Managing risk associated with cryopreservation.

Abstract

Patients who consent to the frozen storage of sperm or embryos quite rightly expect the storing centre to do everything reasonably possible to keep them in optimum conditions. Both the process of cryopreservation and the cryofacility are loaded with risk, from patient/sample processing, through to the eventual utilization or disposal of specimens. The risk management process should focus on minimizing losses, including staff injury, premature warming of cells and tissues, mistaken identity, and transmission of infection. Early warning and monitoring systems should be in place for quality assurance and to prevent incidents involving cryovessels turning critical. Centres must ensure that every reasonable practical measure that can be put in place is done so, and that resourcing of the service adequately reflects the liability it represents.