Over the past several years, life science industries have seen a steady increase in regulatory oversight. However, the IVF/ART industry is one sector where major regulations have not been implemented at a nationwide level.
THE ROLE OF IVF REGULATIONS
Unfortunately, incidents resulting in major losses of eggs and embryos have impacted the industry’s image and have led to increased calls for higher governmental regulation. In one recent incident, almost 1,000 families were affected after a cryotank malfunction, and thousands of samples were damaged.
Many of the samples dated back several years and represented a majority of these families’ last chance to have a biological child. According to press reports, the staff was aware that the dewar had not been working properly for weeks but they failed to move the samples to better functioning dewars. After the remote alarm system was turned off, none of the clinical staff were alerted to the temperature fluctuation over the weekend. This led to the loss of almost every sample stored in the faulty dewar. Even though the families affected signed consent forms detailing the risks involved in the freezing and storage of specimens, this particular organization is now subject to ongoing litigation.
Lack of Regulations
While discussing the loss at this fertility clinic, Dov Fox, director of the Center for Health, Law Policy, and Bioethics at the University of San Diego, said “There is almost no regulation or oversight of any kind that relates directly to the prevention of mistakes like these. And it's not just fertility clinics, it's sperm banks, egg vendors, surrogacy agencies, in all these areas, we don't know how common the mistakes are, because there is no reporting, no tracking agencies.”
According to data from the Society for Assisted Reproductive Technology, in 2009 475 US patients decided to freeze their eggs in hopes of one day starting a family through in vitro fertilization. By 2015, that number of patients jumped to 7,518. In total, over 20,000 women in the US have frozen their eggs during these six years.
As the demand for IVF/ART continues to rise, major losses can hurt a clinic's reputation and deter future patients from seeking their services. Fertility clinics looking to become respected leaders in the IVF/ART industry will need to prove to potential patients that their precious samples will be taken care of until they’re needed. The ability to prove a high level of security by safeguarding eggs and embryos is a competitive advantage for clinics attracting new customers.
Fertility clinics, according to guidelines established by federal oversight agencies, can report little to no data on their operations, with little to no consequences from regulatory bodies. Julie Cantor, a lecturer at UCLA School of Law, described the current status quo as, "A savvy patient might avoid non-reporting clinics -- it's a loose proxy that the clinic may not play by other rules and guidelines -- and it could be a good marketing point for clinics that do report, but there's no daunting penalty."
With increased calls for government regulation and more informed patients asking the right questions, the industry will undoubtedly benefit from raising the bar when it comes to better safeguards and protocols in the storage and handling of sensitive patient samples. Independent real-time monitoring systems need to be put in place to immediately detect deviations and failures.
Escalation protocols should be built in so that malfunctioning equipment gets the necessary attention when needed and any samples can be properly relocated before a failure happens. Alerts and responses need to be tracked to ensure and document that SOPs are being properly followed. Executives and Directors should have quick access to dashboards that alert them in real-time to any problems that can adversely affect their organizations' assets and reputation. Most importantly, managers need to know that the right responsive protocols are being followed and documented.
Secure monitoring systems for IVF/ART organizations that aim to be at the forefront of the industry are software-based, cloud platforms that collect data from equipment and facilities in real-time and deliver it via user-friendly dashboards in a way that is relevant to specific roles in the organization. These solutions should offer third-party monitoring services, similar to an ADT home monitoring system, so when an alarm is triggered and a response is needed, a representative oversees the process to make sure all relevant personnel are aware of the incident and the appropriate SOPs are adhered to.
With high-quality data outputs from all devices, predictive analytics will indicate problems before they happen, prevent loss, optimize equipment maintenance schedules, and keep a watchful eye on all facilities. Systems such as XiltriX will set you apart as an organization, protect your reputation and your science, and most importantly, will help you sleep at night.
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