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Vigilance and Surveillance |
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Saturday, 09 December 2006 |
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A key aspect of any safety and quality regulatory system is the monitoring and communication of adverse events and reactions. The definitions of ‘adverse event’ and ‘adverse reaction’ in the EU context are provided in Directive 2004/23/EC and requirements for reporting are included in the second daughter directive, Directive 2006/86/EC. The Eustite project has developed tools to support a standard system for the definition and classification of adverse events and reactions potentially caused by quality or safety deficiencies in the tissues or cells procured from donors and applied to patients. The proposal includes criteria for the reporting of adverse events and tools for the assessment of Severity, Imputability and Impact. It also provides guidance on responsibilities of key organisations and the appropriate lines of communication that should be maintained. The project has examined systems in place in EU Member States and also in other parts of the World. The report on V&S Existing Systems was finalized in mid December 2007 and it is now available in this website. (Download the Existing Systems Report here). The significant role of WHO in this part of the project ensures that proposals are consistent with glossaries and tools in use or under development around the globe. Under the leadership of WHO, an V&S Medical Advisory Committee has been established and various key experts have participated in the work of the group. (To read more about this Expert Committee, click on V&S MAC on the side-bar). Starting in July 2008, a surveillance pilot was run with the participation of 22 Competent Authorities in 20 Member States. The purpose of the pilot was to assess the feasibility of applying the proposed tools and guidance. You can download here a copy of the proposed Tools as a .pdf file. Vigilance and Surveillance - Tools and Guidance
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Last Updated ( Monday, 27 July 2009 )
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