by Jean M. Drulis, B.A., Director and Co-founder of Mother’s Milk Bank of Iowa
Healthy, lactating women with surplus human milk have choices for it. They produce plenty of milk to feed their own infant(s) and have extra. They can donate it to a non-profit milk bank like the Mother’s Milk Bank of Iowa, donate or sell it peer-to-peer, donate or sell it to a for profit company, do a combination of these or discard it. The focus here is on charitable human milk donations to non-profit milk banks in North America where the operational milk banks follow essential screening and safety standards established by the Human Milk Banking Association of North America (HMBANA).
The Mother’s Milk Bank of Iowa and the other 29 member milk banks adhere to HMBANA’s mandatory standards, “HMBANA Standards for Human Milk Banking.”1 It contains evidence-based instructions for screening milk donors and serologic testing, pasteurizing donor milk using the Holder method and microbial testing thereafter, appropriate handling, freezing, defrosting, pooling, labeling and dispensing milk by prescription or hospital order and shipping it.
Remarkable Milk Donors
According to Best Practice for Expressing, Storing, and Handling Human Milk, less than 1% of possible donors apply to donate to non-profit milk banks.2 Milk donors are truly remarkable. They are humanitarians with enormous public spirit. They donate their excess milk to a HMBANA-member milk bank after they have been screened and approved by the milk bank. They do not receive payment for their free-will gifts of milk. Their precious milk is pooled with the milk of 2-4+ other approved donors, pasteurized, tested post-pasteurization and dispensed to infants in hospitals and at home. Pooling the milk from multiple donors yields a relatively consistent protein and fat content.3 Human milk is baby’s 1st medication, is natural, health-giving and life-saving, especially for the fragile premature infant. The majority of women who become milk donors have surplus milk; however, there are also bereaved, surrogate and gestational carrier donors. In addition, women who restrict dairy in their diet may donate the milk they have while consuming dairy and now cannot feed to their own due to suspected cow milk allergy. They can also donate going forward their dairy-restricted milk. The frequency of cow milk allergy in the developed world is thought to be 2-3%; however, it is lower (0.5%) in breast-fed infants compared to formula-fed.4 The Mother’s Milk Bank of Iowa was launched on August 1, 2002, World Breastfeeding Day. Through 2018, 2,327 milk donors have been approved and donated. The majority of donors are from the heartland. Of the 99 counties in Iowa, we have had milk donors from 88 through 2018. We aim to have donors from every county. We ask that milk donors provide at least 200 ounces of milk during their entire donation experience. The average donation since inception is 666 ounces! The range is 4-20,729 ounces. In 2019, 89% of the pasteurized milk we dispensed was to 56 hospitals in 12 states. The remaining 11% went to infants at home.
Milk Donor Screening
Lactating women who are non-smokers, not on medication (with a few exceptions) and have an abundance of milk contact our milk donor coordinator about becoming a milk donor. There are 5 steps in the screening process.
Step One: Pre-Screening
Read the pre-screening information for milk donors.5 This facilitates the screening, will save time and effort and identify if there are any general disqualifications.
Step Two: Verbal Screening
If there are no exclusions identified from the pre-screening document, the next step is scheduling/completing the verbal screening. This screening must be done over the phone or in-person. It involves a series of questions about the donor’s health and lifestyle. For example, she is asked about use of medications including herbal supplements. Some medications are not exclusions (multivitamin, iron, human insulin, thyroid replacement hormones, Zoloft, Ibuprofen, Tylenol, nasal sprays, asthma inhalers, topical treatments, eye drops, progestin-only and low dose estrogen birth control products and a few more). Herbal supplements (fenugreek, etc.) are exclusions, including vitamin/herb combinations. The FDA regulates dietary supplements differently in that the company is responsible for evaluating the safety and labeling of it by following FDA standards and the Dietary Supplement Health and Education Act. The manufacturer and distributors apparently can take the new product to market, pre-marketing approval by the FDA is not required. The FDA takes action (post-market surveillance) after marketing if the product is reported to have issues.6,7
Step Three: Written Screening
A written questionnaire is sent after the verbal screening is completed successfully and there are no permanent exclusions identified. It asks about the health of the donor and her infant(s), her lifestyle, travel, milk collection/storage and general information. Examples of permanent exclusions are if she has a history of leukemia or lymphoma or if she is taking certain medications, i.e., antihypertensive, seizure, etc. A positive response to such questions would end the screening, she would be ineligible to donate. There are also temporary exclusions where she is ineligible to donate during a defined period. For instance, if she has live virus vaccines like the MMR, there is a 4 week deferral, varicella/chicken pox is 8 weeks.
Step Four: Serological Screening
Donors are screened serologically for Hepatitis B and C, HIV, HTLV and syphilis by a certified laboratory.
Step Five: Health Care Provider Statement
The health care provider for the mother and infant are informed and are sent forms to complete/sign. If either has a concern, the bank is notified. Milk donors are given educational materials concerning clean techniques for milk collection and storage, occasions when she should contact the milk bank and not donate, labeling her milk and transporting it to the milk bank or milk collection depot. After approval, donors are asked to contact the bank whenever sick, takes medication, has a change in lifestyle, has a vaccine, is exposed to an infectious disease and so on. Documented communication is recurrent. Donors sign a statement that being a milk donor for the Mother’s Milk Bank of Iowa is not an indication that her milk is safe to share peer-to-peer. Milk banks take several steps to assure the safety of donor milk beyond health and life-style screening of the donor including pasteurization and microbial testing post-pasteurization.
Milk Collection Depots
A milk collection depot is an agency affiliated with a milk bank that collects and stores donor milk from approved milk donors. They enhance donor milk delivery and are instrumental for increasing donor participation and donations. They promote, support and protect breastfeeding and the use of donor human milk. Depots distribute recruitment materials to area women at a prenatal visit, after delivery, at a postnatal visit and during breastfeeding classes, etc. or any combination thereof. They increase awareness about milk donations. They volunteer their time and efforts, are a vital and important community resource for families. The Mother’s Milk Bank of Iowa has 38 depots and counting that are located in Iowa, Minnesota, Nebraska, South Dakota and Wisconsin. We transport milk from all but 6 of these depots that are too far for a day transport, so they ship the milk. The majority are within hospitals. We provide a chest freezer that they maintain in a secure location.
Milk Donations During Covid-19
We attribute, in part, our recent upsurge in milk donations/donors to Covid-19. We never have received such an outpouring of milk, so much so that we purchased 6 additional double door upright freezers in the last 6 months. Some of our depots with full freezers are serving as holding sites temporarily. This is a vital role of depots, one we infrequently utilize, and when we do, it is mainly because of driver availability and scheduling. Our service has gone contactless, depot volunteers bring the milk outside to the driver. For milk deliveries, donors call when they arrive, put their precious donations in coolers in our lobby and return to their vehicle. Thereafter, the milk is taken to a freezer. When dispensing outpatient milk, the routine is similar, the recipient family calls, leaves the documents/prescription in a folder in our lobby, we fill the prescription and put the milk in a cooler in our lobby. The milk is then retrieved by the family. The procedure for shipping milk was already contactless, the driver picks it up in our lobby. This increase in donated milk has taken the Mother’s Milk Bank of Iowa to the next level, we are poised to serve more hospitals and home recipients thanks to the generosity of milk donors.
1 Human Milk Banking Association of North America. HMBANA Standards for Human Milk Banking (internet). 2020. 2 Jones, F. Best Practice for Expressing, Storing, and Handline Human Milk. 4th ed. HMBANA, 2019. 3 Drulis, J.M. et al.: Fat and Protein Content of Pooled Donor Human Milk is Relatively Constant. Mother’s Milk Bank of Iowa. Poster. International Society for Research in Human Milk and Lactation (ISRHL) Conference. Perth, Australia, February, 2008. 4 Edwards C.W. and Younus M.A. Cow Milk Allergy. [Updated 2020 Jun 29]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2020. Available from: https://www.ncbi.nlm.nih.gov/books/NBK542243. 5 https://uichildrens.org/health-library/milk-donor-pre-screening-information, 2020. 6 Thakkar, S. et al., Regulatory Landscape of Dietary Supplements and Herbal Medicines from a Global Perspective. Regul. Toxicol. Pharmacol. 114:104647, 2020. 7 https://www.fda.gov/food/dietary-supplements, 2019.