Meeting Global Compliance for IVDs with Reliable Temperature Monitoring

Regulatory compliance agencies around the globe began issuing temperature compliance regulations several years ago for the shipping and storage of in-vitro diagnostic devices (IVDs), a medical tool that helps to diagnose diseases such as COVID-19. These regulations, which are similar to those that govern the shipping and storage of pharmaceuticals, are aimed at protecting the temperature-sensitive reagents in the IVDs.

As a result of the regulations, many IVD manufacturers had to change many of their operational and logistics processes in order to achieve and prove compliance. For one of Sensitech’s customers, the changes necessary to meet compliance were major, and included an expansion of its relationship with Sensitech.

The Ever-Increasing Pressure of Compliance

This international medical technology organization is a manufacturer and distributor of clinical imaging, diagnostics, advanced therapies and related services. One of its product lines within the company’s laboratory diagnostics is blood-testing instruments, reagents and consumables, which includes COVID-19 test kits.

The challenge of meeting regulatory compliance for its IVD devices has been a complicated one, as globally, the regulations vary, with some countries adopting and enforcing more stringent requirements than others. And, not only do IVD regulations fluctuate from country to country, but also from product to product.

Like other manufacturers who began to comply with these diverse global regulations, this company had to update product packaging, develop stricter standard operating procedures, and execute more stringent oversight on service level agreements with third-party shippers.

As an example, one commonly required regulation that is enforced globally is strict temperature control and management, which required several actions on the part of this manufacturer. First, their products must all have label claims that show the temperature at which products must be stored and shipped, which is typically 2-8° Celsius for IVDs. Second, the manufacturer was now responsible for ensuring that its products are shipped and stored within this range, from the moment the goods leave the manufacturing plant, until they reach final destinations.

There were other required changes as well. For instance, the National Medical Products Administration (NMPA) in China began requiring proof of temperature compliance for IVDs coming into the country; consequently, procedures for documenting compliance were put in place. Similar requirements for more regulated temperature monitoring and documentation were occurring in the European Union, as well as Saudi Arabia and the United States too.

The Consequences: Costly Product Dispositions—and More

“We have a substantial volume of temperature-sensitive products in our portfolio,” says the company’s director of transportation. “All of a sudden, we needed to demonstrate with verified data that we did everything possible to keep within the prescribed limits and the product was not harmed.” The director added, “If we didn’t have the data to prove that we performed within the guidelines, we would have to dispose of products, which is, of course, something we don’t want to do.”

The ramifications of any kind of temperature excursion are costly for this company, not only financially, but in other ways as well. “If we had to dispose of products, it’s one thing as far as costs,” says the director, “but the bigger impact is that we would not be able to supply our customers with what they need when they need it.”

Many of the company’s products have a short shelf life, so it manufactures on demand and maintains low inventory levels. If a large order is compromised, it can be challenging to have sufficient available product to expedite a replacement order. “The impact on sales is much larger than a product loss,” adds the director. “It affects our reputation, which opens the door for a competitor to step in.”

A Reliable, Compliant and Data-Driven Monitoring Program

Before the increased regulatory pressure, this manufacturer used a limited number of electronic monitoring devices that reported time and temperature at the final destination.

With the increased regulatory pressure, the company did a thorough review of competitive temperature monitoring devices in the market, which included Sensitech’s real-time dataloggers that communicate via cellular connectivity. These devices could provide the manufacturer with in-the-moment information it needed to meet compliance so it expanded its existing monitoring program to include real-time. Additionally, Sensitech was able to provide valuable insights that helped the manufacturer understand the complex evolving regulations, including the requirements as they varied from country to country, which is priceless to the company.

“We have two distribution centers—one in North America and one in Europe—and we ship globally,” says the director. “Sensitech helped us understand the overall compliance requirements and what was needed to assure temperature accuracy, number of specimen points, the collection of temperature data and its management, along with which devices were a best fit. Regulatory compliance was new to us. It was a learning journey and Sensitech helped us each step of the way.”

Recently, the company also started using ColdStream^® Select, an end-to-end cloud solution for validated data. “For shipments to China, we added dataloggers inside the cartons, as well as outside on the pallets so we could measure ambient temperatures,” says the transportation director. “Monitoring the cargo in this way generates a lot of data, so using ColdStream Select helps us understand how to properly and effectively interpret the data. The fact that the data is in real time allows us to make decisions faster and resolve issues quickly.”

Compliance, Improved Efficacy—and Surprising Discoveries

This company has now been using Sensitech devices for over five years to not only achieve compliance, but also to improve the quality of its operations and logistics. Sensitech helps the company meet global compliance regulations, identify excursions and service level agreement (SLA) shortcomings, and manage lanes more effectively.

As an example of the effectiveness of the program, when the company started using real-time dataloggers for shipments to China, it experienced several unexpected temperature excursions. “We had to dive in and find where the excursion was occurring,” says the director, “and what we found surprised us.” The company discovered that most excursions actually happened in the first leg of the journey between its distribution center in Europe and the local airport. The manufacturer had an SLA for its cargo to travel and be stored in temperature-controlled environments on this leg, but uncovered its freight forwarder violated those terms. The third-party company improperly used environments that were not temperature controlled. “This was a systemic, reoccurring issue which we quickly corrected, thanks to the temperature and location data provided by the Sensitech devices,” notes the director.

Compliance-Driven Devices, Expertise—and Quality Service

As for the manufacturer’s relationship with Sensitech, the director says he is pleased, and feels that Sensitech is top notch in the industry. “The organization provides fantastic service and support, no matter what our needs. It’s a big company with a lot of resources as compared to others in the market that either don’t have the maturity or the background. We rely on that experience, service and support to help us deliver complaint products to our customers.”

“We can now implement a temperature-monitoring program in any country that requires it,” says the director, “and be confident that we are compliant.”

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