Vigilance

An adverse event is any incident or error associated with SoHO activities that can affect the quality or safety of SoHO in such a way that implies a risk of harm to a living SoHO donor, to a SoHO recipient or to offspring from medically assisted reproduction. An adverse event is serious when it poses a risk of any of the following:  

a) inappropriate SoHO distribution; 

b) a defect posing a risk to SoHO recipients or SoHO donors is detected in one SoHO entity that would have implications for other SoHO recipients or SoHO donors because of shared practices, services, supplies or critical equipment; 

c) loss of a quantity of SoHO that causes human applications to be postponed or cancelled; 

d) loss of highly matched SoHO or SoHO for autologous use; 

e) a mix-up of reproductive SoHO in such a way that an oocyte is fertilised with sperm from a person other than the intended person, or reproductive SoHO are applied to a SoHO recipient other than the intended SoHO recipient; 

f) loss of the traceability of SoHO.

An adverse reaction is an incident which could be reasonably associated with the quality or safety of SoHO, or their collection from a SoHO donor or human application to a SoHO recipient, that caused harm to a living SoHO donor, to a SoHO recipient or to offspring from medically assisted reproduction. 

An adverse reaction is serious when it results in any of the following:  

a) death; 

b) life-threatening, disabling or incapacitating condition, including transmission of a pathogen or of a toxic substance that might cause such condition; 

c) transmission of a genetic disorder that: 

i) in the case of medically assisted reproduction with third-party donation, resulted in pregnancy loss or might result in a life-threatening, disabling or incapacitating condition in the offspring from medically assisted reproduction; or 

ii) in the case of medically assisted reproduction in the context of within-relationship use, resulted in pregnancy loss or might result in a life-threatening, disabling or incapacitating condition in the offspring from medically assisted reproduction, due to a pre-implantation genetic test error; 

d) hospitalisation or prolongation of hospitalisation; 

e) the need for a major clinical intervention to prevent or reduce the effects of any of the results referred to in points (a) to (d); 

f) prolonged sub-optimal health of a SoHO donor following single or multiple SoHO donations.