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SAEARs reporting under the EU ODD

SAEARs reporting under the EU ODD. 11 October 2011 Hazel Lofty, Regulation Manager . Questions. What do we have to report? Why do we have to report it? What will be done with the information? How do we report it?. What is reportable? . Serious Adverse Event (SAE)

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SAEARs reporting under the EU ODD

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  1. SAEARs reporting under the EU ODD 11 October 2011 Hazel Lofty, Regulation Manager

  2. Questions • What do we have to report? • Why do we have to report it? • What will be done with the information? • How do we report it?

  3. What is reportable? Serious Adverse Event (SAE) Any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity.

  4. What is reportable? Serious Adverse Reaction (SAR) An unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation or morbidity.

  5. Directive requirements Reporting of: • SAE that may influence the quality and safety of organs that may be attributed to the testing, characterisation, procurement, preservation and transport of organs; • SAR observed during/after transplantation which may be connected to those activities. • The management measures taken

  6. Directive requirements Endeavour to follow-up living donors in order to identify, report and manage: • Any event potentially relating to the quality and safety of the donated organ • Any serious adverse reaction in the living donor that may result from the donation.

  7. Why do we need to report? • Better information on adverse events • Trend monitoring • Potential to reduce the risk of SAEARs • Feedback to the sector • (Legal requirement)

  8. What will be done with the information? • Recall, information cascade where necessary • Investigation: Improvement (RCA and CAPA) • Inform inspection/audit • Monitoring of trends & data gathering

  9. How? • Online reporting system where SAEARs submitted to NHSBT, HTA to be informed via NHSBT • NHSBT to lead management and investigation of organ related SAEARs • HTA retain oversight as CA

  10. Summary • Build a system • Accurate • Rapid • Verifiable • Work together • Refine reporting requirements • Best use of gathered data

  11. www.hta.gov.uk http://twitter.com/HTA_UK http://www.Facebook.com/HumanTissueAuthority

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