Abstract
Recent serious untoward incidents in the field of assisted reproduction have once
again highlighted the need for vigilance and in particular improved risk management
in relation to the cryopreservation of gametes and embryos. Despite increasing levels
of regulation and the requirement to adhere to total quality management practices,
catastrophic incidents such as the death of an employee or the loss of a freezer full
of patient embryos or sperm continue to occur sufficiently frequently for the industry
to be concerned and highlight the need to make practices considerably safer. Potential
losses through litigation could be considerable if the gamete or embryo bank is found
to be negligent and fails to provide the necessary resources and implement recognizable
control measures, which may include suitable facilities with adequate ventilation
and oxygen monitoring, competent staff, and an appropriate level of well-maintained
equipment; round-the-clock emergency procedures, early warning systems to deal with
a failing vessel; and contingency to mitigate losses within a failing vessel and validated
procedures which are embedded into the organization which lead to a high-quality end
product, for example, frozen embryo while permitting a safe system of work. Since
cross-contamination incidents have occurred in other disciplines such as blood cryostorage,
which have led to the transmission of viral disease, the biological safety of the
end product also requires careful consideration despite the fact that no similar incident
appears to have come to light in the field of reproductive medicine. Implementation
of risk reduction measures may include screening for blood borne viruses and possibly
bacterial infection, careful selection of appropriate packaging plastics, and consideration
as to whether packaging is suitable for immersion in liquid nitrogen. If not, vapor
phase storage may be considered as additional mitigation. In the light of recent events,
centers should place risk management of their cryofacilities and service high on the
agenda and ensure that it becomes integral to future objective setting and business
planning.
Keywords
sperm - gamete - embryo - cryopreservation - risk
