A comparative review of human milk banking and national tissue banking programs.

donor human milk medical products of human origin milk bank mother's own milk

Journal

Maternal & child nutrition
ISSN: 1740-8709
Titre abrégé: Matern Child Nutr
Pays: England
ID NLM: 101201025

Informations de publication

Date de publication:
29 Apr 2024
Historique:
revised: 18 10 2023
received: 13 01 2023
accepted: 24 10 2023
medline: 30 4 2024
pubmed: 30 4 2024
entrez: 30 4 2024
Statut: aheadofprint

Résumé

This paper explores the legislative and operational commonalities and differences in Medical Products of Human Origin (MPHO) programs, including blood, hematopoietic cells, tissues and reproductive cells and human milk banking. The analysis includes ethical principles in donation and utilization, policies and legislation, public awareness and education, registries, guidelines in donor selection, safety and quality assurance, operational models and funding, infrastructure and human resources and biovigilance and evaluation of outcomes. Unlike other MPHO, the need for donor human milk (DHM) may be greatly reduced, that is, by ensuring optimal support for maternal lactation and breastfeeding. This should not be lost in the drive for wider and improved service provision. Nevertheless, increased overall demand for DHM is expected as a result of forthcoming international recommendations and also its increased use as the first-choice supplement to a mother's own milk both within and beyond preterm, low-birthweight and sick infant populations. Insight into current human milk banking highlights differences and gaps in practices that can benefit from further exploration and harmonization. Strong similarities with the ethical and operational principles underpinning donation and processing of the diverse MPHO suggest that legislating human milk banks within similar MPHO frameworks may bring additional safety and facilitate improved product quality. Moreover, that MPHO-inspired models operating within attainable regulatory requirements may contribute to sustainable human milk banking activity and growth.

Identifiants

pubmed: 38685628
doi: 10.1111/mcn.13584
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e13584

Subventions

Organisme : Family Larsson-Rosenquist Foundation

Informations de copyright

© 2023 The Authors. Maternal & Child Nutrition published by John Wiley & Sons Ltd.

Références

Ashford, P., Chapman, J., Hildebrandt, M., Noël, L., Pruett, T., Slaper‐Cortenbach, I., & Wilson, D. (2021). Establishing consensus on ethics, traceability and biovigilance for medical products of human origin. Bulletin of the World Health Organization, 99(12), 907–909. https://doi.org/10.2471/BLT.21.285484
Ashford, P., & Delgado, M. (2017). ISBT 128 standard for coding medical products of human origin. Transfusion Medicine and Hemotherapy, 44(6), 386–390.
Clifford, V., Klein, L. D., Brown, R., Sulfaro, C., Hoad, V., Gosbell, I. B., & Pink, J. (2022). Donor and recipient safety in human milk banking. Journal of Paediatrics and Child Health, 58(9), 1629–1634. https://doi.org/10.1111/jpc.16066
European Union. (2022). Proposal for a regulation on substances of human origin. Retrieved November 24, 2022, from: https://health.ec.europa.eu/blood-tissues-cells-and-organs/overview/proposal-regulation-substances-human-origin_en
Gkioka, V., Tsirigotis, P., Sarris, M., Soulis, S., Apostolou, A., Noutsias, M., Dimitriadis, G., Kostakis, A., Boletis, I., & Karabinis, A. (2018). Biovigilance for the quality and safety of medical products of human origin. Journal of Clinical Medicine Research, 10(12), 857–867. https://doi.org/10.14740/jocmr3549w
Israel‐Ballard, K., Cohen, J., Mansen, K., Parker, M., Engmann, C., Kelley, M., Brooks, E., Chatzixiros, E., Clark, D., Grummer‐Strawn, L., Hartmann, B., Kennedy, S., Kent, G., Mwangome, M., Nyirenda, D., Perrin, M. T., Picaud, J. C., Reimers, P., Roest, J., … Zambrano, P. A. (2019). Call to action for equitable access to human milk for vulnerable infants. The Lancet Global Health, 7(11), e1484–e1486. https://doi.org/10.1016/S2214-109X(19)30402-4
Kantorowska, A., Wei, J. C., Cohen, R. S., Lawrence, R. A., Gould, J. B., & Lee, H. C. (2016). Impact of donor milk availability on breast milk use and necrotizing enterocolitis rates. Pediatrics, 137(3), e20153123. https://doi.org/10.1542/peds.2015-3123
Karadag, A., Ozdemir, R., Ak, M., Ozer, A., Dogan, D. G., & Elkiran, O. (2015). Human milk banking and milk kinship: Perspectives of mothers in a Muslim country. Journal of Tropical Pediatrics, 61(3), 188–196. https://doi.org/10.1093/tropej/fmv018
Khalil, A., Buffin, R., Sanlaville, D., & Picaud, J. C. (2016). Milk kinship is not an obstacle to using donor human milk to feed preterm infants in Muslim countries. Acta Paediatrica, 105(5), 462–467. https://doi.org/10.1111/apa.13308
Klotz, D., Wesołowska, A., Bertino, E., Moro, G. E., Picaud, J. C., Gayà, A., & Weaver, G. (2021). The legislative framework of donor human milk and human milk banking in Europe. Maternal & Child Nutrition, 18, e13310. https://doi.org/10.1111/mcn.13310
Kontopodi, E., Arslanoglu, S., Bernatowicz‐Lojko, U., Bertino, E., Bettinelli, M. E., Buffin, R., Cassidy, T., van Elburg, R. M., Gebauer, C., Grovslien, A., Hettinga, K., Ioannou, I., Klotz, D., Mileusnić‐Milenović, R., Moro, G. E., Picaud, J. C., Stahl, B., Weaver, G., van Goudoever, J. B., & Wesolowska, A. (2021). “Donor milk banking: Improving the future”. A survey on the operation of the European donor human milk banks. PLoS One, 16(8), e0256435. https://doi.org/10.1371/journal.pone.0256435
Martin, D. E. (2017). Ethical aspects of medical products of human origin. ISBT Science Series, 12(1), 281–287.
Mondkar, J., Chawla, D., Sachdeva, R. C., Manerkar, S., Shanbhag, S., Khan, A., Manuhar, M., Wankhede, M. G., Thakur, V., & Israel‐Ballard, K. (2022). Impact of mother‐baby friendly initiative plus approach on improving human milk feeding for neonates in hospital: A quality improvement before‐and‐after uncontrolled study. European Journal of Pediatrics, 181(1), 107–116. https://doi.org/10.1007/s00431-021-04141-9
Newman, S., & Nahman, M. (2020). Nurture commodified? An investigation into commercial human milk supply chains. Review of International Political Economy, 29, 1967–1986. https://doi.org/10.1080/09692290.2020.1864757
NICE. (2010). Donor milk banks: The operation of donor milk bank services. Retrieved May 26, 2022 from: http://www.nice.org.uk/guidance/cg93
Noël, L., & Martin, D. (2015). The exception of medical products of human origin: Towards global governance tools. In R. Jean‐Daniel, B. Samira El (Eds.), New cannibal markets: Globalization and commodification of the human body (p. 383). Edition Foundations Maison des Sciences de l'Homme.
Quigley, M., Embleton, N. D., & McGuire, W. (2019). Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database of Systematic Reviews, 7, CD002971. https://doi.org/10.1002/14651858.CD002971.pub5
Quigley, M. A., Henderson, G., Anthony, M. Y., & McGuire, W. (2007). Formula milk versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database of Systematic Reviews, 7(7), Cd002971. https://doi.org/10.1002/14651858.CD002971.pub2
Quigley, M., & McGuire, W. (2014). Formula versus donor breast milk for feeding preterm or low birth weight infants. Cochrane Database of Systematic Reviews, 7(7), CD002971. https://doi.org/10.1002/14651858.CD002971.pub3
Reimers, P., & Coutsoudis, A. (2021). Donor human milk banking‐time to redirect the focus? Journal of Human Lactation, 37(1), 71–75. https://doi.org/10.1177/0890334420941805
Shenker, N., Aprigio, J., Arslanoglu, S., Aye, N. S. S., Bærug, A., Bar Yam, N., Barnett, D., Bellad, R., Bertino, E., Bethou, A., Bharadva, K., Olin, A. B., Billeaud, C., Buffin, R., Cassidy, T., Chugh Sachdeva, R., Clifford, V., Coutsoudis, A., Deb, S., … Wright, J. (2020). Maintaining safety and service provision in human milk banking: A call to action in response to the COVID‐19 pandemic. The Lancet Child & Adolescent Health, 4(7), 484–485. https://doi.org/10.1016/S2352-4642(20)30134-6
Stevens, J., & Keim, S. A. (2015). How research on charitable giving can inform strategies to promote human milk donations to milk banks. Journal of Human Lactation, 31(3), 344–347. https://doi.org/10.1177/0890334415571458
Titmuss, R. (1997). The gift relationship: From human blood to social policy. New Press.
Trimeloni, L., & Spencer, J. (2016). Diagnosis and management of breast milk oversupply. The Journal of the American Board of Family Medicine, 29(1), 139–142. https://doi.org/10.3122/jabfm.2016.01.150164
Warwick, R. M., Chapman, J., Pruett, T. L., & Wang, H. (2013). Globally consistent coding systems for medical products of human origin. Bulletin of the World Health Organization, 91(5), 314–314A. https://doi.org/10.2471/BLT.12.116988
Weaver, G. (2015). Under the spotlight: The Queen Charlotte's Hospital Milk Bank at 75. Infant, 11(1), 20–23.
WHO. (2010). WHO Guiding Principles on Human Organ, Cells and Tissue Transplantation. Retrieved November 24, 2022, from: https://apps.who.int/iris/bitstream/handle/10665/341814/WHO-HTP-EHT-CPR-2010.01-eng.pdf?sequence=1
WHO. (2015). Principles for global consensus on the donation and management of blood, blood components and medical products of human origin. Decision EB136(2). Executive Board, 136th session. Retrieved November 24, 2022, from: https://apps.who.int/iris/handle/10665/273230.
WHO. (2022). WHO recommendations for care of the preterm or low‐birth‐weight infant. https://www.who.int/publications/i/item/9789240058262
Wong, T. (2017). Cambodia breast milk: The debate over mothers selling milk. BBC. Retrieved February 3, 2022, from: https://www.bbc.co.uk/news/world-asia-39414820

Auteurs

Marisa Herson (M)

Bioethics and Professionalism Department, Faculty of Health, School of Medicine, Deakin University, Geelong, Australia.

Gillian Weaver (G)

Human Milk Foundation, Rothamsted Research, Harpenden, Hertfordshire, UK.

Classifications MeSH