Our Standards | The Nippon Foundation Human Milk Bank

Benefits of using donor milk

The advantage of introducing donor milk is that it provides optimal nutrition without putting too much strain on the bodies of premature infants. In addition, it can reduce the physical and mental burden on mothers who cannot breastfeed. Facilities that have introduced donor milk have realized its high effectiveness, saying that they cannot go back to the days before it.

Advantage

Donor milk enables an infant's tube feeding immediately.

If the mother's milk does not come in after delivery, tube feeding can be started right away without having to wait.

Advantage

Donor milk is the second-best nutrition.

If the amount of breast milk produced by the mother is insufficient, donor milk can provide the additional nutrition necessary for the newborn. Also, if the mother cannot breastfeed due to medical treatment or other reasons, donor milk is often better for the baby than milk formula.

Advantage

Donor milk reduces the risk of necrotizing enterocolitis.

Infants consuming milk formula have a 1.87 times higher risk of suffering from necrotizing enterocolitis than those consuming donor milk (*1). By using donor milk, the risk of necrotizing enterocolitis is reduced.
(*1) Quigley M et al., Cochrane Database of Systematic Reviews, 2019 DOI: 10.1002/14651858.CD002971.pub5

Advantage

Donor milk can shorten the duration of an infant’s intravenous feeding.

If an infant starts tube feeding early, their period of intravenous feeding can be shortened, which minimizes the burden on the infant. (*2)
(*2) Oikawa K et al., Pediatrics International, 2021 DOI: 10.1111/ped.15071

Advantage

Donor milk is effective for babies whose bodies can only accept human milk.

Premature infants with intractable diarrhea or milk allergies cannot accept milk formula. In addition to these cases, donor milk is the best choice when their mothers' milk is insufficient.

Advantage

Donor milk can reduce the physical and psychological burden on the infants' mothers.

In the case of premature birth or cesarean section, various factors and stress can make it difficult for mothers to produce breast milk. Donor milk can lighten the physical burden and mental pressure on them.

Donor Registration Requirements

Must be able to produce more breast milk than what her child needs

No history of treatment for malignancy such as leukemia or lymphoma in the past three years

No blood transfusions or organ transplants

Must meet the no tobacco, alcohol, or drug use requirements

No abnormalities in blood test results at the time of donor registration
(All screening tests for HIV1/2, HTLV-1, hepatitis B, hepatitis C, and syphilis must be negative.)

The Nippon Foundation Human Milk Bank will cover the cost of the test.

Must be able to donate breast milk at least three times (as a rule of thumb, 2 liters or more in total)

Notes (Precautions)

Donors can register only after the completion of their one-month postpartum checkup.
If a large amount of foreign matter is included in the donor milk or if the bacteria count exceeds the standard, The Nippon Foundation Human Milk Bank may contact the donor to improve hygiene when milking and shipping. And, if this situation continues even after the notification, the organization may terminate the donor’s registration.
The criteria for donor milk requires donors to provide surplus breast milk without using any milk formula.
If weaning has started, the donors’ babies need to exclusively eat weaning food and breast milk.

Delivery of donor milk to infants: from donors to The Nippon Foundation Human Milk Bank

Step.

Donor application (only available in Japan)

01

Candidates apply through the online registration form.

Step.

Medical interview and blood screening test

01

Applicants complete a medical interview and blood screening test.
02

If there are no problems with the results, the applicant will be registered as a donor.

Step.

Milking and freezing

01

Donors collect excess milk while maintaining a balance with breastfeeding.
02

Donors freeze the milk in a clean bag to prevent mixing with other foods.

Step.

Shipping breast milk

01

Before shipping, donors check for any foreign matter. (If any contaminant is found, it cannot be used.)
02

Using a specialized shipping service, donors send the frozen breast milk to The Nippon Foundation Human Milk Bank.
03

The organization covers the shipping cost.

Notes after donor registration
Even registered donors may not be able to donate breast milk temporarily in the following cases:
① They have an acute infectious disease, mastitis, or other teat or breast infection.
② A family member has had rubella (three-day measles) or chickenpox (until four weeks have passed after the infectious disease has disappeared).
③ They have herpes simplex or shingles on the breast or chest (until one week has passed since all scabs have formed).
④ Until 12 hours have passed after consuming alcohol.
⑤ Until 21 days have passed if donors or their family members have been vaccinated against smallpox.
⑥ Until eight days have passed after tattooing (with a clean needle and syringe in an approved place).
⑦ Until one month has passed after vaccination against mumps, measles, rubella, and chickenpox.
⑧ They or a close contact have become infected with the coronavirus.

About donor’s and recipient’s personal information
・The Nippon Foundation Human Milk Bank will retain donor milk-related information and the personal information of donors and recipients until the recipient reaches 21 years of age.
・Donor milk and donor information will be shared by The Nippon Foundation Human Milk Bank and the Japan Human Milk Bank Association.

About donor’s personal information

① Donor registration records (name, address, date of birth, telephone number, etc.)
② Health condition at the time of donor milk submission
③ Consent form for donor registration

About recipient’s personal information

① Number of weeks in utero, birth weight, age in days, weight at the time of feeding, the amount used, diagnosis name, unique ID, and batch number of donor milk given
② Consent form for using donor milk
③ Records summarizing the progress during hospitalization
④ Growth and development after discharge

Delivery of Donor Milk to BabiesDelivery of donor milk to infants: from The Nippon Foundation Human Milk Bank to infants

Step.

The Nippon Foundation Human Milk Bank receives and stores the donor milk

01
We confirm that the frozen donor milk has not melted.
02
We verify that it is not damaged.
03
While wiping each container with an alcohol swab, we visually inspect the contents for any foreign matter.
04
Frozen donor milk is stored in a freezer at minus 20°C or lower.

Step.

Low-temperature Pasteurization

The milking date is checked and the donation is pasteurized within three months of it. Generally, only one donor’s milk is handled in one pasteurization treatment. In the long-term, donor milk from multiple donors may be mixed to eliminate variations in nutrients. Frozen donor milk is defrosted in a refrigerator overnight. The next day, we make sure it is thawed and perform the following steps:

01
Empty the entire donor milk pack into a disinfected flask.
02
Cleanly collect a portion of it from the flask and test for bacteria.
03
After stirring, separate the donor milk into containers and seal.
04
Pasteurize the donor milk in the containers at 62.5°C for 30 minutes.
05
Divide it into small containers and freeze.
06
Only donor milk that is determined to be usable after bacterial testing is stored in a dedicated freezer.

Note:

If pathogenic bacteria are detected before pasteurization, the milk is not used.
The condition for using donor milk is that no bacteria are cultured in bacteriological tests after the pasteurization process.
The expiration date of pasteurized donor milk is within three months. If it is not used within this period, it is discarded.
Hospital infection control members regularly check the human milk bank to ensure a hygienic environment.
The Nippon Foundation Human Milk Bank meets the standards of the Human Milk Banking Association of North America.

Step.

Donor Milk Identification

01
Donor milk is labeled with a batch number that is generated when it is processed.
02
The records of infants who have received donor milk will include the batch number and the dose administered.
03
If there is a problem, the records are trackable.

Step.

Shipping pasteurized donor milk to NICUs

01
Frozen pasteurized milk is shipped from The Nippon Foundation Human Milk Bank to each facility upon request from NICUs.
02
The delivery usually takes one day, but depending on the region, it can take two.
03
NICUs receive and store the donor milk at -20C at each facility.
04
The infant’s doctor considers the need for donor milk, explains donor milk to the parent(s), and obtains written consent.
05
Donor milk is tube fed to the infant.

Step.

Handling donor milk in NICUs

01
The nurse in charge, together with the doctor, confirms that the infant who will be given the donor milk is the correct recipient and the parent(s) has given consent.
02
The doctor and nurse check the batch number and expiration date on the container, and the doctor notes the batch number in the infant's medical record.
03
When the donor milk is thawed and dispensed into the receptacle, the nursing staff double-check to make sure that it is the correct donor milk for that baby.
04
The amount of donor milk given from each batch number will be noted in the medical record.