{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,23]],"date-time":"2026-01-23T07:12:36Z","timestamp":1769152356201,"version":"3.49.0"},"reference-count":23,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2022,7,2]],"date-time":"2022-07-02T00:00:00Z","timestamp":1656720000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["J Paediatrics Child Health"],"published-print":{"date-parts":[[2022,9]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>Australian Red Cross Lifeblood supplies pasteurised donor human milk (PDHM) to more than 30 partner hospitals across Australia. Preterm infants who receive PDHM are a highly vulnerable population but formal biovigilance programs are rare in human milk banking. Lifeblood Milk performs ongoing surveillance for both donor and recipient adverse events. This study aimed to formally review adverse events reported to Lifeblood Milk since 2018.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Milk donor infectious diseases testing outcomes and donor adverse events (DAEs) are prospectively recorded at Lifeblood. Infant recipient adverse events are contractually reported back to Lifeblood Milk by hospitals and assessed according to severity and likelihood of relationship to PDHM administration. Donor and recipient adverse events over a 3.5\u2010year period (July 2018 to December 2021) were reviewed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>There were three DAEs (3\/976\u00a0=\u00a00.31%) related to phlebotomy; these included two vasovagal reactions and one phlebotomy site haematoma. Eight (8\/976\u00a0=\u00a00.81%) additional donors had biological false reactive (BFR) infectious diseases serology results. There were 10 reported suspected adverse events in recipients. Six were infection\u2010related; other events included milk curd obstruction, high urinary iodine levels, sudden cardiac death and nasogastric tube obstruction. All reported suspected adverse events in recipients were classified as unlikely to be related, or definitely not related, to PDHM administration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Milk donor adverse events were rare but biological false reactive\u00a0serology results were not uncommon. There were no recipient adverse events considered causally related to pasteurised donor human milk, which is generally a low\u2010risk biological product. Ongoing biovigilance remains essential.<\/jats:p><\/jats:sec>","DOI":"10.1111\/jpc.16066","type":"journal-article","created":{"date-parts":[[2022,7,2]],"date-time":"2022-07-02T13:05:10Z","timestamp":1656767110000},"page":"1629-1634","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Donor and recipient safety in human milk banking"],"prefix":"10.1111","volume":"58","author":[{"given":"Vanessa","family":"Clifford","sequence":"first","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"},{"name":"Department of Laboratory Services Royal Children's Hospital  Melbourne Victoria Australia"},{"name":"Department of Infection and Immunity Murdoch Childrens Research Institute  Melbourne Victoria Australia"},{"name":"Department of Paediatrics University of Melbourne  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7287-8029","authenticated-orcid":false,"given":"Laura D","family":"Klein","sequence":"additional","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"},{"name":"Departent of Institute of Pharmaceutical Sciences Monash University  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Richard","family":"Brown","sequence":"additional","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Sulfaro","sequence":"additional","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veronica","family":"Hoad","sequence":"additional","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iain B","family":"Gosbell","sequence":"additional","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"},{"name":"School of Medicine Western Sydney University  Penrith New South Wales Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joanne","family":"Pink","sequence":"additional","affiliation":[{"name":"Clinical Services and Research and Business Growth &amp; Innovation Australian Red Cross Lifeblood  Melbourne Victoria Australia"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,7,2]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/mcn.13131"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/jpc.14909"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13006-014-0023-4"},{"key":"e_1_2_7_5_1","unstructured":"International Society for Blood Transfusion.Standard for Surveillance of Complications Related to Blood Donation 2014."},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/vox.12675"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.3389\/fped.2019.00053"},{"key":"e_1_2_7_8_1","unstructured":"National Institute for Health and Clinical Excellence.Donor Breast Milk Banks: The Operation of Donor Milk Bank Services: NICE Clinical Guideline 93; 2010. Available from:www.nice.org.uk\/guidance\/CG93[accessed 28 September 2017]."},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clp.2016.11.006"},{"key":"e_1_2_7_10_1","unstructured":"National Blood Authority.Australian Haemovigilance Report 2018\u201319. 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