About Freezing Embryos and Sperm
Embryo and Sperm Monitoring
Employees should monitor the computer that controls the freezing system. The system also needs a dedicated alarm system. The embryologists are responsible for maintaining the bank and no other employee has access. Standard practice indicates a daily physical inspection. During this inspection, an employee also assesses the nitrogen levels.
Electronic tank monitoring uses different sensors to ensure that tanks perform to specifications. Many facilities use probes attached to the tank detect a rise in temperature within the tank or a drop in the level of liquid in the tank. Sensors are connected to a telephone alarm system that will alert staff to an alarm condition outside of normal working hours. An employee should test the alarm weekly and ensure the tank will operate on battery power.
Fertility Freezer Malfunction
Also, a few weeks before the Pacific Fertility Clinic’s tank malfunctioned, the University Hospitals Fertility Center in Cleveland lost 4,000 eggs and embryos to a fertility freezer malfunction as well. The clinic originally only estimated the loss to be at 1,000, however over 1,000 patients received letters concerning the event. The company blames user error saying that the remote alarm system on the tank, which should have alerted an employee to temperature swings, was shut off. The center does not know who turned it off.
History of Malfunctions
An NBC News investigation found Custom Biogenic Systems, the manufacturer of the failing storage tank, has a history of previous malfunctions. These data back almost 15 years. In fact, in 2003, British regulators warned not to use these freezers. Regulators rescinded the alert after the company insisted it upgraded all the questionable tanks. However, two years after the warning, a similar incident occurred in Gainesville, Florida. Up to 60 male patients, many with cancer, lost stored sperm when a tank made by the same manufacturer failed.
Few Regulations
Experts in the fields point to a problem of a “regulatory vacuum”. There is no reliable data on procedures and clinics in the United States. This could mean possible problems with frozen eggs and embryos and creates oversight. Multiple government agencies insist they do not have any control over this industry. The only agency able to possibly regulate storage tanks is the FDA. However, these tanks are not specifically marketed as medical devices, so the agency does not regulate them. Without regulations, a fertility freezer malfunction will continue to affect thousands across the United States.
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