Coming up short?

Supply disruption related to EtO plant closures difficult to measure

Questions remained in late October about the capacity of commercial EtO sterilization facilities.

The anticipated reopening of the Atlanta, Georgia, facility of Sterigenics was still on hold at press time due to drawn-out discussions with Cobb County officials about fire codes and other regulations. There was no firm date for its reopening.

Meanwhile, the Oak Brook, Illinois-based contract sterilization firm announced in September that it would permanently close its suburban Chicago plant.

And on Sept. 13, the Environmental Protection Agency announced it would request information from the public and commercial sterilization companies about proposed EtO control technology options and costs for more than 100 commercial EtO sterilizers nationwide. The agency is addressing EtO emissions as part of its review of two National Emissions Standards for Hazardous Air Pollutants (NESHAP).

Through it all, getting a grip on exactly how – or if — these disruptions were affecting the supply chain was no easy task. Several distributors and manufacturers contacted by JHC declined to comment. Only one – Medtronic – offered a statement, and it lacked specifics: “We use a diverse mix of sterilization sources to ensure adequate supply of our therapies for patients, mitigate risk, and ensure business continuity. We are well positioned to continue to serve patients.”

Sterigenics’ Sept. 30 announcement of the Chicago-area closure reflected the firm’s frustration with local regulatory bodies, while reassuring the industry that products would continue to flow.

“Hospitals and patients around the United States and the world depend on Sterigenics for vital, sterilized medical products, and we cannot provide them with the certainty they require while operating safely in a state that will suspend operations of a business despite the company’s compliance with applicable rules and regulations,” the company said. “We are actively taking steps to ensure customer and patient needs continue to be met by our other facilities, and are working with our employees throughout this transition.”

What happened?
The buzz is about ethylene oxide, or EtO, a gas used to sterilize billions of medical devices every year.

For decades, hospital central sterile departments and ORs have recognized the health hazards of chronic EtO exposure – including cancer — and have taken steps to protect their workers. But over the past six months or so, the issue has caught the public eye, as neighbors of commercial EtO facilities have sounded the alarm about emissions in their communities.

Sterigenics says its nine facilities (not counting the shuttered Chicago-area facility) meet or exceed EPA standards for EtO emissions. Likewise, Medline maintains that EtO emissions from its plant in north suburban Chicago – also the subject of local scrutiny — “have always been at or below the standards set by regulating bodies.”

The scientific debate will continue: Are the controls currently in place in EtO sterilization firms around the country adequate to prevent incidences of cancer in surrounding communities?

One thing seems clear: A ban on EtO – though highly unlikely — would result in a public health crisis. Medline estimates that more than 50 percent – or 20 billion – healthcare products are sterilized with EtO every year in the United States alone. And, at this point in time, there’s no better sterilization agent that can effectively sterilize the myriad of materials found among today’s medical devices and surgical packs.

Responses
Sterigenics’ plant closures are further proof of the need for the healthcare industry to improve its preparations for product disruption, says Chaun Powell, group vice president, strategic supplier engagement, Premier Inc. In the past year, Charlotte, North Carolina-based Premier has assembled a product disruption team in response to the “rampant increase” of disruptions seen in recent years, including those caused by weather-related events, says Powell.

Six months ago, Premier interviewed 15 major manufacturers to learn about their emergency preparedness procedures. More recently, the GPO contacted close to 600 suppliers about their sterilization protocols, to help Premier identify how and why product disruptions might occur, and what remedies or workarounds exist.

In addition, Premier said it is working with the Healthcare Supply Chain Association, the Health Industry Distributors Association, and hospitals and health systems to improve demand planning and to prevent hoarding and panic when disruptions are announced.