From Donor to Vulnerable Neonate: Implementing True Bi-Directional, Cross-Border Traceability for Pasteurized Donor Human Milk

The implementation of Regulation (EU) 2024/1938-the Substances of Human Origin (SoHO) Regulation-fundamentally reclassifies pasteurized donor human milk (DHM) as a regulated biological substance. This shifts its clinical management into a strict quality and safety framework identical to blood banking and tissue transplantation. With full enforcement mandated by August 2027, European healthcare facilities must replace manual, error-prone enteral workflows with automated, bi-directional digital traceability infrastructure. This review outlines a comprehensive framework for establishing absolute forward (donor-to-recipient) and reverse (recipient-to-donor) tracking pathways, drawing direct parallels to established vein-to-vein practices in transfusion medicine. Central to this cross-border standardization is the mandatory integration of the Single European Code (SEC) and global ISBT 128 coding standards to secure donation sequences, facilitate safe international distribution, and eliminate transcription vulnerabilities. The analysis details critical risk-mitigation strategies under the new SoHO mandates. These include automated system interlocks to enforce biological quarantine, closed-loop bedside validation to intercept Serious Adverse Occurrences (SAOs), and cloud-based ledger solutions capable of sustaining the strict 30-year data retention mandate. Furthermore, the review explores the collateral safety benefits of leveraging this digital infrastructure to harmonize the handling of non-regulated expressed human milk (EHM), thereby eliminating hazardous two-tier safety systems within the Neonatal Intensive Care Unit (NICU). Ultimately, this paper provides clinical leaders and hospital administrators with actionable guidance and an institutional procurement checklist to achieve immediate digital readiness, asserting that automated traceability is the definitive, legally mandated pathway to safeguarding vulnerable neonatal populations.