Benefit by design: Determining the 'value' of donor human milk and medical products derived from human milk in NICU

The use of donor human milk to provide therapeutic benefit to infants should only proceed where there is positive 'value'. This can be determined through an assessment of the benefit and the known risks. The emergence of new products derived from human milk requires new value assessments. The known hazards in human milk are modified by differences in the donor selection, processing methods and intended use and result in a unique risk assessment where any of these factors vary. The human source of the raw product requires high ethical standards in the design of these services with care taken to protect donors and recipients from harm. Any supplement to maternal milk should be provided cautiously to avoid displacement of maternal lactation. (C) 2019 Elsevier Inc. All rights reserved.