Background Documents

Agencia Nacional de Vigilancia Sanitaria (ANVISA)

Committee DGS / ISPT, I.P./ INSA, I.P (Portugal)

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 Santé (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. (to see all SHOT Report)

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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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.

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, 7th 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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PDF icon 2018 Declaration of Istanbul.pdf213.99 KB

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.

Global Alliance of Eye Bank Associations

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.

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 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.

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 (ZIKAV)

Agencia Nacional de Vigilancia Sanitaria (ANVISA)

American Association of Blood Banks (AABB)

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

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)

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

RECOMMENDATIONS FOR EPIDEMIC DISEASE OCCURRENCESARS-CoV-2

American Association of Blood Banks (AABB)

AABB Coronavirus resources are available at the link

Further information on Convalescent Plasma can be found on Covidplasma.org

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PDF icon COVID-19 Convalescent Plasma Resources185.34 KB

American Society for Reproductive Medicine (ASRM)

American Society for Transplantation (AST)

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)

 

Committee SADI-SAT-INCUCAI

Dutch Transplant Foundation

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PDF icon Donor selection Guideline357.31 KB

European Commission - Directorate General for Health and Food Safety (EC - DG SANTE)

European Society for Blood and Marrow Transplantation (EBMT)

EBMT webinars on COVID 19 are available at this link

European Society of Human Reproduction and Embryology (ESHRE)

updates on ESHRE news and statements

webinar on COVID-19 and ART recording available at the link

Eye Bank Association of America (EBAA)

Global Alliance of Eye Bank Associations (GAEBA)

GAEBA is the Global Alliance of Eye Bank Associations, an internationnaly recognised assicaition of Eye bank association.

Health Canada

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.

International Liver Transplantation Society (ILTS)

International Society of Blood Transfusion (ISBT)

ISBT webinars on COVID-19 and blood supply are available at this link

Italian National Blood Centre (CNS)

Latest CNS guidance on SARS-CoV-2 and blood supply are availabe in italian at the link 

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PDF icon CNS recommendations on SARS-CoV-2138.89 KB

Italian Society of Embryology, Reproduction and Research (SIERR)

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

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PDF icon Coronavirus Infection.pdf56.02 KB

Swisstransplant

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.

The European Directorate for the Quality of Medicines and HealthCare (EDQM)

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.

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PDF icon Presentations4.31 MB

The International Society for Heart and Lung Transplantation (ISHLT)

Upcoming ISHLT webinar on COVID-19 and Transplantation are available at this link

Transplantation Society (TTS) and Transplant Infectious Disease Section (TID)

TTS COVID-19 dashboard is also available at the link

World Marrow Donor Association (WMDA)

Coronavirus - Impact on registry operation

New guidance on stem cell donation and COVID are availble at this link