By Student Intern Hannah Van Houten
Pasteurized donor human milk (PDHM) is human breast milk that has been donated to a milk bank, like the Mothers’ Milk Bank of TN. Before it can be distributed to babies in need, PDHM is run through an extensive process to ensure that it is safe. Involved in this process are several organizations, protocols, and steps that must be carefully followed.
HMBANA (Human Milk Banking Association of North America) was founded in 1985 with the goal to mobilize the healing power of donor milk by accrediting nonprofit milk banks in the U.S and Canada, as well as setting international guidelines for pasteurized donor human milk.
It all started when artificial milk was linked negatively to infant mortality and morbidity. In response to this, 2 physicians started the first U.S human milk ‘bank’, in Boston. This first milk bank provided a home for lactating mothers and their own infants, where they could also act as wet nurses for babies in need. These women were screened for diseases like tuberculosis and syphilis to ensure the milk was safe. After a short time, this first milk bank evolved closer to what we now know as a milk bank, with donors providing milk and no longer offering wet nursing. It’s important to note that wet nursing and a practice called milk-sharing (sharing of breast milk without involving a milk bank, and not pasteurizing the milk) are still practiced today, and it is not endorsed, as it does not ensure the safety of the milk.
1943- In 1943, an organization called the American Academy of Pediatrics (AAP) Committee on Mothers’ Milk published guidelines for milk bank operations. These guidelines included proper methods for collecting, processing, storing, and dispensing donor milk. Unfortunately, after World War II, the interest in donor milk started to decline, as well as breastfeeding in Canada and the U.S. During this time formula use continued to be popular.
The 1970s- In the 1970s there was a revival in donor milk banking, due to the increase in breastfeeding among new mothers and advances in neonatology, which led to improving survival rates for sick and premature infants. With this increase, medical facilities and volunteer organizations for breastfeeding women created distributing banks in communities across North America, and some hospitals set up in-house banks to meet the needs of babies in the neonatal intensive care units (NICU), who did not have access to mother's own milk.
The 1980s- By the 1980s there were 23 active milk banks in Canada and 30 in the United States! The AAP published an updated policy statement where they supported human milk banks, and it was followed by a similar statement from the Canadian Pediatric Society (CPS) in 1985.
Unfortunately, even with the growing interest in human milk for human babies, safety concerns started to creep in in the 1980s due to the concern for transmission of viruses, like HIV and hepatitis. These concerns negatively affected donor milk banks. Combined with economic factors and the marketing of preterm infant formulas, there was a closure of most milk banks.
This is where the official formation of HMBANA comes in. They supported the remaining milk banks and began developing the screening and processing guidelines that ensure the safety of donor milk. Even with this support, by 2000, there were still only 5 HMBANA banks operating in North America.
The 2000s- Since the 2000s there has been an increase in the number of milk banks. This is due to the increase in scientific evidence for the use of pasteurizing and freezing human milk to kill viruses and bacteria, as well as its benefit for babies. Throughout the early 2000s, there were numerous publications from respected organizations, promoting donor human milk. These organizations included the World Health Assembly, the American Academy of Family Physicians, and the CPS.
The American Academy of Pediatrics published a policy statement regarding breastfeeding in the early 2000s (16), and the Academy of Breastfeeding Medicine was in its early years of existence (17).
In 2010 the U.S Food and Drug Administration (FDA) endorsed donor milk banking, and a statement in 2012 from AAP recommended donor milk when mothers’ own milk is not available.
Since then, human milk banking has seen some ups and downs, especially the recent COVID_19 pandemic, but despite this, they have continued to thrive! HMBANA now has 31 Member Milk Banks in Canada and the United States combined.
HMBANA Member Milk Banks
Mothers’ Milk Bank of TN (MMBTN) is one of HMBANA’s 31 Member Milk Banks that help mothers across North America donate their extra breast milk to be prescribed to infants in need. This means that MMBTN is certified by HMBANA and required to pasteurize their milk according to the quality standards set by HMBANA. By being a member of HMBANA, hospitals receiving milk from MMBTN can be assured it’s safe for babies in need. The efforts of HMBANA ensure that the process of donating, pasteurizing, and giving PDHM to infants is evidence-based and clinically sound. They advocate for donor milk as a universal standard of care when Mothers Own Milk (MOM) and Mothers’ Own Pumped Milk, is not an option. HMBANA strongly believes in a world where all infants have access to human milk through supporting breastfeeding and the use of donor human milk. MMBTN shares those beliefs and strives to serve the infants of Tennessee that, without safe human milk, may not survive. (1)(2)
Another organization important to PDHM is TIPQC or The Tennessee Initiative for Perinatal Quality Care. Since the beginning of TIPQC in 2007, the Tennessee Initiative for Perinatal Quality Care has promoted collaborative statewide inter-institutional projects. These projects are designed to improve perinatal outcomes for both the mothers and babies of Tennessee.
TIPQC acquires funds through a grant awarded by the State of Tennessee through a program called TennCare. There are also federal additional matching funds through the Department of Health.
The mission of TIPQC since the beginning has been to improve health outcomes for newborns and mothers throughout Tennessee. ** TIPQC does this by engaging key stakeholders in a perinatal quality collaborative that will help to show opportunities to optimize birth outcomes, as well as implement data-driven provider and community-based performance improvement initiatives.
TIPQC goals include:
· Establishing a statewide storehouse of prenatal data for quality improvement initiatives
· Foster state-wide quality improvement initiatives to lower maternal and infant mortality and morbidity and improve outcomes
· To increase knowledge of the impact of implicit bias and systemic racism and their contributions to disparities in maternal and infant outcomes
· To promote system changes by provider organizations to increase the use of evidence-based clinical practices to eliminate disparities in access, treatment, and outcomes of mothers and their infants.
They focus on many projects surrounding mothers and infants, and several that are related to breastfeeding and human milk. TIPQC also recruited hospitals all over the state of TN to work together on projects that are voted on. They also recognize those hospitals that can show improvements in Perinatal Care as a result of the projects.
In 2009 they started a project titled, Human Milk for the NICU, and in 2010 they added a breastfeeding promotion project. The Human Milk for the NICU project was created because of complications linked with the initiation of enteral feeds, like tube feeding or oral feedings, in very low birth weight babies, and all NICU babies were widely recognized as a source of excess morbidity, mortality, costs, and length of stay in the NICU.
Numerous reports documented the effectiveness of human breast milk in reducing NICU feeding morbidity The project was focused on providing human breast milk to NICU babies in need, much like MMBTN strives to provide PDHM to babies in need. This project was one that initially led to the interest in starting a Milk Bank in Tennessee because participating hospitals were having to order milk from outside of TN. (3)(4)(5)
Both HMBANA and TIPQC play key roles in the Mothers’ Milk Bank of TN, from its inception, to how it functions now, on a day-to-day basis. To better understand MMBTN, it is important to understand these two other organizations as well.
The infant mortality rate of the United States in 2017 was 5.8 deaths per 1,000 live births ranking it 55th in the world for highest infant mortality. Tennessee had a higher infant mortality rate than that of the United States averaging 7.2 deaths per 1,000 live births in 2018. This translated to one infant death every 15 hours in the states- ranking Tennessee 11th in the nation for the highest rate of infant mortality. In Tennessee and across the United States, non-Hispanic black infants are at roughly twice the risk of infant mortality than white infants. ( TN Department of Health)(10)
The Screening Process
Before they can donate, all donor mothers are required to undergo screening and approval. Donor qualifications are based on best practices and clinical data. These qualifications are also updated continuously to reflect new data.
Each donor is screened with a standard set of questions that are designed to determine whether they can donate their milk. The screening process includes assessments of the donor’s baby’s health, to ensure there are no diseases or infections present. Questions regarding the donor’s known health and medical risks will be asked, as well as current medications, vaccines, or herbals from licensed care providers, or a provider certified to practice in their state/province. If medical records can be obtained, it is usually asked for the donor to provide them. Screeners will also speak with the baby’s care provider and have them confirm the health of the baby.
Donors are also screened serologically, through a blood test, for HIV-1 and -2, HTLV-1 and -2 (Human T-cell Lymphotropic virus), hepatitis C, hepatitis B, and syphilis. Two people need to sign off on a donor’s application to be a breast milk donor. One of these two must be a licensed health care provider with credentials, for example, a nurse, physician’s assistant, or physician.
During their time as a donor, they must communicate with the milk bank regarding changes in their health, medical, or lifestyle status, as well as the status of anyone in their household.
Once a donor is approved, they will be notified, and they can begin donating their breast milk to a milk bank like MMBTN.
The Pasteurizing Process
HMBANA Member Milk Banks, like MMBTN, follow a carefully standardized protocol for pasteurizing the breastmilk donated. American milk banks are regulated and inspected by the Food in Drug Administration (FDA) and local health departments, as well as comply with the Food Safety Modernization Act (FSMA). All of this, along with the protocol and procedures put in place by HMBANA, ensures the milk sent to babies in need is safe.
Receiving Donor Milk
When donated, the breastmilk is frozen and unpasteurized and will remain that way until it is ready to be pasteurized. The milk is traced to a specific donor and records are maintained of all milk, even milk that is discarded. Each donation is inspected and held to the quality standards from HMBANA. A record of the condition and estimated volume is collected, as well as any shipping records, and receiving date.
Milk cannot be donated if it has been heat-treated in any way ( warming, scalding, boiling, or thawed after freezing). Each donor is asked about the length of time the milk was refrigerated, prior to freezing, and the milk can’t be accepted if that time exceeds 96 hours. Milk expires 12 months after the pump date and cannot be accepted at a milk bank for donation purposes.
Pasteurizing the milk ensures that any bacteria or viruses are removed. It is an important step in the PDHM process and must be carefully followed. To begin the pasteurization process, the breastmilk is allowed to thaw either in a refrigerator or outside a refrigerator, as long as it is prevented from being altered or contaminated. It must be kept out of sunlight and away from any heat source.
Thawed milk is then filtered, using a food-grade sieve, or filter, to remove any foreign objects before it moves on to the bottling stage. Samples of the milk from each mother are taken for bacteriological testing. This sample is sent to a lab to confirm the safety of that batch of milk. The next step is the pooling process, which is conducted under clean conditions. In this step, the breastmilk is thoroughly mixed to ensure an even distribution of nutrients the milk contains.
The pooled milk is stored either in glass or food-grade plastic that meets the FDA requirements for both freezing and heating temperatures before it is transferred to clean bottles. Each bottle is filled, leaving enough air space for expansion during heating and freezing, and all bottles are filled with the same amount. Bottles are carefully examined, and each one is closed tightly to prevent leakage, tamper-evident lids are added.
Once the bottles are prepared, they can be pasteurized. The bottles of breastmilk are submerged in a pre-heated water bath, and a temperature probe is attached to a ‘control’ bottle of milk. This control bottle is for quality assurance purposes and allows for careful monitoring of temperature. The standard of pasteurization is for the temperature of the milk to reach 62.5°C for 30 full minutes, and to ensure quality, a temperature of 64.5°C is never exceeded. If a batch of milk fails this, it will be discarded.
After the milk is removed from the water bath, it is rapidly chilled in an ice bath. Once chilled, the bottles of milk are labeled with the name of the milk bank, a batch number, expiration date, volume, and the words, “pasteurized donor human milk”. The expiration date is the date 1 year from the earliest pumping date of the pooled milk.
The pasteurized milk is then immediately transferred to a holding freezer. Each batch of milk is quarantined while one bottle from the batch is sent out to a third-party laboratory to be cultured. Only batches where the cultures come back negative are transferred into a freezer where they will remain until shipped to hospitals.
To approve each batch of milk, two individuals, trained and qualified in food safety, will review the pasteurization process, time, and temperature critical limits. They will also review the microbiological test results. Once the batch of milk meets approval in all areas, it can be distributed.
Finally, the pasteurized breastmilk will remain in the freezers of a milk bank before it is properly packaged to be sent or delivered to babies in need. The milk is packaged using a clean technique to prevent any contamination, and it is shipped in special containers that allow the milk to remain frozen during transit, and until it is ready for use. Dry ice is placed in the containers to maintain a freezing temperature, and special temperature strips are used to document that the temperature stays below freezing. (6)
Benefits of PDHM
The benefits of PDHM (Pasteurized Donor Human Milk) are numerous, and increasingly are being recognized and used to help care for infants in need. These benefits range from easier digestion to decreasing rates of disease, as well as morbidity in young infants. Many babies, especially those born prematurely, face difficulty in their first few months. Often these babies have a low birth weight, which puts them at a higher risk for many diseases and conditions. If Mother’s Own Milk is not available to these babies in any form, those difficulties can become worse. Thankfully, PDHM can be the answer to helping these babies survive. (7)(8)(9)
The many benefits of PDHM include:
· Human milk is easier for babies to digest, versus infant formulas
· Lowers the risk of abdominal issues
· Feeding on PDHM often means infants need less or no IV feedings.
· Feedings are easier, especially for babies with necrotizing enterocolitis (NEC). NEC can be difficult, and Neonatologists will sometimes stop and start feedings if the baby’s abdomen becomes distended or swollen.
· Lowers rates of necrotizing enterocolitis (NEC).
o What is NEC? Necrotizing enterocolitis is a common disease of the intestinal tract. This disease causes the tissue lining the intestine to become inflamed, die, and even shed away. The condition typically affects infants who are born preterm or who are already sick, and it usually occurs before the newborn leaves the hospital. (11)
· Has been linked to decreasing infant morbidity rates
· Lowers risk of late-onset sepsis (LOS)
o What is LOS? Neonatal sepsis is a blood infection that occurs in an infant younger than 90 days old. Early-onset sepsis is seen in the first week of life, whereas late-onset sepsis occurs after 1 week through 3 months of age. Late-onset neonatal sepsis is a common, yet serious problem in preterm infants in neonatal intensive care units, and it can significantly increases preterm infant mortality, as well as the risk of cerebral lesions and neurosensory consequences, including developmental difficulties and cerebral palsy. (12)(13)
· Lowers risk of retinopathy of prematurity (ROP)
o What is ROP? Retinopathy of prematurity is a disease of the eye in some premature babies. Premature refers to babies born before 37 weeks, as opposed to a full-term pregnancy at about 38–42 weeks. Babies born before 31 weeks are at the highest risk for ROP, it is a problem that affects the tissue at the back of the eye called the retina. The retina senses light and sends signals to the brain so you can see. This disease is the leading cause of blindness in premature infants. (14)(15), and the data shows it is the leading cause of blindness in infants across the world. (18).
· Benefits neurodevelopment in infants
· Provides a Bioactive Matrix that is not found in infant formulas
For babies all over the world, the best first choice is their mother’s own milk (MOM), or even their mothers’ own pumped breast milk as a second choice. Sadly, for some babies, those choices are not available. In those cases, research has shown and continues to show, that PDHM is the next-best choice for infants in need, such as low-birth-weight infants and infants at risk or suffering from disease, when a mother can’t provide her own milk.
Milk banks like MMBTN are helping to provide PDHM as the next-best choice for babies in need. MMBTN collects donations of human milk from amazing mothers and makes it safe for infants in need through the pasteurization process. Milk Banks like MMBTN strive to provide as much human milk for as many babies as possible because they recognize the benefits that the milk provides.
Dispensing of PDHM
Most donor milk is distributed for clinical use by prescription or hospital purchase order. When donor milk is prescribed, it is for the treatment of various medical conditions, including the ones mentioned above, as well as:
· Premature birth
· Malabsorption Syndrome
· Immunologic Deficiencies
· Postoperative Nutrition
If a milk bank has enough Milk inventory, they may be able to offer milk by prescription for a larger variety of situations, including (6)
· Lacking or inadequate lactation
· Adoption or Surrogacy
· Illness in the mother
· Health risk that the milk from a biological mother might pose to the infant
· Death of the mother
While the Mothers’ Milk Bank of TN strives to help all babies in need in Tennessee, because they are HMBANA’s newest Member Milk Bank, they do not yet have the supply to provide for every baby in need. They focus on NICU babies as their priority but plan to have an outpatient program in the near future, where they can provide PDHM to more babies in need.
1. HMBANA. (n.d.). Milk banking frequent questions. Milk Banking Frequent Questions. Retrieved February 5, 2022, from https://www.hmbana.org/about-us/frequent-questions.html#:~:text=Pasteurized%20donor%20human%20milk%20is%20breast%20milk%20which,and%20all%20donor%20milk%20is%20logged%20and%20monitored.
2. HMBANA. (n.d.). About the Human Milk Banking Association of North America (HMBANA). the Human Milk Banking Association of North America (HMBANA). Retrieved February 5, 2022, from https://www.hmbana.org/about-us/overview.html
3. TIPQC. (n.d.). Tipqc. TIPQC. Retrieved February 5, 2022, from https://tipqc.org/#
4. TIPQC. (2018, May 8). Human milk for the Nicu. TIPQC. Retrieved February 5, 2022, from https://tipqc.org/human-milk-for-the-nicu/
5. UnitedHealthcare and Tennessee Initiative for Perinatal Quality Care Partner to Improve Health of Pregnant Women with Opioid Use Disorder and Opioid-Exposed Newborns. Unitedhealthgroup.com. (2019). Retrieved 29 March 2022, from https://www.unitedhealthgroup.com/newsroom/2019/2019-03-07-tennessee-perinatal-partner.html.
6. Updegrove, K., Festival, J., Hackney, R., Jones, F., Kelly, S., Sakamoto, P., & Vickers, A. (2020). HMBANA Standards for Donor Human Milk Banking. HMBANA.
7. BIDMC. (2014). Pasteurized donor human milk . Beth Israel Deaconess Medical Center. Retrieved February 5, 2022, from https://www.bidmc.org/-/media/files/beth-israel-org/centers-and-departments/neonatology/pasteurizeddonorhumanmilk.pdf
8. Miller J;Tonkin E;Damarell RA;McPhee AJ;Suganuma M;Suganuma H;Middleton PF;Makrides M;Collins CT; (2018). A systematic review and meta-analysis of human milk feeding and morbidity in very low birth weight infants. Nutrients. Retrieved February 5, 2022, from https://pubmed.ncbi.nlm.nih.gov/29857555/
9. Pound, C., Unger, S., & Blair, B. (2020). Pasteurized and unpasteurized donor human milk. Paediatrics & child health. Retrieved February 5, 2022, from https://pubmed.ncbi.nlm.nih.gov/33365109/
10. Infant Mortality. Tn.gov. (2017). Retrieved 29 March 2022, from https://www.tn.gov/health/health-program-areas/tennessee-vital-signs/redirect-tennessee-vital-signs/vital-signs-actions/infant-mortality.html.
11. Necrotizing Enterocolitis (NEC). Nichd.nih.gov. Retrieved 29 March 2022, from https://www.nichd.nih.gov/health/topics/factsheets/nec#:~:text=What%20is%20NEC%3F%20Necrotizing%20enterocolitis%2C%20or%20NEC%2C%20is,occurs%20before%20the%20newborn%20leaves%20the%20hospital.%201.
12. Bentlin, M. R., & de Souza Rugolo, L. M. S. (2010). Late-onset Sepsis: Epidemiology, Evaluation, and Outcome. NeoReviews, 11(8), e426–e435. https://doi.org/10.1542/neo.11-8-e426
13. Neonatal sepsis: MedlinePlus Medical Encyclopedia. (n.d.). Medlineplus.gov. Retrieved March 30, 2022, from https://medlineplus.gov/ency/article/007303.htm#:~:text=Neonatal%20sepsis%20is%20a%20blood%20infection%20that%20occurs
14. What Is Retinopathy of Prematurity (ROP)? (2021, March 10). American Academy of Ophthalmology. https://www.aao.org/eye-health/diseases/what-is-retinopathy-prematurity#:~:text=Retinopathy%20of%20prematurity%20%28ROP%29%20is%20an%20eye%20disease
15. Health Insurance Reform Commission Briefing. (2021). http://jlarc.virginia.gov/pdfs/other/JLARC%20briefing%20to%20HIRC%20on%20PDHM%20mandate.pdf#:~:text=Retinopathy%20of%20prematurity%20Sepsis%20%28including%20meningitis%29%20%EF%82%A7Additional%20research
16. American Academy of Pediatrics. (2012). Breastfeeding and the Use of Human Milk. PEDIATRICS, 129(3), e827–e841. https://doi.org/10.1542/peds.2011-3552
17. ABOUT. (n.d.). Www.bfmed.org. https://www.bfmed.org/about
18. Plus, Disease in Retinopathy of Prematurity: More Than Meets the ICROP? (2017). Asia-Pacific Journal of Ophthalmology. https://doi.org/10.22608/apo.201863