Impact of small flaw in a Dutch reactor serves as a reminder of fragile medical supply chains

A small deformation in a pipe was recently discovered in the high-flux nuclear research reactor in Petten, Netherlands (HFR). And while that may not sound too alarming, this single flaw in one facility upended the global supply of isotopes required in diagnostic imagining around the world, illustrating not only the interdependence but also the fragility of medical supply chains. 

The Netherlands reactor produces molybdenum-99 (“Mo-99”) and its decay byproduct technetium-99m (“Tc-99m”)—which happens to be the most commonly used medical isotope in the world. In the U.S. alone, Tc-99m is used in over 50,000 medical procedures each day to scan organs and other body parts to diagnose medical conditions. 

The world’s Mo-99 supply and the critical isotope byproduct depend on just six reactors: HFR (Netherlands), BR-2 (Belgium), LVR-15 (Czech Republic), MARIA (Poland), OPAL (Australia), and SAFARI-1 (South Africa). This limited network creates a systemic vulnerability with global healthcare providers heavily reliant on uninterrupted production from these reactors. And, while the effects of HFR’s outage have since been mitigated, this instance reveals just how acute this risk is.

Without a buffer, impacts flow directly to patients

The temporary shutdown coincided with scheduled maintenance of other Mo-99 reactors that saw Poland’s MARIA reactor offline through November 7. 

The unique attributes of Mo-99 production amplify the long-term risk of disruption. Global demand is increasing with an approximate jump of 44% from 2022 to 2023 in federal contracts awarded to U.S.-based TC-99m generator manufacturers and their known customers. But with a half-life of just 66 hours, Mo-99 cannot be stockpiled. Any delay in production, therefore, ripples across the supply chain almost immediately, threatening patient diagnostics and treatment timelines.

In the U.S., major Tc-99m providers like Curium U.S. LLC and Lantheus Holdings Inc. source Mo-99, directly or indirectly, from European reactors. These companies supply not only private healthcare providers but also U.S. government agencies, including the Department of Defense and the Veterans Administration. 

SHINE Technologies Inc. in Wisconsin, with support from the National Nuclear Security Administration, is attempting to ramp up domestic supply, aiming to meet over one-third of global Mo-99 demand through a facility expected to be operational by 2027. However, this project has yet to offset current dependencies. Previous efforts to establish a domestic supply have faced hurdles, as demonstrated by Northstar Medical Radioisotopes’ 2023 decision to cease Mo-99 production due to an inability to compete with foreign government subsidized competitors and rising raw material and reactor irradiation costs.

Isotope disruption illustrative of larger vulnerabilities

The sudden and unexpected risk to some 50% of Tc-99m production because of a single incident serves as another flashpoint in the global supply chain crisis and a reminder of the fragility of the supply chains healthcare providers depend on. From operational and product risk to the near constant threat of cyber attacks, medical supply chains are especially susceptible to disruption. And yet, they’re among the most essential to protect. 

There are several industry and regulatory initiatives underway, including the Food and Drug Administration’s Software Bills of Material (SBOM) requirements for medical device manufacturers and industry- or network-approved cybersecurity provider programs, designed to boost up the sector’s defenses against future risk and eliminate compromised suppliers today. Technology-centric solutions that provide greater visibility and insight into software and supplier ecosystems not only empower providers to keep up with increasing regulatory requirements but also offer the only approach that can keep up with the scale and complexity of global healthcare supply chains and networks.  

The road to resilience

There’s no single answer to avoiding this kind of risk and disruption, but rather a series of coordinated steps and investments needed to fortify medical supply chains. The vulnerability of critical supply chains demands better visibility and proactive risk management. Healthcare providers, government agencies, and manufacturers must work in sync to boost domestic production capabilities, better predict potential disturbances, identify alternative suppliers, adjust inventory levels and modify their procurement strategy.