Last month was a wake-up call for cryogenic tank failures in fertility clinics in the US. Two separate medical centers storing reproductive tissues had failures in their Liquid Nitrogen tank monitoring. In one clinic, their initial estimate of 2,000 total affected eggs and embryos later doubled to over 4,000. Not only is this a devastating loss for clients, but the facilities must endure a very public catastrophe. In both cases, there was a remote alarm system on the storage tanks. In at least one case, the remote alarm may have been turned off.(At the bottom of this article relevant regulations and related reading.)
Although the root causes may be slightly different in each clinic, the solution for both would have been same:
• A remote alarm that sends alert to personnel regardless of time of day
• Periodic alarm testing
• Software that has user permissions to limit alarm configuration
• Interface features that will not allow users to inadvertently disarm the system.
Both clinics are still investigating the incidents. But in a letter published by one fertility clinic it is clear that an alarm should have been sent and received. The letter states: "We don’t know who turned off the remote alarm nor do we know how long it was off, but it appears to have been off for a period of time." In one of the tank monitoring failures, the facility knew the tank was in need of preventative maintenance and was working with the manufacturer to troubleshoot the issue. Unfortunately, two problems arising at once is exactly why systems need to have safeguarding mechanisms that ensure no one can accidentally disable the alarm.
In viewLinc, all events are recorded within a secure audit trail and displayed on the Events page where users can filter by monitored locations, user names, alarms, data transfers, and user notes. Any alarm within the system will be shown and information will include alarm status, duration, and any acknowledgments and comments that have been made. Alarm conditions displayed include high, low, open circuit, and communications loss. Each sensor can have up to eight different high or low conditions, ensuring that designated personnel are notified based on alarm severity or a standard escalation tree. Features like this are ideal for situations where you know that a chamber or LN2 tank may be having functional issues. Most viewLinc users set up their software's escalation and thresholds to match the needs of their application. The viewLinc software allows users to pause alarms, but only under certain conditions, and they must complete a process to do so. In other words, there is no "toggling" on and off of alarms. Alarms can be paused for predefined periods, allowing the user to turn off any sensor alarms during load cycles, or maintenance periods. After the pause time has been reached, the alarms will automatically re-enable for that sensor. All actions require the user to confirm identity and input comments.
During facility off-hours, viewLinc sends alerts automatically via email, text, voice to multiple users to ensure each notification is responded to. Any alert can be configured to describe the alarm type, status, the threshold limits, and the current live value. If the alarm condition persists, the alert can repeat in user-selectable increments, indicating the current value of the sensor. For alarm acknowledgment, all users assigned to a given sensor can be notified that the alarm has been acknowledged, then notified again when the sensor value is back in the normal range. The software is designed to give a number of options for alarming.
What is not optional in viewLinc, is an alarm being disabled by anyone who can access the system. Users require the right permissions level and must go through actionable steps for final confirmation. The audit trail records every interaction. So if someone acknowledges the alarm and does not follow up, the system has recorded that. The complaint we never hear about viewLinc (and probably never will) is that an alarm didn't go off, didn't send its message to the designated personnel, or the audit trail didn't record an interaction or event. The software was designed with people and processes in mind; specifically busy human beings storing precious, invaluable materials where “failure is not an option.”
For more information on viewLinc monitoring of Liquid Nitrogen (LN2) temperature monitoring, read our Application Note:
Reproductive tissue is regulated under section 361 of the Public Health Service (PHS Act). See: Guidance for Industry: Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) - Small Entity Compliance Guide
Also: CFR Title 21 PART 1271 -Human Cells, Tissues, and Cellular and Tissue-based products (Subparts C and D)
"European Society of Human Reproduction and Embryology (ESHRE) guidelines for good practice in IVF laboratories"
Key learning objectives:
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