Advancing Safety, Quality, and Equitable Access to Pasteurized Donor Human Milk
By: Veronica Raciti, RDN, CBS and Amy Vickers, MSN, RN, IBCLC, ASQ-CQA, Timeless Medical Systems®
An exclusive human milk diet is widely recognized as the optimal source of nutrition for infants, particularly those born prematurely or with complex medical needs. When a birth parent’s own milk is unavailable or insufficient, pasteurized donor human milk (PDHM) has become an essential component of neonatal care.1 Once considered an extraordinary intervention, reserved for exceptional circumstances, PDHM has evolved over the past three decades into a cornerstone of evidence-based practice in neonatal intensive care units (NICUs). Today, its success depends not only on the remarkable biological properties of human milk but also on the sophisticated systems that ensure every ounce is safe, traceable, and available to the infants who need it most.1
A System Built on Safety
The foundation of every successful donor milk program begins long before milk reaches the hospital. Safety is maintained through rigorous standards established by the Human Milk Banking Association of North America (HMBANA), the nonprofit organization responsible for accrediting milk banks across North America.2 To achieve and maintain accreditation, milk banks undergo comprehensive annual audits and adhere to evidence-based protocols governing every stage of milk collection, processing, storage, and distribution.2
Potential donors complete an extensive screening process that includes detailed medical and lifestyle questionnaires, healthcare provider approval, and laboratory testing for infectious diseases such as HIV, HTLV, syphilis, and hepatitis B and C.2 Only after successfully meeting these requirements can milk be accepted into the banking system.
Once donated, milk is cataloged, frozen, and carefully pooled with milk from other qualified donors. Although pooling may seem like a simple logistical step, it serves an important nutritional purpose. Human milk naturally varies in fat, protein, and lactose content between mothers and even throughout the day. Combining milk from multiple donors helps reduce this variability, creating a more consistent nutritional profile for medically fragile infants.3
The pooled milk then undergoes Holder pasteurization, in which it is heated to 62.5°C for 30 minutes. This carefully validated process effectively destroys pathogenic bacteria and viruses while preserving many of the protective bioactive components that make human milk uniquely valuable.2 After pasteurization, and before it is approved for clinical use, every batch undergoes microbiological testing.2 Only milk that meets strict safety standards is released for distribution to hospitals.
While these safeguards are essential, producing safe donor milk is only part of the journey. Maintaining its integrity from the milk bank to the infant requires equally rigorous systems for tracking and accountability.
PDHM Tracking
Modern milk banks process thousands of ounces of milk each week, making precise documentation indispensable. Every container must be traceable from donor to recipient, with records documenting donor information, expression dates, storage conditions, pasteurization cycles, microbiological testing, and distribution history.2 To accomplish this, most accredited milk banks rely on barcode technology that allows every milliliter of milk to be tracked throughout its lifecycle. This level of traceability not only strengthens quality assurance but also enables rapid investigation should any safety concern arise.2
The same commitment to precision continues once donor milk arrives in the NICU. Hospitals increasingly integrate feeding preparation software with the milk bank’s barcode system, allowing donor milk to move seamlessly from receipt through preparation and bedside administration. Compatibility between these systems minimizes manual transcription, improves inventory management, and reduces opportunities for human error.4 This is why platforms like Timeless Medical Systems® Milk Bank Management System™ have become the industry benchmark, powering the milk bank management software that handles end-to-end tracking for 85% of HMBANA milk banks.
Barcode technology has become particularly valuable during bedside administration. Consistent with National Patient Safety Goals, clinicians verify at least two patient identifiers before feeding.5 Scanning both the infant’s identification and the donor milk barcode provides an additional layer of protection by confirming the correct milk reaches the correct patient while preserving complete batch traceability throughout the feeding process. These technologies have become powerful tools for reducing preventable feeding errors and strengthening patient safety.5
Equitable Access to PDHM
Despite remarkable advances in safety and quality, equitable access to PDHM remains an ongoing challenge. Access often varies according to hospital resources, geographic location, insurance coverage, and institutional policies. A national survey conducted by the Centers for Disease Control and Prevention found that 13% of advanced neonatal units lacked donor milk for very low birth weight infants, while 44% of hospitals with fewer than 1,000 annual births had no established procurement protocol.6 These disparities highlight that scientific progress alone is insufficient if life-saving nutrition cannot consistently reach every eligible infant.
Recognizing these challenges, HMBANA developed the Equitable Milk Access Blueprint, bringing together national experts to identify barriers and provide practical recommendations for healthcare organizations.7 The Blueprint encourages hospitals to eliminate race-based decision models, strengthen breastfeeding support, educate clinicians and families, collaborate with accredited milk banks, advocate for insurance coverage, and ensure equitable access to PDHM whenever medically appropriate.7
Although parental acceptance of donor milk is generally high, hesitation often stems from limited understanding of donor screening, pasteurization, or milk bank safety practices rather than opposition to donor milk itself.8 Structured informed consent provides families with an opportunity to understand how donor milk is collected, processed, and protected while allowing clinicians to answer questions and support informed decision-making. Evidence suggests that comprehensive education significantly improves acceptance.8
National momentum continues to strengthen donor milk infrastructure. Legislative efforts such as the Access to Donor Milk Act of 2023 seek to expand nonprofit milk banking capacity, improve emergency preparedness, and support broader access.9 At the same time, HMBANA milk banks distributed more than 11.6 million ounces of donor milk in 2024, representing a 9% increase over the previous year, with nearly one-quarter supporting outpatient use.9 Further recognition came with the Joint Commission’s 2026 Exclusive Human Milk Feeding quality measure, which includes PDHM as part of exclusive human milk feeding metrics, reinforcing its role as an evidence-based standard of neonatal nutrition.5
The evolution of pasteurized donor human milk reflects more than advances in nutrition science. It demonstrates what is possible when evidence-based medicine, technology, quality improvement, and compassionate care work together toward a common purpose. Success will require continued investment in standardized workflows, interoperable barcode technology, comprehensive family education, equitable access initiatives, and ongoing collaboration among clinicians, milk banks, policymakers, and healthcare systems.
Closing the Gap with Timeless Medical Systems®
Achieving total traceability and equitable access requires robust infrastructure. At Timeless Medical Systems, we specialize in turning these clinical standards into seamless bedside realities. As the trusted partner protecting the workflows of over 85% of HMBANA-accredited milk banks, our Timeless Milk Bank Management System™ and Timeless Medical Nutrition Platform™ provide an unbroken digital chain of custody. From donor screening and pasteurization tracking at the milk bank to safe barcode verification at the NICU bedside, we ensure that every milliliter of pasteurized donor human milk is validated, safe, and precisely tracked.
PDHM Hospital Readiness Consideration Questions
- Does your hospital partner with a HMBANA accredited human milk bank that utilizes advanced barcode scanning?
- Does your NICU utilize software that supports complete, electronic traceability of PDHM from donor milk bank receipt to bedside administration?
- Has your hospital integrated standardized PDHM education, informed consent, and clinical decision-making into our NICU workflow?
- Does your hospital have software-driven “hard stops” at the point of care to eliminate feeding errors and ensure the right milk reaches the right infant?
- Does your hospital monitor equitable access to PDHM and breastfeeding support across all NICU populations?
Is your unit fully equipped for the future of neonatal nutritional safety? Learn how Timeless Medical Systems can elevate your facility’s safety standards, streamline audit readiness, and protect your most vulnerable patients. Visit www.timelessmedical.com or connect with our clinical technology team at sales@timelessmedical.com to schedule a demonstration.
About the authors
Veronica Raciti RDN, CBS is a Clinical Specialist at Timeless Medical Systems, using her specialized clinical background to support clients implementing the Timeless Medical Nutrition Platform™. Veronica was recently the Manager of Formula and Human Breast Milk at Children’s Hospital of Philadelphia. She is passionate about patient safety and the importance of nutrition to vulnerable patients.
Amy Vickers MSN, RN, IBCLC, ASQ-CQA is a Milk Banking Consultant at Timeless Medical Systems. She served as the founding Executive Director of the Mothers’ Milk Bank of North Texas and also held leadership positions in HMBANA including President and Treasurer. She helps Timeless Medical Systems to develop cutting edge milk bank solutions, providing guidance on clinical best practice.
Resources
- American Academy of Pediatrics. Breastfeeding and the use of human milk. Pediatrics. 2022;150(1):e2022057988. doi:10.1542/peds.2022-057988
- Human Milk Banking Association of North America. The Equitable Milk Access Blueprint. 2024.
- Maternal & Child Nutrition, (2025. November) Evaluating the Effect of Random Multi‐Donor Pooling on the Nutritional Variability in Donor Human Milk Using Computer Modeling 22:e70158
- American Society for Parenteral and Enteral Nutrition (ASPEN). (2025) Practice Tool:Preventing Errors with Barcode Scanning for Enteral Nutrition.
- Joint Commission (2025. August) Specifications Manual for Joint Commission National Quality Measures (v2026A) Exclusive Human Milk Feeding
- Centers for Disease Control and Prevention. (2022). Human Milk Banking Practices in the United States — 2020. MMWR. Morbidity and Mortality Weekly Report, 71(33), 1059–1063.
- Human Milk Banking Association of North America. The Equitable Milk Access Blueprint. 2024.
- Brownell, E. A., Lussier, M. M., Herson, V. C., Hagadorn, J. I., & Marinelli, K. A. (2014). Patterns and predictors of donor human milk non-consent in the neonatal intensive care unit. Breastfeeding Medicine, 9(10), 533–539.
- Human Milk Banking Association of North America. (2025, September 22). HMBANA updated statement on milk supply for small vulnerable newborns.
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The material presented in this blog represents the opinion of the author(s) and not necessarily the views of Synova Associates. Synova Associates does not endorse any specific products or organizations but strives to connect its industry partners with leaders interested in product/educational innovation.
