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Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning

World Health Assembly Resolution 63.22 mandated World Health Organization to facilitate Member State access to appropriate information on medical products of human origin (MPHO), including collecting data on serious adverse events and reactions. To meet this challenge, the Italian National Transplan...

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Detalles Bibliográficos
Autores principales: Petrisli, Evangelia, Carella, Claudia, Navarro, Aurora, Fehily, Deirdre, Strong, Douglas Michael, Cardillo, Massimo
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Lippincott Williams & Wilkins 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8376274/
https://www.ncbi.nlm.nih.gov/pubmed/33449611
http://dx.doi.org/10.1097/TP.0000000000003589
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author Petrisli, Evangelia
Carella, Claudia
Navarro, Aurora
Fehily, Deirdre
Strong, Douglas Michael
Cardillo, Massimo
author_facet Petrisli, Evangelia
Carella, Claudia
Navarro, Aurora
Fehily, Deirdre
Strong, Douglas Michael
Cardillo, Massimo
author_sort Petrisli, Evangelia
collection PubMed
description World Health Assembly Resolution 63.22 mandated World Health Organization to facilitate Member State access to appropriate information on medical products of human origin (MPHO), including collecting data on serious adverse events and reactions. To meet this challenge, the Italian National Transplant Center, with a mandate from World Health Organization, has built and maintained an open-access searchable database of instructive records on disease transmission and other MPHO adverse occurrences. METHODS. One record in the Notify Library describes a specific type of adverse occurrence in 1 type of MPHO and might be linked with 1 or multiple different references. The record inclusion criteria are that it has been reliably documented in a published article or official vigilance reporting system and that it has instructive value for the fields of transfusion, transplantation, or assisted reproduction. The selection and review of references for publication is performed by international experts who collaborate in 5 topic-specific editorial groups: infection transmission, malignancy transmission, living-donor reactions, process-related incidents, and clinical complications. New relevant references are identified through systematic searches and proactive communication by the experts. RESULTS. The Library contains 1733 records, quoting 2632 references. Of the records, 41.8% are related to organs, 20.8% to blood and blood components, 16.5% to hematopoietic progenitor cells, 15.2% to tissues, 4.2% to reproductive tissues and cells, and 1.5% to other MPHO. CONCLUSIONS. Notify Library is the first open-access, searchable database of systematically identified reports of disease transmission and other adverse occurrences arising from the donation and clinical application of MPHO.
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spelling pubmed-83762742021-09-01 Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning Petrisli, Evangelia Carella, Claudia Navarro, Aurora Fehily, Deirdre Strong, Douglas Michael Cardillo, Massimo Transplantation Reviews World Health Assembly Resolution 63.22 mandated World Health Organization to facilitate Member State access to appropriate information on medical products of human origin (MPHO), including collecting data on serious adverse events and reactions. To meet this challenge, the Italian National Transplant Center, with a mandate from World Health Organization, has built and maintained an open-access searchable database of instructive records on disease transmission and other MPHO adverse occurrences. METHODS. One record in the Notify Library describes a specific type of adverse occurrence in 1 type of MPHO and might be linked with 1 or multiple different references. The record inclusion criteria are that it has been reliably documented in a published article or official vigilance reporting system and that it has instructive value for the fields of transfusion, transplantation, or assisted reproduction. The selection and review of references for publication is performed by international experts who collaborate in 5 topic-specific editorial groups: infection transmission, malignancy transmission, living-donor reactions, process-related incidents, and clinical complications. New relevant references are identified through systematic searches and proactive communication by the experts. RESULTS. The Library contains 1733 records, quoting 2632 references. Of the records, 41.8% are related to organs, 20.8% to blood and blood components, 16.5% to hematopoietic progenitor cells, 15.2% to tissues, 4.2% to reproductive tissues and cells, and 1.5% to other MPHO. CONCLUSIONS. Notify Library is the first open-access, searchable database of systematically identified reports of disease transmission and other adverse occurrences arising from the donation and clinical application of MPHO. Lippincott Williams & Wilkins 2021-08-19 2021-09 /pmc/articles/PMC8376274/ /pubmed/33449611 http://dx.doi.org/10.1097/TP.0000000000003589 Text en Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. https://creativecommons.org/licenses/by/4.0/This is an open access article distributed under the Creative Commons Attribution License 4.0 (CCBY) (https://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Reviews
Petrisli, Evangelia
Carella, Claudia
Navarro, Aurora
Fehily, Deirdre
Strong, Douglas Michael
Cardillo, Massimo
Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning
title Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning
title_full Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning
title_fullStr Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning
title_full_unstemmed Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning
title_short Vigilance for Medical Products of Human Origin—Progress on the Notify Library’s Global Effort to Share Information and Learning
title_sort vigilance for medical products of human origin—progress on the notify library’s global effort to share information and learning
topic Reviews
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8376274/
https://www.ncbi.nlm.nih.gov/pubmed/33449611
http://dx.doi.org/10.1097/TP.0000000000003589
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