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Safety of donor milk: a brief report
1Department of Neonatology Wesley Medical Center, Wichita, KS, USA.
Objective:
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.
Insights
Rigorous screening of human milk donors, including history, infection tests, DNA fingerprinting, and drug testing, is crucial for safety. This process effectively identifies and rejects candidates and donations with potential risks, ensuring safer donor milk products.
Area of Science:
- Biomedical Science
- Public Health
- Neonatal Care
Background:
- Donor human milk is vital for vulnerable infants when maternal milk is unavailable.
- Ensuring the safety of donor milk involves comprehensive screening of donors and milk products.
- Previous studies highlight the importance of donor screening but lack detailed frequency data on rejection markers.
Purpose of the Study:
- To review standard processing and testing protocols for human milk donors and donor milk.
- To quantify the frequency of detected markers of potential harm in donor milk.
- To evaluate the effectiveness of current screening measures in mitigating risks associated with donor milk.
Main Methods:
- Retrospective analysis of donor screening and monitoring data from 2011 to 2015.
- Review of data encompassing donor history, infection screening, DNA fingerprinting, and drug testing.
- Analysis of milk samples for dilution or adulteration.
Main Results:
- Careful donor history taking led to the rejection or hold of 29.7% of candidates.
- Individual infection screening rejected 0.3-2.9 per 1000 donations.
- DNA fingerprinting eliminated 2/13,491 donations; drug testing rejected 42/12,408; dilution/adulteration eliminated 73/4935 donations. Dilution rates were higher in remunerated donors.
Conclusions:
- Significant risks are associated with the collection, processing, and distribution of donor milk.
- Donor behavior, biochemical/genetic screening, and milk processing are critical for risk mitigation.
- The implemented level of testing rigor is justified to ensure donor milk safety.
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