ABM is responsible for vigilance and surveillance in the field of Assisted Reproduction in France. It publishes annual reports from the programme. Many cases are referenced in the NOTIFY library records.
Background Documents
VIGILANCE AND SURVEILLANCE REPORTS
| Attachment | Size |
|---|---|
 ABM_rapport_de_biovigilance_2017.pdf | 4.6 MB |
| ABM rapport_ampvigilance_2012_ministre_vfinale.pdf | 2.18 MB |
| ABM rapport_ampvigilance_2011_ministre_v7_1_.pdf | 2.28 MB |
| ABM rapport_ampvigilance_2010_ministre_vf.pdf | 1.78 MB |
| ABM rapport_ampvigilance_2009.pdf | 350.65 KB |
| ABM rapport-annuel-amp-vigilance 2008.pdf | 264.31 KB |
ANSM gathers serious adverse event and reaction reports for transfusion and transplantation from the whole of France and publishes summaries in Annual Reports. Selected cases of didactic value have been included in the NOTIFY library.
The AABB aims to advance the practice and standards of transfusion medicine and cellular therapies to optimize patient and donor care and safety.
| Attachment | Size |
|---|---|
| TRALI_redefinition 2019 - Transfusion | 206.5 KB |
| TACO_redefinition 2019 - Lancet | 96.77 KB |
| 2012-2017 AABB Donor Hemovigilance Highlights | 893.77 KB |
| 2012-2014 AABB Donor Hemovigilance Report | 982.15 KB |
| Revised Standard 2014 Surveillance of Complications Related to Blood Donation.pdf | 300.95 KB |
| AABB-donor-hemovigilance-report-2012.pdf | 1.28 MB |
The Australian Vigilance and Surveillance System for Organ Donation and Transplantation provides a national framework for the reporting of adverse events and reactions in the Australian donation and transplantation system.
| Attachment | Size |
|---|---|
| OTA_2021 annual report | 798.58 KB |
The Deutsche Stiftung Organtransplantation (DSO) is the organization responsible for coordinating organ donation in Germany.
| Attachment | Size |
|---|---|
| Vigliance data in organ donation and Transplantation in Germany (2016-2022) | 1.08 MB |
The European Commission (Directorate General for Health and Food Safety) receives annual vigilance reports for different MPHO types from the Competent Authorities of its 27 Member States. It publishes collated summaries of these reports.
| Attachment | Size |
|---|---|
| 2022 SARE Blood_summary | 1.74 MB |
| 2022 SARE Tissues and Cells_summary | 2.27 MB |
| 2020 SARE Blood summary | 1.04 MB |
| 2020 SARE Tissues and Cells summary | 1.93 MB |
| 2023 RAB_RATC_summary | 222.12 KB |
| 2022 RAB_RATC_summary | 350.85 KB |
| 2021 RAB_RATC_summary | 351.47 KB |
| 2020 RAB_RATC_summary | 368.1 KB |
FDA is an agency within the Department of Health and Human Services.The FDA's organization consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods, Global Regulatory Operations and Policy, and Operations.
| Attachment | Size |
|---|---|
| FDA Recommendations Reducing Risk of TT Babesiosis | 205.83 KB |
| FDA Fatality Report-2017 | 238.37 KB |
| FDA Fatality Report-2016 | 265.08 KB |
| FDA Fatality Report-2015.pdf | 812.12 KB |
| FDA Fatality Report-2014.pdf | 122.58 KB |
Catalunya has hemovigilance and biovigilance systems that consists of detecting, recording and analyzing information concerning adverse reactions and events on blood donation and transfusion, organ, tissue and cell donation and transplantation. Annual reports are published.
| Attachment | Size |
|---|---|
| Hemovigilance Report 2022 | 1.23 MB |
| Hemovigliance Report 2020 | 1.43 MB |
| Hemovigilance Report 2018 | 1.28 MB |
| Hemovigliance Report 2016 | 5.53 MB |
| Hemovigliance Report 2015 | 6.44 MB |
| Hemovigliance Report 2014 | 5.65 MB |
| Biovigilance Report 2014 | 820.65 KB |
| Hemovigliance Report 2013 | 861.23 KB |
HFEA is responsible for vigilance and surveillance in the field of Assisted Reproduction in the United Kingdom. In 2014 it published its first annual report from the programme. Cases of didactic value have been included in the NOTIFY library.
The Italian National Blood Centre coordinates the National Blood Information System instituted by specific Ministerial Decree and opeating in the Ministry of Health's New Health Information System.
| Attachment | Size |
|---|---|
| Italian Blood System 2019 - Vol. 1 | 5.96 MB |
The Italian National Transplant Centre (CNT) is a technical body of the Ministry of Health. It manages Transplant Information System which collect data regarding donation, allocation and transplantation of organ including transplanted organ quality, defines protocols about safety and security of organ donation and criteria for operational protocols for organ and tissue allocation, allocation of organs for urgencies and national programs.
| Attachment | Size |
|---|---|
| 2023 Annual Report (ITA) | 9.61 MB |
| 2022 Annual Report (ITA) | 15.02 MB |
| 2021 Annual Report (ITA) | 3.17 MB |
| 2020 Annual Report (ENG) | 2.63 MB |
| 2020 Annual Report (ITA) | 11.89 MB |
| 2019 Annual Report (ITA) | 37.4 MB |
The National Institute of Biologicals (NIB) is an autonomous institute under the administrative control of the Ministry of Health and Family Welfare (MoHFW), Government of India
SHOT is the United Kingdom’s independent, professionally-led haemovigilance scheme. Since 1996 SHOT has been collecting and analysing anonymised information on adverse events and reactions in blood transfusion from all healthcare organisations that are involved in the transfusion of blood and blood components in the United Kingdom. SHOT publishes annual reports summarising the notifications received and the lessons learned. (to see all SHOT Report)
| Attachment | Size |
|---|---|
| SHOT Annual Report 2018 | 15.16 MB |
| SHOT Annual Report 2018 Summary | 4.25 MB |
| SHOT Annual Report 2017 | 12.41 MB |
| SHOT Annual Report 2017 Summary | 2.33 MB |
| SHOT Annual Report 2016.pdf | 13.2 MB |
| SHOT Annual Report 2016 Summary.pdf | 2.23 MB |
| SHOT Annual report 2015.pdf | 7.42 MB |
| SHOT Annual Report 2015 Summary.pdf | 4.14 MB |
| SHOT Annual report 2014.pdf | 2.9 MB |
| SHOT Annual Report 2013.pdf | 2.83 MB |
| SHOT-Annual-Report-2012.pdf | 2.72 MB |
| SHOT Annual Report 2011.pdf | 3.77 MB |
TRIP is a national vigilance organisation in the Netherlands that gathers adverse occurrence reports in transfusion, transplantation and assisted reproduction on behalf of the Dutch Health Authority. It publishes an annual summary of the reports it receives. TRIP collaborates with the NOTIFY library, selecting and analysing cases of didactic value for insertion in the database.
| Attachment | Size |
|---|---|
| TRIP Hemovigilance 2017 | 4.22 MB |
| TRIP Biovigilance 2017 | 1.84 MB |
| TRIP Hemovigilance 2016 | 6.76 MB |
| TRIP Biovigilance 2016 | 2.71 MB |
| TRIP Hemovigilance 2015 | 2.49 MB |
| TRIP Biovigilance 2015 | 3.19 MB |
| TRIP Hemovigilance 2014 | 2.64 MB |
| TRIP Biovigilance 2014 | 1.22 MB |
| TRIP Hemovigilance 2013 | 570.29 KB |
| TRIP Biovigilance 2013 | 1.88 MB |
| TRIP Hemovigilance 2012 | 926.78 KB |
| TRIP Biovigilance 2012 | 733.18 KB |
| TRIP Hemovigilance 2011 | 727.12 KB |
| TRIP Tissue vigilance 2011 | 1.7 MB |
| TRIP Hemovigilance 2010 | 864.38 KB |
| TRIP Tissue vigilance 2010 | 164.86 KB |
| TRIP Hemovigilance 2009 | 507.69 KB |
| TRIP Tissue vigilance 2009 | 581.53 KB |
The WMDA gathers adverse occurrence reports from the professional community worldwide through its Serious Event and Adverse Reaction (SEAR) and Serious Product Event and Adverse Reaction (SPEAR) programmes. It publishes summaries of the cases reported. WMDA collaborates with the NOTIFY library, selecting and analysing cases of didactic value for insertion in the database.
| Attachment | Size |
|---|---|
| WMDA - SEAR Summary_2003-2010 | 1.28 MB |
| WMDA - SEAR Annual Report 2011 | 67.35 KB |
| WMDA - SEAR Annual Report 2013 | 84.67 KB |
| WMDA - SEAR Annual Report 2014 | 100.77 KB |
| WMDA - SEAR Annual Report 2016 | 157.27 KB |
| WMDA - SEAR Annual Report 2017 | 169.41 KB |
| WMDA - S(P)EAR Annual Report 2015 | 724.48 KB |
| WMDA - S(P)EAR Annual Report 2018 | 1.05 MB |
| WMDA - S(P)EAR Annual Report 2019 | 360.45 KB |
| WMDA - S(P)EAR Annual Report 2020 | 2.11 MB |
| SEAR-Rapid-Alert #1 | 100.46 KB |
| SEAR-Rapid-Alert #2 | 134.67 KB |
| SEAR-Rapid-Alert #3 | 190.15 KB |
| SEAR-Rapid-Alert #4 | 372.98 KB |
| SEAR Memo | 61.8 KB |
| WMDA Information | 76.69 KB |
VIGILANCE GUIDANCE DOCUMENTS
AATB is the premier standard-setting body promoting the safety and use of donated human tissue-
The latest AATB bulletin on Requirements and Recommendations for Reducing Risk of Mycrobacterium tubercolosis Transmission (August 7, 2023) is availabe at the following link and downloadable in print/pdf version here below.
The American Society of Transplantation is an organization dedicated to advancing the field of transplantation and improving patitne care by promoting research, education, advocacy, organ donation and service to the community.
| Attachment | Size |
|---|---|
| The indipendent living donor advocate - a guidance document (2015) | 71.83 KB |
| Report of the Vancouver Forum (2006) | 480.97 KB |
| Amsterdam Consensus statement (2004) | 98.32 KB |
EDQM is the Council of Europe Directorate for the Quality of Medicines & HealthCare coordinating the transplantation and transfusion-related activities. Documents are available at the following links:
8t Edition of the Guide to the quality and safety of organs for transplantation (2022)
5th Edition of the Guide to the quality and safety of tissues and cells for human application (2022)
21st edition of the Blood Transfusion Guide (2023)
The Declaration clarifies the issues of transplant tourism, trafficking and commercialism and provides ethical guidelines for practice in organ donation and transplantation
| Attachment | Size |
|---|---|
| 2018 Declaration of Istanbul.pdf | 213.99 KB |
EFRETOS was an EU-funded project that aimed to describe the optimal content of a European Transplant Registry, including an appropriate functional framework, a feasible technical approach and the organisational prerequisites. It also aimed to provide a comprehensive approach to safety issues related to organ transplantation, including the development of an organ vigilance system. The final project deliverable includes a section (chapter 10) on organ vigilance.
| Attachment | Size |
|---|---|
| EFRETOS Recommendations on Organ Vigilance.pdf | 1.14 MB |
The main aim of ESHRE is to promote interest in, and understanding of, reproductive biology and medicine.
| Attachment | Size |
|---|---|
| Medically assisted reproduction in patients with a viral infection or disease | 7.65 MB |
EUSTITE was an EU-funded project (2006-2009) led by the Italian National Transplant Centre in which the World Health Organisation participated. In one of its work-packages, it conducted the first pilot programme of collecting and analysing adverse occurrences associated with tissues and cells used in transplantation and assisted reproduction in 20 EU Member States. Many of the cases evaluated in the pilot study have been inserted in the NOTIFY library.
| Attachment | Size |
|---|---|
| EUSTITE Final Recommendations.pdf | 169.98 KB |
| EUSTITE V&S Pilot Report.pdf | 1.38 MB |
| EUSTITE Vigilance Tools Wallchart.pdf | 116.87 KB |
| EUSTITE_InspectionGuidelines_Final Edit_July08_v2.pdf | 264.86 KB |
This document is part of the joint action ‘785269/GAPP’, which has received funding from the European Union’s Health Programme (2014-2020).
The main scope of the guideline is to define how a PPA programme should or could be organised. This document provides recommendations to Competent Authorities to have a common approach for a Preparation Process Authorisation (PPA). For that, different steps are described throughout the guideline to assess the PPA.
The Global Alliance of Eye Bank Associations inc. is an internationally recognized association of eye bank associations. The Global Alliance supports the WHO’s Initiative for Medical Products of Human Origin, SDS/HIS (Special Service Delivery) and the Declaration of Istanbul on Organ Trafficking and Transplantation Tourism.
| Attachment | Size |
|---|---|
| Global Alliance of Eye Bank Associations | 804.33 KB |
The International Haemovigilance Network was formed in 2009 and consists of national, operational haemovigilance systems that join the group on behalf of their country. It provides a forum for sharing best practice and benchmarking of data, as well as a resource for existing and new haemovigilance systems.
The International Society of Blood Transfusion is a scientific society founded in 1935 where transfusion medicine professionals from over 100 countries come together to share knowledge and promote education to improve the safety of blood transfusion worldwide.
The National Blood Centre is the technical body of the Italian Ministry of Health for all transfusion activities.
| Attachment | Size |
|---|---|
| Guidelines for hemovigilance reporting in the Transfusion Information System (ITA) | 4.18 MB |
| Attachment | Size |
|---|---|
| The Notify Booklet - v2 2018 | 899.15 KB |
| The Notify Booklet - v1 2014 | 579.06 KB |
| Notify exploring vigilance notification for organs, tissues and cells, Notify Group, Bologna, p.133, (2011).pdf | 2.56 MB |
| Attachment | Size |
|---|---|
| FR Request for Information Biovigilance.pdf | 177.38 KB |
| US Biovigilance Efforts to Bridge Gap DHSS.pdf | 4.9 MB |
Vigilance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation (VISTART)
VISTART (Vigilance and Inspection for the Safety of Transfusion, Assisted Reproduction and Transplantation) was an European Union co-funded Joint Action (GA/676969) led by the Italian National Transplant and Blood Centres. One of its work-packages focuses on increasing the involvement of EU Member States Competent Authorities in the Notify Library to enhance the sharing of vigilance information.
| Attachment | Size |
|---|---|
| VISTART: Guidelines on Horizon Scanning | 3.08 MB |
| VISTART: A user guide for Competent Auhorities | 1.71 MB |
SOHOV&S was an EU-funded project (2009 – 2012) that developed a number of guidance documents for vigilance and surveillance of tissues and cells for transplantation and for assisted reproduction.
WMA is an international organization representing physicians. It was founded in 1947. The WMA promotes the highest possible standard of medical ethics and provides ethical guidance to physicians through its Declarations, Resolutions and Statements.
WUTBA was established in 2005 as a collaborative effort among the current international peak bodies in tissue and cell banking, to promote the access to safe and high quality donated human tissue grafts worldwide.
| Attachment | Size |
|---|---|
| WUTBA Guide on how to establish tissue donation and banking | 764 KB |
WORLD HEALTH ORGANISATION (WHO) AND WORLD HEALTH ASSEMBLY (WHA)
RECOMMENDATIONS FOR EPIDEMIC DISEASE OCCURRENCE›Zika virus (ZIKAV)
| Attachment | Size |
|---|---|
| NOTA+TÉCNICA+ANVISA ZIKA 16 marzo 2016.pdf | 91.9 KB |
| http_portal.anvisa.gov_.br_wps_content_anvisa+portal_anvisa_sa.pdf | 77.35 KB |
The CDC is one of the major operating components of the Department of Health and Human Services in America
| Attachment | Size |
|---|---|
| Zika_Virus_-10_Public_Health_Achievements_in_2016.pdf | 4.99 MB |
| Attachment | Size |
|---|---|
| zika risk assessment 9 april 2019 | 814.92 KB |
| zika-virus-rapid-risk-assessment-23-february-2016.pdf | 645.97 KB |
| July 2016 Zika-virus-safety-of-substances-of-human-origin.pdf | 1 MB |
The European Commission (Directorate General for Health and Food Safety) dedicated page on the emerging viral disease Zika is available at the following link http://ec.europa.eu/health/zika/index_en.htm
| Attachment | Size |
|---|---|
| Outbreak of Zika Virus Disease - European Commission.pdf | 69.73 KB |
| Attachment | Size |
|---|---|
| HCTP_ZIKA_Virus_Guidance_05-02-2018.pdf | 85.9 KB |
| Zika Blood Guidance_July 2018.pdf | 222.25 KB |
| Attachment | Size |
|---|---|
| Zika_virus_and_Transplantation_of_Solid_Organs_from_Deceased_Donors.pdf | 27.05 KB |
| Attachment | Size |
|---|---|
| ONT - RECOMENDACIONES VIRUS ZIKA.pdf | 154.4 KB |
RECOMMENDATIONS FOR EPIDEMIC DISEASE OCCURRENCE›SARS-CoV-2
| Attachment | Size |
|---|---|
| NOTA TÉCNICA Nº 25/2020-CGSNT/DAET/SAES/MS (Portuguese) | 220.55 KB |
AABB Coronavirus resources are available at the link
Further information on Convalescent Plasma can be found on Covidplasma.org
| Attachment | Size |
|---|---|
| COVID-19 Convalescent Plasma Resources | 185.34 KB |
| Attachment | Size |
|---|---|
| Patient Management and Clinical Recommendations During the Coronavirus (COVID-19) Pandemic | 690.67 KB |
COVID19: Organ Donation and Transplantation Town Hall webinar #1 (March 23, 2020); webinar #2 (April 13, 2020); webinar #3 (May 11, 2020).
Special module on Donor and transplant issue (April 17, 2020)
| Attachment | Size |
|---|---|
| 2019-nCoV (Coronavirus): FAQs for Organ Transplantation (update May 5. 2020) | 76.58 KB |
| COVID-19 Information | 374.32 KB |
| Attachment | Size |
|---|---|
| CDNA National guidelines for public health units. | 83.76 KB |
| PHLN Lab Test Guidance SARS-CoV-2 | 448.51 KB |
| FAQs & Advice - Transplantation Society of Australia and New Zeland | 278.89 KB |
| Attachment | Size |
|---|---|
| Contingency Plan for the sustainability and safety of organs, tissues and cells (portuguese) | 393.61 KB |
Daily Risk Assessment on COVID-19
EBMT webinars on COVID 19 are available at this link
| Attachment | Size |
|---|---|
| EBMT COVID-19 guidelines v.8.1.2 May 17, 2020 | 238.25 KB |
updates on ESHRE news and statements and COVID-19 and ART
webinar on COVID-19 and ART recording available at the link
| Attachment | Size |
|---|---|
| SARS-COV-2 and assisted reproduction - Feb 2022 | 88.5 KB |
| Attachment | Size |
|---|---|
| COVID-19 and Eye Tissue Donation March 2 2020 | 197.18 KB |
GAEBA is the Global Alliance of Eye Bank Associations, an internationnaly recognised assicaition of Eye bank association.
| Attachment | Size |
|---|---|
| ALERT UPDATE November 2020 - COVID-19 and Ocular Tissue Donation | 219.29 KB |
Canadian COVID-19 consensus Guidance and update on organ and tissue donation and transplantation services issued by the Canadian Blood Service are available at the professional education link and updated on a weekly basis.
ISBT webinars on COVID-19 and blood supply are available at this link
Latest CNS guidance on SARS-CoV-2 and blood supply are availabe in italian at the link
| Attachment | Size |
|---|---|
| CNS recommendations on SARS-CoV-2 | 138.89 KB |
Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee (JPAC)
JPAC is responsible to issue detailed guidelines for the UK Transfusion Services and to be an Advisory Committee to the UK Transfusion Services
| Attachment | Size |
|---|---|
| Coronavirus Infection.pdf | 56.02 KB |
| Attachment | Size |
|---|---|
| Recommendation on ocular tissue procurement in the context of COVID19 pandemic (French) | 173.13 KB |
Updated info available at the link COVID-19: Advice for clinicians
Organ Procurement and Transplantation Network
Updated Member information on COVID19 are available at the link
Swisstransplant is the Swiss National Foundation for organ Donation and Transplantation. On behalf of the Swiss Federal Office of Public Health it is responsible, as the national office, for the allocation of organs to recipients in accordance with the applicable law, and is in charge of the corresponding waiting list.
| Attachment | Size |
|---|---|
| Covid-19 recommendation - update Feb 2022 | 146 KB |
| COVID-19 vaccination in SOT candidates and SOT recipients - Dec 2021 | 248.82 KB |
| Memorandum SARS-CoV-2 positive recipients - Dec 2021 | 167.61 KB |
A webinar on Tissues donation from deceased donor during COVID-19 pandeminc is organised for April 28th. To see webinar recording register to the link.
| Attachment | Size |
|---|---|
| Presentations | 4.31 MB |
US National Institute of Health COVID-19 treatments giudelines are available at this link
Coronavirus - Impact on registry operation
New guidance on stem cell donation and COVID are availble at this link
RECOMMENDATIONS FOR EPIDEMIC DISEASE OCCURRENCE›Monkeypox Virus (MPXV)
ECDC assessment for SoHO in the context of the 2024 MPXV clade I outbreak.
| Attachment | Size |
|---|---|
| Monkeypox Preventive Measures_OTC_June 2022 | 444.98 KB |
| Monkeypox Preventive Measures_FMT_ August 2022 | 549.33 KB |
| Attachment | Size |
|---|---|
| Monkeypox and MPHO safety. The Notify MPHO safety group - position statement | 191.97 KB |