Avoiding Catastrophic Risk in Temperature Controlled Storage

The case for an automated wireless temperature monitoring system in non-regulated medicine


Introduction


It might be tempting to think that temperature monitoring systems for non-regulated medical sectors don’t need to be as comprehensive as those that are regulated by the FDA. 

However, a number of high profile failures have been attributed to performance issues in installed monitoring systems and have had devastating consequences for patients.   A monitoring failure has potentially disastrous financial consequences.  Not to mention the loss of reputation and credibility in an industry where those are paramount.


Preventable Loss

In this recent article, we learn how three cancer survivors are suing a Cleveland-area fertility clinic that accidentally destroyed more than 4,000 stored embryos and eggs due to a monitoring failure.


All three women allege they risked their lives by delaying chemotherapy to undergo painful fertility treatments. It is the latest in a series of lawsuits against clinics like the one in the Cleveland area.


The lawsuit alleges that the facility failed to ensure that its local and remote monitoring systems were functional despite being aware of issues with a liquid nitrogen storage tank.

In this case, not isolated by any means, the concern was that priceless samples were not being stored properly.


The only way of guaranteeing proper storage is to implement a system where monitoring of the samples is automated and that appropriate alarms are in place to alert stakeholders before a catastrophic failure.

The case for an automated wireless temperature monitoring system

When storing vital samples, like eggs and embryos, it is imperative that the highest level of care is taken to ensure the viability of every sample.  An integrated procedure of temperature monitoring along with detailed record-keeping is the foundation of the compliance strategy for all medical facilities where products or samples need to be kept within specific temperature limits.


Manually monitoring and recording the temperatures is time-consuming and a poor use of highly skilled staff. It is also subject to human-error.  In FDA regulated industries, like plasma centers, non-compliance is not an option.  It shouldn’t be in those industries that aren’t regulated either.  The risk of improper storage is something that no industry can afford to take lightly.


Mitigating Risk

So, how do you mitigate the risk? There is so much reliance on safe storage and traceability, that just a simple mistake such as a fridge door accidentally left ajar can damage priceless inventory.  Human-error can render vital and valuable products useless as was the case at the fertility clinic.  For this very reason, it is crucial to implement a  temperature monitoring process with a provider that you can trust.


An automated wireless temperature monitoring system, such as the Genesis 3 System from Tutela, delivers unparalleled accuracy, totally rock-solid audit trails and regulatory compliance that will protect your valuable assets.  The Genesis 3 System gives you the confidence that you will pass every audit that comes your way.


The Value of Monitoring with Alarming

With a Tutela wireless temperature monitoring system in place, integrated with a live call center, temperature values are transmitted constantly from temperature sensors to your own web-interface as well as to secure Tutela servers.


Any deviation outside of pre-agreed parameters will be detected and reported immediately allowing you to take action, preventing the loss of valuable inventory.

What Should You Do?

Make sure to choose a system that is fully validated with records that are FDA 21 CFR part 11 compliant.  Make sure that all records are securely stored in multiple geographical locations for up to 40 years.


The temperature monitoring system that you select should fulfill the requirements of the FDA code, which includes the use of unique electronic signatures specifically linked to operator names.  This gives you the peace of mind that your temperature data is fully traceable.

With the Tutela System, all sensors and transducers are fully NIST/UKAS traceable and calibrated as part of the installation process.  All compliance audit and validation documentation is published in electronic format on the customer’s private interface library.

All secure customer interface user activity is logged for subsequent qualification and audit purposes.


Preventing Loss and Saving Cost

An integrated wireless temperature monitoring system, like the Genesis 3, has so much to offer a clinical facility with refrigerated assets to protect. 


  • It provides a far greater degree of protection for valuable samples – not only  financially but also ensures maximum viability. 

  • You can redeploy valuable and often highly qualified staff.  This frees up staff resources and allows them to perform other critical tasks.


By using a web-based system, data is securely accessible 24/7 anywhere in the world on any device able to support a web-browser.   This means that you can count on unbeatable data access at your fingertips.  You can also rest assured that you have complete compliance through rigorous data security, traceability and audit trails.

Tutela works with many fertility clinics to ensure that their eggs and embryos are safely stored.  Isn’t it worth your peace of mind to know that your samples are protected, too?


Contact Tutela for more information about our temperature monitoring systems

485 Mariner Blvd., Spring Hill, FL  34609 | 941-462-1067

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