Based on the number of premature infants in North America, the number of potential recipients is not likely to diminish anytime soon. The expanding numbers and capacity of existing milk banks can meet this need. As the public and neonatal community awareness of donor human milk benefits and safety grows, the demand for this precious commodity may increase. This article provides an overview of human milk banking and describes in more detail the specific practices of the human milk bank in Austin, Texas. n 2005 Elsevier Inc. All rights reserved.
From the Mothers’ Milk Bank at Austin, Austin, TX. Address reprint requests to Kim Updegrove, MSN, RN, CNM, MPH, Mothers’ Milk Bank at Austin, 900 East 30th Street, Suite 214, Austin, TX 78705. n 2005 Elsevier Inc. All rights reserved. 1527-3369/05/0501-0003$30.00/0 doi:10.1053/j.nainr.2005.02.005
Human Milk Banking in the United States By Kim Updegrove, MSN, RN, CNM, MPH
M
eeting someone new and asking about their work can either lead to a very interesting discussion or a dead end in the conversation. Certain professions startle people. Funeral directors and dentists understand this. As a certified nurse midwife, this writer has learned to anticipate a mixed reaction to my job title; however, this response pales in comparison to the reaction I get when I say I am the clinical coordinator of the Mother’s Milk Bank at Austin (MMBA) in Austin, Texas. The MMBA does not have automated teller machines or carry much cash; instead, it stores and processes human milk collected from screened donors and dispenses it to medically needy individuals or to hospitals for use in their institutions. North American human milk banks processed more than 500, 000 ounces of donated human breast milk in 2003 (Fig 1). In 2003, donor human milk was used for a variety of diagnoses in the United States and Canada that included medical treatment, prevention of disease, and nutritional support (Table 1). This article will provide a general overview of milk banking and a more detailed look at specific practices of the MMBA.
Human Milk Bank
A
ccording to the Human Milk Banking Association of North America (HMBANA), ba donor human milk bank is a service established for the purpose of collecting, screening, processing, storing, and distributing donated human milk to meet the specific needs of individuals for whom human milk is prescribed by health care providers who are licensed to prescribe.Q1 HMBANA is the professional association for human milk banks in Canada, Mexico, and the United States and was founded in 1985. The purposes of HMBANA are listed in Table 2. Milk banking is not a new concept; historically, most babies were fed human milk, either their own mother’s milk or donated human milk from a wet nurse. The first of many milk banks in North America was founded in Boston, Massachusetts, as a home for lactating women who were paid to wet-nurse needy infants.2 The development and successful marketing of bovine formulas changed this situation in the 1900s and, along with other factors, were influential in altering the expectation that an infant would receive human milk regardless of its mother’s ability to provide the milk herself.2– 4 Hospital budget crises, decreased breastfeeding rates, fears of viruses, and other illnesses potentially spread through breast milk led to multiple closings of the banks.4 Human milk banks are now experiencing a resurgence of interest and resources.5 Although approximately 30 milk banks existed in the early 1980s in the United States, only seven banks currently exist in the United States and one in Canada (Fig 2).6 A new milk bank category, which is also under HMBANA Newborn and Infant Nursing Reviews, Vol 5, No 1 (March), 2005: pp 27–33
27
28
Kim Updegrove
,C al if D en ve r, C ol Io o w a C ity ,I ow a R al ei gh ,N C Au Va st nc in ou ,T ve ex rB C ,C an ad a
Jo Sa n
Table 2. Purposes of HMBANA1 Purpose
200,000 180,000 160,000 140,000 120,000 100,000 80,000 60,000 40,000 20,000 0 se
Ounces
Milk Banks of HMBANA, 2003 Dispensed Ounces
! Develop guidelines for milk banking in North America ! Provide a forum for information sharing among those in the field of donor milk banking ! Provide information to the medical community regarding use of donor milk ! Encourage research into the unique therapeutic and nutritive properties of human milk ! Act as a liaison between member banks and governmental agencies ! Facilitate communication among member banks ! Facilitate the establishment of new donor milk banks
Milk Bank
Fig 1. Dispensed human milk from milk banks in the United States and Canada.
guidance, is emerging—the developing milk bank.7 The developing milk bank refers to those organizations that have taken a number of steps toward organizing efforts to open a new milk bank but have not yet begun to process and dispense human milk. Many hospitals operate what are called bmother’s own milkQ banks.8 Mother’s own milk banks consist of services within hospitals in which mothers can express breast milk for their hospitalized infants and store it for future use by their own infant. This milk is not processed in any way, and it is not shared with other infants.
Donors
H
uman milk donors are healthy lactating women who choose to share their excess breast milk. Donors
Table 1. Uses of Banked Human Milk in 20031 Medical and Therapeutic
Nutritional
Short gut syndrome
Prematurity
Infectious diseases Postsurgical healing
Failure to thrive Malabsorption syndromes Feeding intolerance
Immunologic diseases Renal failure Inborn errors of metabolism
Preventive Health Necrotizing enterocolitis AIDS Crohn disease Colitis
must take minimal or no medications and no herbal products. Human milk supply may naturally be higher than required for the donor’s infant or can be stimulated through increased breast pumping. A lactating mother of a deceased infant may contribute milk that was intended for her infant. The decision to donate human milk requires a sense of commitment to the community. Donors are not paid, but they do have the satisfaction of knowing that they have helped others. This sense of satisfaction is apparent in the following quotation from a donor mother. bI gave birth to twins—a boy and a girl—in the summer of 2002. In spite of carrying them to term, my daughter ended up in neonatal intensive care unit (NICU) for several days. The first time I saw her lying there in the Isolette with all those wires sticking out of her and her ferocious little frown really broke my heart. I was afraid to touch her. I was quickly brought to reality though, by looking around at the other babies and mothers in NICU. My tiny, rosy, little 4-pound 11-ounce daughter was a giant compared with her preterm neighbors. And my 8-day stay, although it seemed like forever to me, was nothing compared with that of those tired parents who were making the trek back and forth to NICU for weeks on end. When I learned about the milk bank, I jumped at the chance to donate breast milk. I was so happy to give something so meaningful to all those tiny babies in NICU. I felt privileged to have gotten a glimpse of their fragile little lives, but also so grateful that it was only a glimpse. My daughter went home and is now an energetic and thriving toddler. Maybe my milk helped one of those other tiny ones get home to a more normal life a bit sooner. I am grateful to the milk bank for the opportunity to help other families in this way.Q
Donors are self-selected—they determine their ability and interest in sharing their milk. They may not have known about donor milk banking before feeding their own infant; however, once informed, they like the idea. Mothers find out about donating human milk in much the same way they find out about car seats or any other baby-related topic—they read about it in a parenting magazine; hear about it from a prenatal care provider or
Human Milk Banking in the United States
29
Fig 2. Locations of established and developing milk banks in North America. Used with permission from HMBANA. Available at: http://www.hmbana.org.
childbirth educator or during breastfeeding preparation classes, hospital staff, family, or friends; or read about it on the Internet. Word of mouth is powerful when promoting donor milk banking, and the success of milk banks is testimony to this. A total of 938 donors were screened by North American milk banks in 2003 (M. Tagge, personal communication, January 2, 2005). The donor screening process follows HMBANA guidelines and is very similar to human blood bank guidelines.9 Based on scientific research, these guidelines incorporate knowledge of transmission of viruses and bacteria through body fluids, the transference of medications and herbs through breast milk, and the risks of certain lifestyles for various diseases. Specific screening processes across the milk banks may differ slightly, but each meets the requirements of HMBANA.
Donor Screening
A
t MMBA, the screening process begins when a lactating mother calls the office and asks about donating her milk. A short conversation follows in which questions regarding the mother’s and baby’s health, her lifestyle, and maternal medical issues are explored. This usually leads to a preliminary decision about the appropriateness of the individual as a milk donor. Donors are permitted to use a limited number of medications that include hypothyroid medications, insulin, and progestinonly birth control methods. Herbal use is not accepted because of a lack of clinical data on the risks of these
substances to the nursing infant. Donors frequently are taking mothers’ milk tea (a beverage made from a combination of fennel, anise, fenugreek, coriander seed, and blessed thistle herb) or domperidone to stimulate milk supply; however, these substances have not been studied for their effects on the neonate, especially the premature infant. Donor mothers must agree to stop using these herbs and cannot donate until after the specific clearance time has passed. After passing the preliminary phone screening, a packet of information is mailed to the approved donor. The information describes how to pump and store milk in acceptable containers for donation and explains the required blood tests—human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotrophic virus, hepatitis B, hepatitis C, and syphilis. Medical release forms that give MMBA permission to contact the infant’s care provider and the prenatal care provider for signed statements about the health of the donor and her baby are also included in the packet. Although the blood tests required may repeat some of the tests that were already done during the prenatal period, the second set of tests provides an updated medical picture of the donor and allows for comparison with the earlier blood work. The blood work requirement also emphasizes the strict control over the quality of the donated milk. Once all paperwork is returned and the blood work obtained, this information is reviewed by the clinical coordinator, and the donor is either approved, denied, or asked to answer more questions before a decision can be made. Donor exclusion criteria are defined by HMBANA and include regular use of medication (other than the previ-
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Kim Updegrove
208C. Each donor’s milk is identified by a unique donor identification number that allows a staff member to verify that this is a screened donor. The milk is kept in the freezer at these depots until a volunteer or milk bank staff member can transport it to the milk bank.
Milk Processing
D
Fig 3. Donor mother reassembling a breast pump after cleaning. Used with permission from HMBANA. Available at: http:// www.hmbana.org.
ously mentioned acceptable drugs) or herbal use, any positive serum test on required blood tests, risk factors for HIV or hepatitis, use of illegal drugs, use of nicotine products, regular alcohol intake (12 hours must lapse before collection of human milk following any alcohol consumption), or travel to the United Kingdom for more than 3 months between 1980 and 1996 or more than 5 years at any time.1
onor milk undergoes pasteurization at the MMBA. Milk from approved donors is selected twice per week for this process. Once selected for a specific day of pasteurization, the milk is thawed, poured into flasks (Fig 4), and mixed carefully to homogenize any solid components (eg, fat). A sample is taken for microbiologic screening and is plated for identification and counting of bacterial colonies. Pasteurization eliminates most skin and some gastrointestinal flora that are present in human milk.10,11 Human milk that tests positive for certain bacteria including Staphylococcus aureus, methicillinresistant S aureus, and any of the bacillus species are discarded and not subjected to further processing. Although the pasteurization technique kills S aureus and methicillin-resistant S aureus, these microorganisms can release an endotoxin or enterotoxin that could, theoretically, cause gastrointestinal problems for the recipient infant. Enterotoxins are heat-resistant, so pasteurization may not render them harmless.12 Because some bacteria are heatloving organisms, a second culture is obtained after the heating process. The bacillus species are one such organism and will grow during pasteurization if the spores are active.13 The second culture also serves to verify that no microorganisms were introduced during the pouring and pasteurization process. No bacteria, pathogenic or not, are
Milk Donation
D
onor milk can be expressed manually or through use of a breast pump. Donors must adhere to pumpcleaning instructions and advice about milk storage to limit contamination by pathogens. Modern breast pumps tend to easily assemble and disassemble for cleaning (Fig 3). MMBA requires the donor to bring in a minimum of 100 ounces of expressed milk. Donors may deliver the expressed milk to the milk bank itself or to one of a number of depots or collection sites in her area. Milk collection sites are generally located within medical facilities or on the grounds of a medical facility where at least one staff member has been trained on proper storage of donor milk. The milk is placed in an acceptable freezer within the facility maintained at a temperature of
Fig 4. Donor milk in flasks waiting for target pooling. Used with permission from HMBANA. Available at: http:// www.hmbana.org.
Human Milk Banking in the United States
31
Fig 5. MilkoScan FT120. Used with permission from HMBANA. Available at: http://www.hmbana.org. Fig 7. Nutritional labeling. Used with permission from HMBANA. Available at: http://www.hmbana.org.
tolerated in the postpasteurization culture. Any positive postpasteurization colony leads to the discarding of that donor’s milk. A second sample is taken from the thawed donor’s milk before pasteurization for nutritional analysis. This is not a requirement of HMBANA guidelines, but rather is done because human milk has a wide range of nutrients especially with regard to fat.14 MMBA has worked with the US Department of Agriculture dairy laboratory in Carrolton, Texas, and the manufacturer of the MilkoScan FT120 (Foss North American, Inc; Eden Prairie, MN) to develop a process for conducting nutritional evaluation of human milk. The MilkoScan FT120 is a device used by the dairy industry to evaluate dairy products using infrared technology (Fig 5). Both Foss and the US Department of Agriculture continue to work with the MMBA in evaluating the accuracy of nutritional information No. of oz: August to December 31, 2003 (Total = 48,892) 30000
Number of ounces
25000
obtained. After recalibrating the machine to evaluate human milk, the MilkoScan is used to target pooled donor milk. Target pooling is a process in which the milk from specific donors is mixed together in certain volumes to ensure a minimum caloric and protein value for the milk. This process maximizes the usability of donor breast milk for hospitalized infants. Donor human milk is dispensed for hospital use if it is z19.5 kcal/oz (z81.9 kJ/oz). Rounding to the nearest tenth degree, the milk is labeled as 20 kcal/oz (84 kJ/oz), 22 kcal/oz (92.4 kJ/oz), or 24 kcal/ oz (100.8 kJ/oz) for hospitals. Milk that is less than 19.5 kcal/oz (81.9 kJ/oz) but greater than 16.5 kcal/oz (69.3 kJ/ oz) is used for outpatient recipients. Milk that is less than 16.5 kcal/oz (69.3 kJ/oz) is discarded. Typically, two to three donor milks are included in a pool. Fig 6 describes target pool outcomes during the period from August to December 2003. After target pooling, another sample is taken and tested for nutritional content. This sample is used to verify the prediction made from individual donor milk samples. It also provides the nutritional data printed on the labels of bottles (Fig 7).
20000 15000
Milk Pasteurization
10000
D
5000 0 No. of oz unusable (0.9%)
Outcome
No. of oz No. of oz No. of oz No. of oz outpatient 20 Kcal/oz 22 Kcal/oz 24 Kcal/oz (under 19.5) (19.5 to 21.4) (21.5 to 23.4) (23.5 to 25.4) (29%) (58%) (12%) (0.8%)
Fig 6. Target pool outcomes from August to December 2003.
onor human milk has come a long way since the days of wet nursing and sharing of raw milk among babies. The potential of maternal viral shedding led to the standard practice of pasteurizing donor milk. Currently, HMBANA guidelines call for the use of Holder pasteurization, which is a long-term low-temperature technique.15 During Holder pasteurization, the milk is placed in a shaking water bath and heated to 62.58C for 30 minutes (Fig 8). The critical nutritional components of fat, protein,
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Kim Updegrove
children or adults with a variety of chronic and acute disorders. The use of human donor milk in adults and older children is not well researched at this time; however, theoretically and anecdotally, it may help those with immune disorders, allergic disorders, or intestinal diseases.
Cost
A Fig 8. Holder pasteurization. Used with permission from HMBANA. Available at: http://www.hmbana.org.
and carbohydrate are stable throughout this process.16–19 Immune factors are minimally compromised, but partial or complete losses of B-cell and T-cell components of the milk, lymphocytes, and specific antibodies such as immunoglobulin A are lost during pasteurization.15,20–22 Donor human milk is pasteurized in the bottles in which the milk will be dispensed. Following pasteurization, the milk is quickly cooled in an ice bath and frozen for dispensing. One bottle from each batch within a pool is taken after pasteurization, and another sample is taken and sent to a microbiology laboratory to check for pathogens or other bacterial growth. A sample is also taken to recheck the nutritional content. Aseptic technique is used throughout the processing of donor human milk.
Dispensing Milk
H
ospitals with a need for donor human milk call the nearest milk bank and place an order for their anticipated volume need. The milk is delivered locally by volunteers or milk bank staff. Milk going to nonlocal hospitals is packaged with dry ice and shipped overnight or delivered by courier. Once at the target NICU, the donor milk is kept frozen until it is needed. Thawing and other handling of donor breast milk are the same as the practices used with a mother’s own milk for her baby. Outpatients may also use donor human milk. In these cases, a health care provider supplies the milk bank with a prescription for donor milk and a brief letter of medical necessity. The milk is then delivered to an individual household the same way it is delivered to hospitals. Most outpatient recipients of donor milk are infants who were not able to be weaned from donor human milk by the time of discharge or for whom weaning was not medically advisable. Occasionally, donor milk is prescribed for older
s previously stated, donors of human milk are not paid for their breast milk. Because the processing and screening of donor milk are costly, these costs are reflected back to the hospitals when they order donor human milk. Although the price per bottle may differ slightly across the banks, the average cost is approximately US$3 to US$3.50 per ounce. Hospitals are also responsible for shipping costs. Outpatients also pay a processing fee for donor milk. In some cases, private insurance companies will cover this cost; in others, the family is responsible. Although Medicaid requirements differ by state, many state Medicaid programs will cover some portion of the cost of donor milk if the relevance of the milk to the infant’s diagnosis is approved. Milk banks also provide milk to many outpatients who do not have private insurance and who cannot pay for the milk. Grants and individual donations help to make up for these losses to the banks.
Conclusion
H
uman milk banking continues to evolve and grow, as new and greater information on the nutritional composition of milk and the needs of the neonate, as well as the specific benefits of donor human milk for the fragile infant, are anticipated.23 Based on the number of premature infants in North America, the number of potential recipients is not likely to diminish anytime soon, despite our best efforts to improve the breastfeeding rate. The expanding numbers and capacity of existing milk banks can meet this need. As the public and neonatal community awareness of donor human milk benefits and safety grows, the demand for this precious commodity may increase.
Acknowledgment
T
he author thanks Gretchen Flatau, executive director, and Sarah Emery Bradley, program coordinator, of the Mothers’ Milk Bank at Austin for reviewing this paper. The author also thanks the staff and Board of the Mothers’ Milk Bank at Austin for their invaluable support and resources. Lastly, human donor milk banks would not exist
Human Milk Banking in the United States
without mothers who give countless time and energy to the pumping and storing of milk for recipients—many, many thanks to all of you!
References 1. Human Milk Banking Association of North America (HMBANA) general information. Available at http://www.Hmbana.org/general-info. htm [accessed 2/15/2005] 2. Golden J: A social history of wet nursing in America: from breast to bottle. Columbus, Ohio State University Press, 2001 3. Greer F: Feeding the premature infant in the 20th century. J Nutr 131:426S – 430S, 2001 4. Jones F: The history of North American donor milk banking: one hundred years of progress. J Hum Lact 19:313 – 318, 2003 5. Tully MR, Lockhart-Borman L, Updegrove K: Stories of success: the use of donor milk is increasing in North America. J Hum Lact 20: 75 – 77, 2004 6. Human Milk Banking Association of North America (HMBANA) milk bank locations. Available at http://www.hmbana.org/locations.htm [accessed 2/11/2005] 7. Huget J: Entrepreneur plans network of breast milk banks [written September 4, 2001, for Washington Post, page HE01]. Available at http:// www.mercola.com/2001/sep/15/breast _ milk _ banks.htm [accessed 2/11/ 2005] 8. Erwin J: Mother’s milk promoting breastfeeding in Texas; July 22, 1999. Available at http://www.nurseweek.com/features/99-7/friendly.html [accessed 2/15/2005] 9. American Association of Blood Banks: Standards for blood banks and transfusion services. Arlington (VA), American Association of Blood Banks, 1997 10. May J: Human milk—tables of the antimicrobial factors and microbiological contaminants relevant to human milk banking. LaTrobe University Department of Microbiology. Available at www.latrobe.edu. au/microbiology/milk [accessed March 4, 2005]
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11. Wight N: Commentary: donor human milk for preterm infants. J Perinatol 21:249 – 254, 2001 12. Novak F, et al: Methicillin-resistant Staphylococcus aureus in human milk. Mem Inst Oswaldo Cruz (Rio de Janeiro) 95:29 – 33, 2000 13. Todar K: The Genus Bacillus, in Todar K (ed): Todar’s online textbook of bacteriology. University of Wisconsin-Madison, Department of Bacteriology. Available at http://textbookofbacteriology.net/Bacillus. html [accessed 2/11/2005] 14. Agostoni C, et al: Long-chain polyunsaturated fatty acid concentrations in human hindmilk are constant throughout twelve months of lactation, in Newburg DS, (ed): Bioactive components of human milk, International Society for Research on Human Milk and Lactation Interna. New York, Kluwer Academic Publishers, 2001 15. Ford JE, Law BA, Marshall VM, et al: Influence of the heat treatment of human milk on some of its protective constituents. J Pediatr 90:29 – 35, 1977 16. Lepri L, et al: Effect of pasteurization and storage on some components of pooled human milk. J Chromatogr B Biomed Sci Appl 704:1 – 10, 1997 17. Henderson TR, Fay TN, Hamosh M: Effect of pasteurization on long chain polyunsaturated fatty acid levels and enzyme activities of human milk. J Pediatr 132:876 – 878, 1998 18. Tully DB, Jones F, Tully MR: Donor milk: what’s in it and what’s not. J Hum Lact 17:152 – 155, 2001 19. McPherson RJ, Wagner CL: The effect of pasteurization on transforming growth factor alpha and transforming growth factor beta 2 concentrations in human milk. Adv Exp Med Biol 501:559 – 566, 2001 20. Liebhaber M, et al: Alterations of lymphocytes and of antibody content of human milk after processing. J Pediatr 91:897 – 900, 1977 21. Lawrence RA: Storage of human milk and the influence of procedures on immunological components of human milk. Acta Paediatr Suppl 88:14 – 18, 1999 22. Evans TJ, et al: Effect of storage and heat on antimicrobial proteins in human milk. Arch Dis Child 53:239 – 241, 1978 23. Arnold LD: The cost-effectiveness of using banked donor milk in the neonatal intensive care unit: prevention of necrotizing enterocolitis. J Hum Lact 18:172 – 177, 2002