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What are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants?
J Hum Lact. 2021 Feb; 37(1):43-51.JH

Abstract

BACKGROUND

Definitive criteria for microbial screening of pasteurized donor human milk are not well established and international recommendations vary.

AIMS

(1) To review pasteurized donor human milk batch discard due to failed microbial screening criteria at our milk bank (following United Kingdom National Institute of Clinical Excellence guidelines), and (2) to compare our known milk discard proportion with estimated milk discard proportions that would be required by other international milk bank guidelines.

METHODS

We reviewed our microbial screening results (N = 783) over 18-months (July 2018-December 2019) and compared our known milk discard proportion with estimated milk discard proportions using other international milk bank guidelines.

RESULTS

Of samples, n = 50 (6.4%) failed pre-pasteurization screening, most commonly due to the presence of >104 CFU/mL Enterobacterales in the pre-pasteurization sample (n = 30; 3.8%). Two (0.3%) samples failed post-pasteurization screening, with Bacillus cereus identified in both cases, resulting in total discard proportion of 6.7% (n = 52) of batches. Applying European Milk Bank Association recommended bacterial screening criteria, approximately 23.3% (n = 183) of milk batches would have been discarded.

CONCLUSIONS

Further research is required to justify the stringent European Milk Bank Association recommendations for pre-pasteurization discard criteria, although we believe that a post-pasteurization acceptance criterion of <1 CFU/mL is appropriate and aligns with international guidance. Further work is needed to understand pasteurized donor human milk microbiological safety risks, to better integrate screening criteria within current food standards regulation, and to consider risk-based assessment including the impact on availability and affordability.

Authors+Show Affiliations

216919 Australian Red Cross Lifeblood, Australia. Murdoch Children's Research Institute, Flemington Rd, Parkville, VIC, Australia. School of Medicine, Dentistry and Health Sciences, University of Melbourne, Parkville, VIC, Australia.216919 Australian Red Cross Lifeblood, Australia.216919 Australian Red Cross Lifeblood, Australia.Dairy Technical Services Food Assurance, Silverwater, NSW, Australia.216919 Australian Red Cross Lifeblood, Australia.216919 Australian Red Cross Lifeblood, Australia. School of Medicine, Western Sydney University, Penrith, NSW, Australia.216919 Australian Red Cross Lifeblood, Australia.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

33351688

Citation

Clifford, Vanessa, et al. "What Are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants?" Journal of Human Lactation : Official Journal of International Lactation Consultant Association, vol. 37, no. 1, 2021, pp. 43-51.
Clifford V, Klein LD, Sulfaro C, et al. What are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants? J Hum Lact. 2021;37(1):43-51.
Clifford, V., Klein, L. D., Sulfaro, C., Karalis, T., Hoad, V., Gosbell, I., & Pink, J. (2021). What are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants? Journal of Human Lactation : Official Journal of International Lactation Consultant Association, 37(1), 43-51. https://doi.org/10.1177/0890334420981013
Clifford V, et al. What Are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants. J Hum Lact. 2021;37(1):43-51. PubMed PMID: 33351688.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - What are Optimal Bacteriological Screening Test Cut-Offs for Pasteurized Donor Human Milk Intended for Feeding Preterm Infants? AU - Clifford,Vanessa, AU - Klein,Laura D, AU - Sulfaro,Christine, AU - Karalis,Tass, AU - Hoad,Veronica, AU - Gosbell,Iain, AU - Pink,Joanne, Y1 - 2020/12/22/ PY - 2020/12/23/pubmed PY - 2021/11/26/medline PY - 2020/12/22/entrez KW - breastfeeding KW - human milk KW - human milk production KW - milk bank SP - 43 EP - 51 JF - Journal of human lactation : official journal of International Lactation Consultant Association JO - J Hum Lact VL - 37 IS - 1 N2 - BACKGROUND: Definitive criteria for microbial screening of pasteurized donor human milk are not well established and international recommendations vary. AIMS: (1) To review pasteurized donor human milk batch discard due to failed microbial screening criteria at our milk bank (following United Kingdom National Institute of Clinical Excellence guidelines), and (2) to compare our known milk discard proportion with estimated milk discard proportions that would be required by other international milk bank guidelines. METHODS: We reviewed our microbial screening results (N = 783) over 18-months (July 2018-December 2019) and compared our known milk discard proportion with estimated milk discard proportions using other international milk bank guidelines. RESULTS: Of samples, n = 50 (6.4%) failed pre-pasteurization screening, most commonly due to the presence of >104 CFU/mL Enterobacterales in the pre-pasteurization sample (n = 30; 3.8%). Two (0.3%) samples failed post-pasteurization screening, with Bacillus cereus identified in both cases, resulting in total discard proportion of 6.7% (n = 52) of batches. Applying European Milk Bank Association recommended bacterial screening criteria, approximately 23.3% (n = 183) of milk batches would have been discarded. CONCLUSIONS: Further research is required to justify the stringent European Milk Bank Association recommendations for pre-pasteurization discard criteria, although we believe that a post-pasteurization acceptance criterion of <1 CFU/mL is appropriate and aligns with international guidance. Further work is needed to understand pasteurized donor human milk microbiological safety risks, to better integrate screening criteria within current food standards regulation, and to consider risk-based assessment including the impact on availability and affordability. SN - 1552-5732 UR - https://www.unboundmedicine.com/medline/citation/33351688/What_are_Optimal_Bacteriological_Screening_Test_Cut_Offs_for_Pasteurized_Donor_Human_Milk_Intended_for_Feeding_Preterm_Infants DB - PRIME DP - Unbound Medicine ER -