Background Documents

VIGILANCE AND SURVEILLANCE REPORTS

Agence de la Biomedicine (ABM)

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.

Agence Nationale de Sécurité du Médicament e des Produits de Santté (ANSM)

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.

American Association of Blood Banks (AABB)

The AABB aims to advance the practice and standards of transfusion medicine and cellular therapies to optimize patient and donor care and safety. 

European Union Annual Vigilance Reports

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.

European Union Standards and Training for the Inspection of Tissue Establishments Project (EUSTITE)

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.

Food and Drug Administration (FDA)

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.

Hemovigilance and Biovigilance reports in Catalunya

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.
 

Human Fertilisation and Embryology Authority (HFEA)

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. 

Serious Hazards of Transfusion (SHOT)

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.

Transfusion and Transplantation Reactions in Patients (TRIP)

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.

United Network for Organ Sharing (UNOS)

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.

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PDF icon UNOS DTAC rpt.pdf989.45 KB

World Marrow Donors Association (WMDA)

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.

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PDF icon WMDA SEAR-Annual Report 2011.pdf67.35 KB

VIGILANCE GUIDANCE DOCUMENTS

Council of Europe – European directorate for the quality of Medicine and HealthCare (EDQM)

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:

Guide to the quality and safety of organs for transplantation, 6th edition

Guide to the quality and safety of tissues and cells for human application

Blood Transfusion Guide

Declaration (The) of Istanbul on Organ trafficking and transplant tourism

The Declaration clarifies the issues of transplant tourism, trafficking and commercialism and provides ethical guidelines for practice in organ donation and transplantation

http://www.declarationofistanbul.org/

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European Centre for Disease Prevention and Control (ECDC)

European Framework for the Evaluation of Organ Transplants (EFRETOS)

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.

International Haemovigilance Network (IHN)

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.

International Society of Blood Transfusion (ISBT)

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.

US Department of Health and Human Services

Vigilance and Surveillance of Substances of Human Origin Project (SOHOV&S)

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.

WORLD HEALTH ORGANISATION (WHO) AND WORLD HEALTH ASSEMBLY (WHA)

WORLD HEALTH ASSEMBLY (WHA)

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PDF icon WHA Resolution 63.22.2010.pdf14.4 KB

RECOMMENDATIONS FOR EPIDEMIC DISEASE OCCURRENCEZIKA VIRUS DISEASE EPIDEMIC

Advancing Transfunsion and Cellular Therapies Worldwilde (AABB)

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PDF icon AABB News - 04-03-2016.pdf428.48 KB

Agencia Nacional de Vigilancia Sanitaria (ANVISA)

Centers for Disease Control and Prevention (CDC)

The CDC is one of the major operating components of the Department of Health and Human Services in America

European Centre for Disease Prevention and Control (ECDC)

European Commission (Directorate General for Health and Food Safety)

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

Food and Drug Administration (FDA)

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PDF icon FDA.pdf75.93 KB

National Health Service Blood and Transplant (NHSBT)

Organ Procurement and Transplantation Network (OPTN)

Organizacion Nacional de Trasplantes (ONT)

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PDF icon ONT - RECOMENDACIONES VIRUS ZIKA.pdf154.4 KB

Transplant Infectious Disease (TID)

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PDF icon TID - TTS.pdf1.53 MB