To review the standard processing and testing of human donors and donor milk and to report the frequency of detected markers of potential harm.STUDY DESIGN:
This was a retrospective analysis of the data gathered by a donor and human milk screening and monitoring process over a period of 3 years.RESULTS:
Screening results from 2011 to the end of 2015 demonstrated that careful history taking resulted in rejection or hold of 29.7% of willing donor candidates. Individual infection screening tests rejected an additional 0.3–2.9 per 1000 donations. DNA fingerprinting of donations eliminated 2 out of 13 491. Drug testing rejected 42 out of 12 408 and dilution or adulteration eliminated 73 out of 4935 donations. Only the dilution rejection rate was significantly higher in the remunerated donors. The details of these results are presented.CONCLUSIONS:
There are significant risks involved in the collection, processing and distribution of donor milk-based products. The behaviors of the donors, biochemical and genetic screening and milk processing are critical to mitigation of these recognized risks. Testing at this level of rigor appears to be justified.