The knowns and unknowns of human milk banking.

The PREM Bank has been providing pasteurised donor human milk (PDHM) to very preterm for the past 3 years. It is the first human milk bank (HMB) to operate in Australia in over 20 years. Our community has rapidly embraced the concept of human milk banking, with both donations and demand for PDHM exceeding expectations. Providing PDHM in 'exceptional circumstances' where a mothers' own milk is unavailable is supported by the WHO and UNICEF. We submit that neonatal intensive care is an exceptional circumstance. Although evidence supporting PDHM use from randomised control trial (RCT) is limited, the latest systematic reviews suggest a lower risk of necrotising enterocolitis with PDHM as opposed to artificial formula. Study design and ethical issues may limit future evidence from RCT. We therefore support the ongoing use of PDHM in neonatal care, where provided by an appropriately managed HMB. Internationally many HMBs operate unregulated, and this is also the case in Australia. To ensure safety the PREM Bank has committed to meet the appropriate standards recommended in the Code of Good Manufacturing Practices (Blood and Tissues) in Australia and models risk management during processing on Codex HACCP (Hazard Analysis Critical Control Point) requirements. There is scope to continually re-evaluate the screening of donors and quality standards recommended during HMB. This will be most effective if strong networks of HMBs are developed with regional reference laboratories to encourage compliance with safety guidelines. HMB networks will facilitate collection of evidence for refining HMB practice and improving outcomes for preterm and sick infants.