Friday, July 21, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
Vigilance Minimize

28  In the EU, who is responsible for reporting Serious Adverse Reactions or events?

 

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The tissue banks

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The transplant co-ordination centres

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Procurement organisations, tissue banks and transplant hospitals

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All the organisations involved from the selection of the donor to the follow up of the recipient

 

29. A serious adverse reactions is evaluated taking into account:

 

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The severity, the imputability and the potential impact

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The consequences for the recipient

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The severity, the imputability and the chance of recurrence

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All the above

 

 

30. Tissue Establishments

 

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Must have a system in place for the notification of serious adverse events and reactions and must communicate them to their hospital or other parent organisation

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Can decide how to manage any serious adverse event or reaction within the bank and are not obliged to communicate it to any other organisation. 

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Must have a system in place for the notification of serious adverse events and reactions and are responsible for reporting them to the Competent Authority. 

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Are not responsible for the notification of serious adverse events or reactions that occur in the facilities of third parties with whom they collaborate.

 

 

31. During transport of a heart valve from the bank to the user hospital in a distant city for immediate use, the package is stolen from the courier.  Is this a serious adverse event that should be reported to the competent authority?

 

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Yes

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No if the surgeon can use an synthetic valve

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No, because there is no risk of adverse reaction in the recipient

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It should be reported to the police but not to the Competent Authority for tissues and cells.

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