1.3 The vigilance and surveillance chain for medical products of human origin, a NOTIFY guide

This guidance aims to provide a didactic overview of V&S for MPHO targeting clinicians and health authorities. In order to facilitate its use, the booklet has been divided in chapters, each addressing an aspect of V&S for MPHOs.  It demonstrates the necessity, and the potential, of V&S to improve practices and therefore the paramount importance of V&S for MPHO. The NOTIFY booklet provide examples which demonstrate the improvement of the care of both the recipients and donors, from the recognition and diagnosis of adverse reactions to the appropriate investigations and treatment after having drawn upon the references in the NOTIFY Library (www.notifylibrary.org). The success is the reflection of the work of the all the professionals who have contributed to the NOTIFY Library.  Many of their recommendations for good practice have been published in a report of a NOTIFY consultation in Bologna in 2011 and in a series of guidance documents developed within the European Union (EU)-funded SOHO V&S Project (Vigilance and Surveillance of Substances of Human Origin) which collaborated in the organization of that consultation.

Initially, the NOTIFY booklet was to be focused on cells, tissue and organs for transplantation, as well as gametes and embryos for assisted reproduction (ART). As the NOTIFY project is now expanding to cover all MPHO, blood and blood products, the scope of the booklet will be expanded to include these in the future. This is a work in progress; it should not be seen as a finished outcome, but as an evolving document where users can both learn from the guidance or contribute to improvement. The mechanism that characterizes the NOTIFY project, editorial workgroups of volunteer experts and support from national authorities, as well as scientific and professional societies, applies to the development of the booklet. Proposals for improvement will be assessed and edited by the NOTIFY team, with the help of a panel of experts, and will eventually be integrated to the booklet.

The structure of this document was designed for accessibility via the Internet where sections (links) can be consulted independently and adapted to the needs of the user. Effective V&S requires many players to collaborate together, each one fulfilling their particular role: clinicians detecting and reporting adverse outcomes in recipients; donation professionals detecting and reporting adverse outcomes in donors; technical personnel detecting and reporting errors and mistakes in processing, storage and delivery; multi-skilled teams investigating causes and defining corrective and preventive actions and responsible individuals or organizations publishing vigilance information to help others to learn from the cases and to prevent recurrence elsewhere.  This document addresses each step in the vigilance chain as a link –to the links can be added to one another and constitute a chain. Like a chain, thanks to the effort of all stakeholders, V&S for MPHOs has the power to be the driver of excellence from donation to clinical application. To access the any section in this document, click on the link in the list below.