Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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5.2. Notification of serious adverse reactions (Recipients)

1. All adverse events and reactions that are suspected of being related to the quality and safety of tissues or cells should be notified to TEs to allow trends in minor events and reactions to be monitored for continuous improvement purposes.

2. TEs should then apply the adequate tools to assess the severity, the imputability and the impact, in collaboration with appropriate stakeholders, and to identify those serious adverse events and reactions that should be notified to Competent Authorities.

3. Clinical symptoms or situations suggesting that any of the following reactions might have occurred in a tissue or cell recipient (abbreviated descriptions in brackets) should be seen as triggers for an adverse reaction report. Note that the list is not exhaustive.

  1. Unexpected primary infections possibly transferred from the donor to recipient (e.g. viral, bacterial, parasitic, fungal, prion) (Infection - Donor);
  2. Transmitted infection (viral, bacterial, parasitic, fungal, prion) possibly due to contamination or cross-contamination by an infectious agent on the procured tissues, cells or associated materials from procurement to clinical application (Infection – Tissue/cells);
  3. Hypersensitivity reactions, including allergy, anaphylactoid reactions or anaphylaxis (Hypersensitivity);
  4. Malignant disease possibly transferred by the tissue/cells (whatever the origin, donor or process) (Malignancy);
  5. Unexpectedly delayed or absent engraftment, graft failure (including mechanical failure) (Failure);
  6. Toxic effects from tissues and cells or associated materials (Toxicity);
  7. Unexpected immunological reactions due to tissue/cell mismatch (Mismatch);
  8. Aborted procedure involving unnecessary exposure to risk e.g. wrong tissue supplied, discovered after patient is anaesthetised and the surgical procedure has begun (Undue Risk);
  9. Suspected transmission of genetic disease (Genetic Abnormality);
  10. Suspected transmission of other (non-infectious) illness (Other Transmission).
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