Tissue vigilance

Definition and objectives

Tissue vigilance can be understood as a monitoring system that covers the entire transplant chain from donation, processing and transport to transplantation of human cells and tissues to the patient.

The aim of a tissue vigilance system is to minimise risks and hazards associated with the use, production, processing, storage or distribution of human cells or tissues.

Official Announcement

Here you will find the latest official news.

Further current publications and general information on communicable diseases can be found under the following links:

European Monitoring Authority ECDC

Federal Ministry of Labour, Social Affairs, Health and Consumer Protection

Austrian gnat monitoring programme by AGES

Notification of a suspected reaction

„Serious adverse reaction" means an unintended response, including a communicable disease, in the donor or recipient associated with the procurement or human application of cells and tissues that is fatal, life-threatening, disabling, incapacitating, or which results in, or prolongs, hospitalisation, or morbidity.

The following form is used to report a reaction:

Notification of a suspected event

A "serious adverse event" means any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients, or which might result in, or prolong, hospitalisation, or morbidity.

The following form is used for reporting an event:

Email

Further inquiry note

gewebevigilanzbasg.gvat
Allgemein Fax:: +43 (0)50 555-36408
Notfalltelefonnummer (24-Stunden):: +43 (0)664 831 28 43

Annual reports

Every tissue bank or procurement establishments must submit a complete report on all serious adverse reactions and events to the Federal Office for Safety in Health Care by 30 April at the latest for the previous calendar year.

The annual report is divided into the following sub-areas:

Annual report on activities of tissue establishments

Tissue establishments shall submit a report on their activities in the previous calendar year to the Federal Office for Safety in Health Care by 30 April.

Accompanying letter to the activity report 2017

Tissue bank and procurement establishments licence numbers

The annual activity reports of the tissue banks are subdivided into the following sections:

Notify Library

The "Notify Library" is a database containing worldwide vigilance cases of blood, tissue and cells. Case studies can thus be viewed and serve as tools for research, training and further education. This library aims to support  investigations by providing a historical overview of documented cases of adverse reactions and events with a structured analysis by international experts.

Eustite Vigilance Tools

The Eustite Vigilance Tool can be used for the classification of vigilance cases of  tissue. This tool makes it easier to determine the severity of the reaction and the probability associated with the tissue and cells product. It can also be used to classify adverse events.

What has to be reported?

The „Eustite Vigilance Tool“can be used to assist in the classification of reactions and events.

What is the reporting process of a reaction at the donor?

All suspected serious adverse reactions occurring in the donor must be reported immediately to the tissue establishment. The tissue establishment then issues a vigilance report to the Federal Office for Safety in Health Care (BASG).

In the case of direct use, it is the respective institution that shall submit the notification to the Federal Office for Safety in Health Care (BASG).

What is the reporting process of a reaction by the recipient?

Users shall immediately report any suspected serious adverse reactions to the tissue establishment. The tissue establishment then issues a vigilance report to the tissue vigilance of the BASG.

In the case of direct use, it is the respective institution that is to send the notification to the BASG.

What is the reporting procedure for an event?

Each establishment shall immediately report all suspected serious adverse events to the tissue establishment. The tissue bank or, in the case of direct use, each establishment shall then submit a vigilance report to the Federal Office for Safety in Health Care (BASG).

When must the annual report on reactions and events be submitted at the latest?

Annual reports must be sent to the Federal Office for Safety in Health Care (BASG) by 30 April at the latest for the previous calendar year.

When must the activity report be submitted at the latest?

Annual reports must be sent to the Federal Office for Safety in Health Care (BASG) by 30 April at the latest for the previous calendar year.

Reports

Summarizing report on activities of the Austrian tissue establishments

A summarizing report on activities of the Austrian tissue establishments may be consulted publicly.

Further reports

A report on the reports of serious events and serious adverse reactions shall be submitted to the relevant Federal Ministry.

Furthermore, the transplant advisory board (GÖG) to submit a report on the activities of tissue establishments.

Reporting to the European Commission

Member States are required to submit an annual summary report to the European Commission. In order to harmonise the data, all member states use the Common Approach, which is prepared by the European Commission in cooperation with the member states.

The European Commission publishes its publications on its website. This includes the annual summary report of all tissue vigilance data of the Member States.

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