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Saatja: <[email protected]> Saadetud: 31.03.2023 10:46 Adressaat: <[email protected]> Koopia: <[email protected]>; <[email protected]> Teema: Invitation: Survey of state of Organs vigilance and pilot of Organ SAE/SAR data collection 2023 (2022 data) Dear national competent authorities for organs, This is to inform you of an EU-wide about the state of Organs SAE/SAR reporting in your member states. All Organs National Competent Authorities are kindly requested to respond to this survey by 31 May 2023. Your information is important, even if you are not able to participate in the voluntary pilot data collection exercise. In addition, we are glad to inform you of the launch of the pilot of European level submission of nationally collected Serious Adverse Events and Serious Adverse Reactions, as required under the Organs Directive 2010-45. The pilot is being conducted under the auspices of the department of Substances of Human Origin (SoHO) of the European Commission, by the Vigilance Expert Subgroup (VES) of the expert group of National Competent Authorities (NCA). The attached pilot summary provides background information. We now invite you (if you are able to do so) to submit your national level Organ SAE/SAR data using the tables (1, 2a, 2b) in the attached Excel file. This invitation is being sent to you as NCA. Please forward it with the attached documents to your delegated body if they will be participating on your countrys behalf and inform SANTE-SoHO of the relevant contact details. Deadline for SARE submission (NCA or delegated body): 31 May 2023. If you have any questions, do not hesitate to contact us at Best regards, The SoHO team. European Commission DG SANTE (Health and Food Safety) Unit D2 Medical Products: quality, safety, innovationOffice address: Rue Breydel 2, 06/004, B-1049 Brussels/Belgium Summary of Organ SAE/SAR and living donor SAR reporting pilot (2022-2023) Methods: • Voluntary basis • pilot of European level submission of nationally collected Serious Adverse Events and Serious Adverse Reactions, as required under the Organs Directive 2010-45 Time period • Data collecting time 01/01/22 until 31/12/22 • Submission by NCAs implicated in spring 2023 – deadline 31 May 2023 Objectives of the pilot • Overview of European vigilance data that are notified to NCA or delegated bodies • Obtain insights relevant for reaching the future goal of an annual report for the European countries Coordination: Vigilance Expert Subgroup of the NCA (VES) Principles of SAE/SAR reporting and anticipated benefits • Objective work-up of serious undesired events in transplantation medicine according to the existing law, together with experts of different medical specialties (e.g., quality assurance in a highly advanced medical field) • Constructive and confident communication between all institutions involved in the specific donation process (“no shame and blame “); conclusions and learning should be acceptable for everybody involved in the work-up • Cases: (national level) what can be learned from the case medically and logistically? Which process can be improved for future recipient safety? • Data collection should be internationally comparable to optimize processes and perform risk stratifications Anticipated learning from the proposed pilot reporting exercise • Are participating MS able to collect and learn from national level Organs SAE/SAR? • What additional definitions/tools are required to support this, in the interests of strengthening safety and availability of organs transplantation? Data to be reported from the countries (see Tables 1, 2a/ 2b, 3 and additional guidance below) • Number of SAE and SAR cases per country in relation to the number of organ donors/transplantations • Number of transmitted diseases • Categorized SAR: • Only proven and probable cases • SARs in donors are also to be collected. EU Organ SAE/SAR reporting pilot, 2022-2023 Pilot Summary, tables finalized March 2023 Table 1 Numbers of donors and transplanted organs in 2022 Data for your MS Kidney Liver Pancreas Lung Heart Total no. of in 2022 donors No. of deceased (D) donors No. of living (L) donors Data for your MS Kidney Liver Pancreas Lung Heart Total no. of in 2022 donors No. of organs transplanted (D) No. of organs transplanted (L) Total no. of organs (Automatically calculated) transplanted Table 2a Numbers of reported recipients SAR/SAE (organs procured from deceased donors) including those relating to multi-organ transplants Data for your MS Kidney Liver Pancreas Lung Heart Total no. of in 2022 donors implicated in the reported SAR No. of affected recipients No. of SAR Infectious (viral)* No. of SAR Infectious (bacterial)* No. of SAR Malignancy* No. of SAR Others Total No. of (please specify in SAR/SAE comments)* No. of SAR (total)* (Automatically calculated) No. of SAE# *Includes only confirmed or probable SAR cases (imputability level 3 or 2). In relation to SAR, the CA in the MS where the organ originated and where the reaction occurred should communicate with each other. They should include in their respective reports only the affected recipients and reactions that occurred in their own country. # All SAE cases to be reported by the country where the SAE originated. Include SAE from the whole chain, from deceased donors to transplantation. EU Organ SAE/SAR reporting pilot, 2022-2023 Pilot Summary, tables finalized March 2023 Table 2b Numbers of reported recipients SAR / SAE (organs procured from living donors) including those relating to multi-organ transplants Data for your Kidney Liver Lung Total no. of donors MS in 2022 implicated in the reported SAR No. of affected recipients No. of SAR Infectious (viral)* No. of SAR Infectious (bacterial)* No. of SAR Malignancy* No. of SAR Total no. of Others* (please SAR/SAE specify in comments) No. of recipient SAR (total) (Automatically calculated) No. of SAE# * Includes only confirmed or probable SAR cases (imputability level 3 or 2). # All SAE cases to be reported by the country where the SAE originated. Include SAE from the whole chain, from living donors to transplantation. Table 3 Numbers of reported SAR in donors Data for your MS Kidney Liver Lung Total no. of Total no. of in 2022 SAR/E donors affected by the reported SAR SAR in donors* * Includes only confirmed or probable SAR cases (imputability level 3 or 2). Guidance to support a common approach during the pilot SAE – Serious Adverse Event means 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. An SAE is strictly connected to findings in the donor or donor organs (not in the recipient). It bears a certain risk for the organ recipient, though. Therefore, to classify a finding as an SAE: at the time of detection and communication of the finding, at least one recipient of the donor must have been transplanted or at least anesthetized for transplantation. Examples: infection (pathogen found in kidney perfusion fluid), malignancy (lung tumour found in donor autopsy), HLA-forbidden antigen (not tested in donor). EU Organ SAE/SAR reporting pilot, 2022-2023 Pilot Summary, tables finalized March 2023 SAR – Serious Adverse Reaction means 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. A SAR occurs in the organ recipient or the living donor. A recipient SAR is a” reaction” of the patient during or after transplantation which is suspected to be caused by the donor organ. Therefore, all other recipients of the same donor have a risk to show a similar reaction. Examples: infection (recipient with positive HCV-PCR after transplant), malignancy (recipient with metastases of glioblastoma in the lung, no own primary tumour), autoimmune disease (liver recipient with new Wilson’s disease post-transplant) etc. Living donor reactions – any SAR(s) in the living donor that may result from the donation. • All SAE / SAR cases may be collected, reviewed, and analysed at national level. • Only reactions which are reasonably considered to have been caused by the transplanted organ and linked to the quality and safety of the organ or to the procurement in the case of a living donor reaction, should be included in the pilot. o Imputability 2 Likely / Probable - When the evidence is clearly in favour of attributing the adverse reaction to the quality/safety of the organ (for recipients) or to the donation process (for living donors). o Imputability 3 Definite/ Certain - When there is conclusive evidence beyond reasonable doubt for attributing the advrse reaction to the quality/safety of the organ (for recipients ) or to the donation process for (for donors) General • Include cases which have been finalised by the reporting deadline. Cases from a previous year which were still under investigation during the pilot reporting year, can be included on voluntary basis if they were finalised before the reporting deadline. • When a SAE results in a reportable SAR in an organ recipient or donor, only the SAR, not the SAE, should be reported. Questionnaire At the time of submission of pilot data, all Member State NCA will be sent a survey about the current state of reporting to the CA or delegated body and asked to respond about aspects needing better clarification and/or barriers to collecting/learning from the data. EU Organ SAE/SAR reporting pilot, 2022-2023 Pilot Summary, tables finalized March 2023