Download the full EventWatch Spotlight Report here
Sterigenics and Sterilization Challenges Ripple Across the Industry
For six months before the FDA announced the full scope of impacts arising from environmental concerns over ethylene oxide, Resilinc customers were kept up-to-date with EventWatch alerts.
What started in September 2018 as a controversy in a small Illinois town over the health impacts of ethylene oxide—a chemical gas used for sterilization in many industries—has since mushroomed into a critical supply-chain challenge affecting almost 600 medical products made by some 100 companies. At this time, the situation is still highly fluid with the potential to worsen significantly.
Many of the manufacturers whose supply chains are affected—as well as the healthcare providers who rely on these companies for products ranging from cardiac catheters to sutures, arthroscopes to biopsy kits—had no warning about the potential disruptions until February 2019, when the Illinois EPA ordered Sterigenics to suspend the use of ethylene oxide (EtO) at its Willowbrook, Ill. facility. And even then, many healthcare providers didn’t learn about the threat to their supply chains until March 26, 2019, when FDA Commissioner Scott Gottlieb outlined the scope of the problem and the agency’s evolving plans to manage it.
But not all healthcare companies were in the dark as events began to unfold last fall. On September 12, 2018, 21 medical product manufacturers that relied on Sterigenics Willowbrook facility to sterilize products or parts received an Environmental Hazard alert from Resilinc’s EventWatch system.
The alert notified them that the plant faced health and environmental issues: One man had filed a lawsuit against Sterigenics, a division of Sotera Health, claiming EtO emissions from the facility had caused his non-Hodgkins lymphoma, a disease associated with exposure to the chemical. Additionally, the U.S. EPA was conducting air monitoring around the plant.
“Soon after this evolving story first broke, we started monitoring it for our customers who utilized Sterigenics,” said Bindiya Vakil, CEO of Resilinc.
This first alert was followed by a second on September 27 notifying the 21 Resilinc customers that Sterigenics faced additional lawsuits from neighbors of their Willowbrook facility. At that point, Resilinc raised the level of supply chain disruption potential from “low” to “medium.”
Resilinc could offer these early warnings because of the robust capabilities of its EventWatch system. Fine-tuned over many years, EventWatch monitors more than 100,000 news sources in 53 languages and uses AI and machine learning to filter terabytes of information and identify events that could affect the supply chains for any of Resilinc’s more than 15,000 customers. Alerts are issued immediately by the automated system, with likely impacts ranked from “low” to “severe” and recommendations for mitigating the potential impacts.
Through the rest of 2018 and into early 2019, Resilinc’s customers were notified of multiple types of events that had the potential to compound the EtO sterilization challenges for the medical products industry. Illinois political leaders and community activists were ramping up their criticisms of Sterigenics. Illinois Congressman Daniel Lipinski introduced legislation in November that would require U.S. EPA to review and revise, if necessary, EtO regulations.
To hear more about Resilinc solutions for healthcare and life sciences, go to healthcare.resilinc.com or read the Biogen case study at https://info.resilinc.com/proactive-risk-mitigation-in-hurricane-season