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.
|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.
|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|
The European Commission (Directorate General for Health and Consumer Protection) receives annual vigilance reports for different MPHO types from the Competent Authorities of its 28 Member States. It publishes collated summaries of these reports.
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.
|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|
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.
|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.
|Informe d'hemovigilància 2014 a Catalunya interactiu.pdf||5.65 MB|
|Report Hemovigilance Catalunya 2013.pdf||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.
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)
|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 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.
|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 tissuevigilance 2011||1.7 MB|
|TRIP hemovigilance 2010||864.38 KB|
|TRIP tissuevigilance 2010||164.86 KB|
|TRIP hemovigilance 2009||507.69 KB|
|TRIP tissuevigilance 2009||581.53 KB|
United Network for Organ Sharing (UNOS) is the private, non-profit organization that manages the organ transplant system in the United States of America under contract with the federal government. UNOS gathers and analyses reports of adverse outcomes associated with organ transplantation and publishes annual reports summarising the key findings.
|UNOS DTAC rpt.pdf||989.45 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.
EDQM is the Council of Europe Directorate for the Quality of Medicines & HealthCare and co-ordinates the transplantation and transfusion-related activities. Documents are available at the following links:
The Declaration clarifies the issues of transplant tourism, trafficking and commercialism and provides ethical guidelines for practice in organ donation and transplantation
|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.
|EFRETOS Recommendations on Organ Vigilance.pdf||1.14 MB|
|FDA Investigating and reporting adverse reactions - Guidance for Industry||391.96 KB|
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.
|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.
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.
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.
|WHA Resolution 63.22.2010.pdf||14.4 KB|
|NOTA+TÉCNICA+ANVISA ZIKA 16 marzo 2016.pdf||91.9 KB|
|AABB News - 04-03-2016.pdf||428.48 KB|
The CDC is one of the major operating components of the Department of Health and Human Services in America
|zika risk assessment 9 april 2019||814.92 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
|Outbreak of Zika Virus Disease - European Commission.pdf||69.73 KB|
|ONT - RECOMENDACIONES VIRUS ZIKA.pdf||154.4 KB|
|TID - TTS.pdf||1.53 MB|