BIOVIGILANCE

Biovigilance consists a total of organized surveillance procedures concerning adverse or unforeseen events or reactions that might relate with the donorship, supply monitoring, processing, storage, distribution, tissues and cells and ART offsprings as well as epidemiological surveillance of donors and receivers.

Biovigilance inludes the following two categories:

  1. Serious adverse Reaction, (SAR)

According to Directives 2004/23/EC and 2006/86/EC concerning cells and tissues, “a serious adverse reaction” is defined as an unwilling reaction including contagious disease to the donor or receiver that is connected to the receiving or application of human tissues and cells,- a disease that is lethal or life threatening causing handicapcy or disability or even results in extention of treatment or morbidity.

Also it was suggested to make an extention of the term Serious Adverse Reaction and event to the donors and to add the term transmission of infectious disease while defining SAR taking into consideration its high importance in the quality and safety of the material.

The term SAR should include the cases of transmission of genetic diseases to the offsprings with gametes donorship by third donor.

It should also include adverse reaction connecting with clinical application to embryos, eggs, sperm and also surgical and anesthesiological complications.

Data collection concerning events of moderate and serious degree of ovarian hyperstimulation syndrome is taking place at a voluntary basis up to the moment.

  1. Serious Adverse Events(SAE)

According to the Directives 2002/98/EC and 2004/23/EC) and relating to tissues and cells, as a serious adverse event is considered every “event relating to supply, monitoring processing, storage as well as tissue and cell distribution that might lead either to the transmission of contagious disease to death or life threatening handicapcy or limited ability or resulting to extention of hospitalization or morbidity for donors and receivers.

The SAE definition should include loss of stem cells, gαmetes or embryos per cycle, defective cells and tissues human error, equipment damage, all kinds of failure in every stage of the procedure.

 

 

 

Hellenic Authority of Medically Assisted Reproduction.