Ensuring access to safe, sterile medical devices

No matter what your industry, disruption in any part of the supply chain impacts every step that follows. For medical manufacturers, healthcare organizations, and patients, recent closures of ethylene oxide (EtO) sterilization facilities could reduce available medical devices.

Issues of safety at Sterigenics’ Willowbrook facility in Illinois first came to light in Spring 2018 after air sampling by the U.S. Environmental Protection Agency (EPA). One of the conclusions of the Agency for Toxic Substances and Disease Registry (ATSDR) noted, “If measured and modeled data represent typical EtO ambient concentrations in ambient air, an elevated cancer risk exists for residents and off-site workers.”

In February 2019, Illinois EPA Acting Director John J. Kim issued a Seal Order for the facility which handled EtO sterilization for 594 types of medical devices. By September, Sterigenics’ Cobb County, Georgia, sterilization plant – periodically idled for upgrades since August – was ordered to remain shut down until obtaining a new accurate Certificate of Occupancy.

In between these two closures, the Michigan Department of Environmental Quality (MDEQ) Air Quality Division began enforcement action when EtO emission levels at Viant Medical’s sterilization plant were higher than expected. By March, the ISO-certified medical device contract manufacturer announced it would be closing its sterilization plant by the end of 2019, stating in a letter that, “sterilization services make up a very small part of overall business model and operations.”

While it may be a small part of Viant’s operations, it’s a key part in the medical device supply chain. By October, two additional Becton Dickinson (BD) sterilization plants in Georgia were facing shutdowns but a last-minute agreement between BD and the state is allowing operations to continue as long as the company installs additional pollution control equipment.

With more than 20 billion sterilized devices sold in the U.S. – accounting for 50% of all devices requiring sterilization – reduced capacity could cause medical device shortages. This threat has kept the U.S. Food and Drug Administration (FDA) busy, working to mitigate or prevent potential shortages. Device manufacturers and healthcare providers have been asked to keep the agency updated on potential supply issues. The agency said it will fast-track sterilization site changes for Class III medical devices, changing review time from 180 days to 30 days. And, in July, two public innovation challenges were held to identify new or alternative sterilization methods (see electron beam sterilization story, pg. 12) and technologies or ways to reduce EtO emissions, details available later this year.

While the U.S. may have averted medical device shortages for now, medical device manufacturers relying solely on EtO should consider available alternatives.

Elizabeth Engler Modic, Editor
emodic@gie.net