Some healthcare facilities have implemented extra precautions for embryo storage after a freezer system failure caused the loss of 4,000 eggs and embryos at a University Hospitals clinic in Cleveland last year. However, the situation did not empower federal agencies to implement greater oversight on fertility centers' equipment and processes, according to an investigative report from NBC News.
Four things to know:
1. More than 4,000 eggs and embryos were destroyed in March 2018 after human error caused the temperature in University Hospitals' storage tanks to increase. The health system admitted clinic staff did not receive an alert about the storage tanks' rising temperatures, which should have been flagged by CAS Data Loggers.
2. NBC News found Custom Biogenic Systems tanks, which were used at University Hospitals' clinic, demonstrated similar malfunctions in the U.K. in 2003 and at University of Florida's Women's Health Center in Gainesville in 2005. Custom Biogenic Systems told NBC News the U.K. malfunction involved a tank design that was discontinued in 2003 and said the Florida malfunction was caused by human error.
3. NBC News also noted no single federal agency is tasked with regulating the storage tanks used at fertility centers.
"Some agencies and organizations monitor the industry and collect data on it," NBC News said. "But the freezing tanks or other devices used for the long-term storage of reproductive materials are not subject to consistent oversight or regulation, and no government agency has stepped in to impose new requirements despite last year's failures."
4. The FDA only regulates cryostorage tanks "when these devices are specifically labeled for use in assisted reproduction technology procedures," the agency told NBC News. Therefore, any embryo storage tanks hospitals use that aren't specifically labeled or marketed as medical devices by manufacturers do not fall under FDA oversight.
To view the full report, click here.