Learning from incidents in medically assisted reproduction: the Notify Library as a learning tool.

Biovigilance Medically assisted reproduction (MAR) Notify Library Serious adverse event Serious adverse reaction

Journal

Reproductive biomedicine online
ISSN: 1472-6491
Titre abrégé: Reprod Biomed Online
Pays: Netherlands
ID NLM: 101122473

Informations de publication

Date de publication:
Oct 2021
Historique:
received: 08 01 2021
revised: 14 07 2021
accepted: 19 07 2021
pubmed: 2 9 2021
medline: 10 2 2022
entrez: 1 9 2021
Statut: ppublish

Résumé

Biovigilance is the systematic monitoring of serious adverse reactions and events (SARE) that ensures the quality and safety of tissues and cells for human application in medically assisted reproduction (MAR). The Notify Library is an open access database launched by the World Health Organization and supported by the Italian National Transplant Centre (CNT) that has collected information on documented adverse occurrences in transplantation, transfusion and MAR. It is not a SARE register, but rather a collection of SARE types identified primarily by review of published articles and case reports from national or regional vigilance programmes. The Notify Library includes many well-documented records of adverse occurrences in MAR treatment, representing a useful tool for MAR operators in the evaluation of the risks associated with the clinical application of reproductive tissues and cells. It is updated with new records when a new type of incident is reported for the first time. All incident types described might have teaching value during the risk management carried out by a MAR centre. Sharing lessons learned from these incidents represents an important didactic opportunity that can help MAR centres to improve their processes and to achieve higher standards of quality and safety.

Identifiants

pubmed: 34465527
pii: S1472-6483(21)00358-8
doi: 10.1016/j.rbmo.2021.07.015
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

581-585

Informations de copyright

Copyright © 2021 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Auteurs

Alessandra Alteri (A)

Obstetrics and Gynaecology Unit, IRCCS San Raffaele Scientific Institute, Milan 20132, Italy. Electronic address: alteri.alessandra@hsr.it.

Evangelia Petrisli (E)

Operative Unit of Microbiology, Department of Specialized, Experimental and Diagnostic Medicine, IRCCS St. Orsola-Malpighi Polyclinic,, University of Bologna, Bologna, Italy.

Paula Nolan (P)

Human Fertilisation and Embryology Authority (HFEA), London, UK.

Valerio Pisaturo (V)

Obstetrics and Gynaecology Department, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.

Deirdre Fehily (D)

DG Santé, European Commission, Brussels, Belgium (currently on secondment from the Italian National Transplant Centre).

Aurora Navarro (A)

Biovigilance, Organizació Catalana de Trasplantaments, Barcelona, Spain.

D Michael Strong (DM)

Department of Orthopaedics and Sports Medicine, University of Washington, School of Medicine, Seattle, Washington, USA.

Massimo Cardillo (M)

Italian National Institute of Health - Italian National Transplant Centre, Rome, Italy.

Mauro Costa (M)

Reproductive Medicine Department, International Evangelical Hospital, Genoa, Italy.

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Classifications MeSH