Earlier today (17-April-2023) he Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse Reaction/Event Reporting for Human Organs Intended for Transplantation" which provides provide guidance on the procedure to follow for reporting suspected SAR/Es.
A serious adverse reaction (SAR) is defined in the legislation as ‘an unintended response, including a communicable disease, in the living donor or in the recipient that might be associated with any stage of the chain from donation to transplantation:
that is fatal, life-threatening, disabling, incapacitating, or
which results in, or prolongs, hospitalisation or morbidity
A serious adverse event (SAE) is defined in the legislation as ‘any undesired and unexpected occurrence associated with any stage of the chain from donation to transplantation:
that might lead to the transmission of a communicable disease;
that might lead to death or life-threatening, disabling or incapacitating conditions for patients; or
which results in, or prolongs, hospitalisation or morbidity.
A key purpose of this document is to provide guidance to procurement organizations / transplantation centers and/or other relevant organizations regarding the reporting procedure for suspected SAR/Es.
The SAR/E report form is explained, the reportable reactions and events are defined, and examples of SARs and Es are provided.
SAR/Es must be reported to highlight any unexpected complications, especially if recipients are at risk, as they provide an opportunity to monitor organ quality and safety from donation to transplantation through investigation and implementation of corrective and preventative actions (CAPA).
As part of the SAR/E report form, the submitting person should assign a unique report identification number that can be used to link information back to the case. This supports the future traceability of the report.
To know more in detail about the Instructions to complete the Forms, click this LINK.
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