Texas Fertility Center was so sorry to hear about the tragic events at University Hospitals Fertility Center in Cleveland and Pacific Fertility Center in San Francisco
Despite the fact that all IVF laboratories have some level of systems in place for IVF storage safety, a major malfunction apparently occurred that potentially affected thousands of frozen embryos and eggs. These are obviously tragic events. We want to convey our heartfelt sympathy to the patients, as well as the physicians and staff at both fertility centers.
We all understand the responsibility of safeguarding our patients’ genetic material, and an event like this is devastating to everyone involved. Although the specific events surrounding these tragedies are still unknown, there are several things that we do know. We all know that physicians and IVF laboratory personnel have developed systems that both anticipate and prevent a tragedy such as this. As a result, despite performing over 150,000 IVF cycles in over 500 IVF laboratories in the US every year, events such as these are extremely rare.
There are many reasons for this, including fact that physicians and IVF laboratory personnel from around the world work together to share best practices for laboratory safety and security. We also work closely with industry to design better storage tanks and early detection systems that can immediately alert us to any potential problem. Each of our laboratories is certified and licensed by federal and state agencies that regularly review our policies and procedures. As part of this process, IVF laboratories undergo regular and surprise inspections by CAP, CLIA, and the FDA.
Exploring IVF storage safety
Regardless, events like these understandably cause concern for our patients about IVF storage safety. For this reason, we would like to take the time to describe the specific safeguards that we have in place to prevent – as much as humanly possible – anything like this from happening at TFC.
First of all, it is important to understand how frozen embryos are stored. Rather than storing them in freezers that require electricity, frozen embryos are in large insulated tanks. These tanks have an outer layer of stainless steel that surrounds many layers of thick insulation. This insulation is necessary, as liquid nitrogen has a temperature of -321O Fahrenheit. At this temperature, cellular metabolism ceases. This explains why embryos, eggs and sperm can be successfully frozen for many years and can still function normally after they are thawed.
We clearly label and individually store each sperm, egg, or embryo specimen. We store them in thick walled cryo devices that can withstand these extreme temperatures. They are then placed into the bottom of each large cryotank, submerged in the liquid nitrogen. One of the major characteristics of liquid nitrogen is that if it’s temperature rises, it starts to boil – leading to evaporation of the liquid. For this reason, we closely monitor the temperature of each cryotank using state of the art temperature sensors. These sensors wirelessly transmit information to monitors located in the laboratory as well as to an alarm system.
Additional safety measures
The liquid nitrogen in a cryotank actually exists in two forms – liquid and vapor. The liquid layer is at the bottom of the tank, while the vapor is at the top. Even at its normal temperature, liquid nitrogen slowly evaporates. Therefore, our laboratory personnel perform daily inspections to monitor the level of the actual liquid form of nitrogen. Storage tanks come in various sizes, but our large tanks typically contain around 40 inches of liquid. Therefore, every day, our personnel confirm that the liquid level is appropriate, adding additional nitrogen as necessary, to keep all specimens in the more stable liquid phase.
As the temperature sensors enter the liquid and not the vapor phase, the slightest change in temperature will alert our staff of any variance. The normal level of evaporation is so slow that, even if we did not add any liquid nitrogen on a regular basis, it would take several weeks for the level to fall below the level where specimens are stored.
Due to the multiple layers of regular insulation and vacuum insulation, a catastrophic leak is very unlikely. Regardless, in the unlikely event of a leak, the sensors can detect the slightest rise in temperature. They then send a signal to the monitors, which generate an audible alarm heard throughout the laboratory. The alarm system also calls our laboratory director immediately. It also sends text and email messages, so he can respond and deal with any problem.
Ovation storage and safety
While we do store genetic material onsite for TFC patients who are currently undergoing an IUI, IVF, or FET cycle, we encourage all other patients to allow us to send their specimens to Ovation Fertility’s long-term storage site. Ovation has built a secured site specifically for long term storage, equipped with state of the art onsite and 24-hour video monitoring. The site has experienced personnel who ensure the safety and security of your genetic material.
Again, while we are all awaiting more information from Cleveland and San Francisco, we want you to be able to rest assured that we have rigorous policies and procedures in place to guard against any such eventuality occurring here. Having said that, we can assure you that we will thoroughly review information from Cleveland and San Francisco to ensure that we can improve our procedures if necessary. We remain confident that the safeguards that exist, both at TFC and Ovation, will minimize any risk to your genetic material. We encourage you to contact us if you have any additional questions about IVF storage safety.