Donor and recipient safety in human milk banking

Area of Science:

• Neonatal nutrition and safety
• Biovigilance in human milk banking
• Public health and transfusion medicine

Background:

• Australian Red Cross Lifeblood provides pasteurised donor human milk (PDHM) to over 30 hospitals for vulnerable preterm infants.
• Formal biovigilance programs are uncommon in human milk banking, despite the vulnerable recipient population.
• Lifeblood Milk conducts continuous surveillance of donor and recipient adverse events.

Purpose of the Study:

• To formally review adverse events reported to Lifeblood Milk between July 2018 and December 2021.
• To assess the safety profile of pasteurised donor human milk (PDHM) in a clinical setting.

Main Methods:

• Prospective recording of milk donor infectious disease testing outcomes and donor adverse events (DAEs).
• Contractual reporting of infant recipient adverse events by hospitals, with assessment of severity and causality.
• Review of donor and recipient adverse events over a 3.5-year period.

Main Results:

• Three DAEs (0.31%) occurred, related to phlebotomy (vasovagal reactions, haematoma).
• Eight donors (0.81%) had biological false reactive infectious disease serology results.
• Ten suspected recipient adverse events were reported; none were causally related to PDHM, including infection, obstruction, and high iodine levels.

Conclusions:

• Donor adverse events were infrequent, though biological false reactive serology results were noted.
• No recipient adverse events were considered causally linked to pasteurised donor human milk administration.
• Pasteurised donor human milk is a low-risk biological product, but ongoing biovigilance is essential for safety.