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Reporting Incidents and Serious Adverse Events and Reactions (SAEARs)

We would like to remind you that, despite the thorough screening the donor must undergo, being tissue biologic material of human origin, possible risks cannot be completely excluded. It is important to be aware that even if the tissue is validated and distributed, there is a margin of uncertainty intrinsic to the anamnesis and the donor. Despite serious adverse reactions to the transplanted tissue have never been registered by us, they cannot be fully excluded. 


An unexpected incident is any unforeseeable event connected to any phase of the process of donation and transplant, which can bring unintentional and undesirable damage to the donor or recipient. It is any negative event connected to the procurement, control, processing, banking and distribution of tissue, that could also lead to an Adverse Reaction.


If any urgent incident or near-miss happens that might compromise the integrity, safety and quality of the tissue and therefore the treatment for recipients or potential recipients, please report it to us by getting in touch immediately. CALL +39051 6366488 


An Adverse Reaction is an unwanted reaction that can occur also despite all the correct procedures being carried out.


A Serious Adverse Events and Reactions (SAEARs) is a strong unwanted response in the donor or recipient connected to the procurement or the transplant of tissue, that can cause:

  • The transmission of undesirable illnesses
  • Serious life-threatening conditions
  • Permanent or significant invalidity and/or disability
  • Hospitalisation or extension of hospitalisation necessary
  • Death

Examples of SAEARs (immediate or detected in the 6 to 12 follow-up months)

  • Radiographic resorption of the graft
  • Implantation failure and persistency of the defect
  • Mechanical failure, breaking of the graft
  • Infection of the graft
  • The appearance of a transmittable disease
  • Biological damage

According to the Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells (and the transposition act of the Italian legislation with the Decree n°191, November 6th, 2007) and the Commission Directive 2006/86/EC of 24 October 2006 implementing Directive 2004/23/EC of the European Parliament and of the Council as regards traceability requirements, notification of serious adverse reactions and events and certain technical requirements for the coding, processing, preservation, storage and distribution of human tissues and cells, any SAEARs, attributable to the graft or donation, must be reported to the tissue Bank of reference immediately. Each bank must be able to withdraw from distribution immediately, any product that could be connected to any SAEARs and notify immediately the Regional  Transplant Centre CRT and National Transplant Centre CNT.


What to do in case of SAEARs or URGENT INCIDENT?

 

  • Get in touch with us immediately by calling +39051 6366488
  • Fill in the form “Declaration of use” (you received it with the tissue parcel) and also attach any laboratory test result and imaging report.

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