Out of the Freezer and into the Policy Fire: Quandaries in Reproductive Cryopreservation

Abstract

The field of assisted reproduction is advancing rapidly and is ripe for regulation and guidance. In 2018, over four thousand frozen eggs and embryos were lost to approximately one thousand patients at Ahuja University Hospital in Cleveland, Ohio, due to an accidental thaw of a cryopreservation tank. The precedent that will be set by the Ahuja class‐action case is significant for both past events and future possibilities and is core to the discussion of policy involving the cryopreservation of gametes and embryos.

Cryopreservation as a Key Element in the Successful Delivery of Cell-Based Therapies—A Review

“…During cryostorage, care must also be taken not to warm other samples that may have to be moved to provide access to the material being located. Best practice will also employ alarms and continual temperature monitoring to prevent sample loss in the event of power failure or malfunction ( 172 , 177 , 178 ). Containers can be purchased with barcodes, or these, and other forms of identification, can be added as required.…”

Lawsuit frequency and claims basis over lost, damaged, and destroyed frozen embryos over a 10-year period

“…A detailed review of contributory factors suggests their avoidance will depend on not just reliable equipment but also effective monitoring systems for managing the storage facilities for frozen embryos (14). The U.S. Food and Drug Administration classifies these tanks as Class II devices, which are not subject to even premarket approval (15). In the absence of federal oversight, the manufacturing and use of cryopreservation tanks could be regulated at the state level to minimize the risk of embryo loss.…”