Tuesday, September 19, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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A.8.1. SERIOUS ADVERSE EVENTS/REACTIONS

1. Any adverse event occurring during procurement that has or may have resulted in harm to a living donor and the outcome of any investigation to determine the cause must be recorded and reviewed.[1]

2. Member States shall ensure that there is a system in place to report, investigate, register and transmit information about serious adverse events and reactions which may influence the quality and safety of tissues and cells and which may be attributed to the procurement, testing, processing, storage and distribution of tissues and cells, as well as any serious adverse reaction observed during or after clinical application which may be linked to the quality and safety of tissues and cells.

3. All persons or establishments using human tissues and cells regulated by this Directive shall report any relevant information to establishments engaged in the donation, procurement, testing, processing, storage and distribution of human tissues and cells in order to facilitate traceability and ensure quality and safety control.

4. The responsible shall ensure that the competent authority or authorities is or are notified of any serious adverse events and reactions and is or are provided with a report analysing the cause and the ensuing outcome.

5. The procedure for notifying serious adverse events and reactions shall be established by the Commission.

6. Each TE shall ensure that an accurate, rapid and verifiable procedure is in place which will enable it to recall from distribution any product which may be related to an adverse event or reaction.[2]

7. In cases of disease transmission or infection through the implanted tissues and cells, necessary measures should be taken, including:

a)     Immediate notification of severe reactions to the competent authority;

                        i.     Inherent measures according to traceability requirements (information related to implantation centres and recovery centres);

                       ii.     Recall of the tissues and cells which have already been distributed but not used;

                     iii.     Stopping the distribution of all tissues and cells involved and recall those remaining in stock (both in the TE or in a third party facilities).

b)    Immediate measures for tissue isolation;

                        i.     Evaluation of predictable actions during the process and implementation of corrective measures and / or preventing actions when appropriate;

                       ii.     Report of the measures taken provided to the competent authority.



[1] Commission Directive 2006/17/EC ( Annex IV)

[2] Directive 2004/23/EC of the European Parliament and of the Council (Art 11)

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