First Global Vigilance and Surveillance (VS) Initiative: The WHO Notify Library. (August 2017)

• Record Type: Journal Article
• Authors: Navarro Martínez-Cantullera, Aurora; Carella, Claudia; Petrisli, Evangelia; Minutoli, Daniela; Fehily, Deidre; Strong, Douglas Michael; Noel, Luc; Ushiro-Lumb, Ines; Nalesnik, Michael; Shaw, Bronwen; Withaker, Barbee; Brubaker, Scott A.; Tort, Jaume; Carmona Sanz, Mar; Dominguez-Gil, Beatriz; Nuñez, Jose Ramon; Nanni Costa, Alessandro
• Is Part Of: Transplantation. Volume 101(2017)Supplement 8S-2
• Publication Date: 2017-08
• Subjects: Transplantation of organs, tissues, etc -- Periodicals; Transplantation immunology -- Periodicals; 617.95
• DOI: 10.1097/01.tp.0000525131.94986.27
• Languages: English
• ISSNs: 0041-1337

Abstract

Abstract : Introduction: In 2010 WHO adopted Resolution WHA 63.22 which recognises the need for surveillance of adverse occurrences (AO) in the therapeutic use of organ, tissues and cells and requests Member States to have appropriate information on the donation, processing and transplantation of human cells, organs and tissues, including data on AO. Subsequently, WHO and the Italian National Transplant Center (CNT) joined forces to organise a major global initiative aiming to create a free access database of published AO, the Notify Library. The website was created to share V&S information among professionals with the focus on didactic value and to support the development of such programs worldwide. In 2015 the Spanish and Catalan Transplant Organizations (ONT-OCATT) joined efforts with WHO and CNT to promote and develop the library. Material and methods: A bibliographic search for different AO types was established in 2012. There are five editorial groups; infections, malignancies, living donor, clinical complications and processing. AO are categorised as harm to recipient/donor and risk of harm. Didactic cases are described according to alerting signals, latency, frequency, source imputability and expert comments Results: The Library contains 1523 didactic records from 2370 published references. They are classified by MPHO type: 563 Organs; 319 blood; 289 cells; 259 tissues, 69 reproductive and 24 others. From the 563 organ-related records there are 240 involving kidneys (41%), 188 liver (32%), 59 lung (10%), 44 heart (8%), 17 multi-organ (3%), 11 pancreas (2%) and 4 small bowel (1%). 51% were infection-related (96 viral, 90 bacterial, 72 parasitic and 30 fungal), with 26% records on transmissions of malignancy. Conclusions: The Notify Library is an extensive compilation of high-quality educational material and information on MPHO AO. Its main objective is to offer expert analysis from editorial group members regarding adverse occurrences that have been published in the literature or recorded in official vigilance programs, in order to support safer transfusion, transplantation and assisted reproduction programs. The involvement of international experts from multidisciplinary backgrounds is aimed at ensuring the quality and reliability of the Library's content and promotes the involvement of health professionals, competent authorities and scientific societies working on V&S across the globe. References: 1. Fehily D. Sharing Vigilance experience and knowledge globally: a preliminary overview of the notify library. Organs, tisuses and cells 2013; (16), 117-125. 2. Dubord PJ. Eye banking and corneal transplantation communicable adverse incidents: current status and project Notify. Cornea 2013; Aug;32(8):1155-66. 3.Hinsenkamp M. Adverse reactions and events related to musculoskeletal allografts: reviewed by the World Health Organization's project Notify. International Orthopaedics (SICOT) 2012; 36:633-641. 4. Fehily D. Vigilance: lessons learned from the tissue and cell experience in the EU. Part 1. reporting and communication. Organs, tissues and cells 2013;(16) 165–173.