This past February, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop Sterigenics from sterilizing medical products and other products with ethylene oxide at their Willowbrook, Illinois, facility. The state EPA Order was due to the presence of levels of EtO higher than the EPA found to be acceptable in the air around the facility. This closure caused a temporary shortage of pediatric breathing tubes.
Another Sterigenics contract sterilization facility, in Atlanta, Georgia, has been closed since August while it undergoes construction to reduce EtO emissions. In October, the Sterigenics Willowbrook, Illinois, facility announced they would not reopen.
Georgia is also seeking a temporary restraining order to close a Becton Dickinson (BD) EtO plant in Covington, Georgia, where a leak of 54.5 lbs. of the gas went undetected for eight days in September. BD pledged in August to install $8 million worth of emissions-control equipment at its two Georgia EtO plants, but the state alleges the company has been dragging its feet.
After a preliminary injunction hearing on Monday, October 28, 2019, BD announced it signed a consent order with the Georgia Superior Court that ends a suit brought by the Peach State’s Environmental Protection Division (EPD). The deal requires the company to keep pursuing the emissions-control project it launched in August and to voluntarily suspend operations from October 30 to November 6 to allow Georgia’s EPD to take air samples when the sterilization systems aren’t running.
The EPA is expected to update its regulations of the gas by March 2020.
FDA Recommendations
The FDA says it recognizes that there are concerns associated with release of EtO into the environment if emissions were to occur at unsafe levels.
However, because the number of EtO contract sterilization facilities in the U.S. is limited, the FDA says it’s very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations.
“The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care.
“This is why today we are urging medical device manufacturers that use EtO facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution.”
“We also encourage health care facilities to perform similar inventory assessments of critical medical supplies that undergo contract terminal sterilization via ethylene oxide prior to shipping and reach out to the FDA so we can assist in any way we can to help identify sources of potential substitute devices.”
“We also encourage device manufacturers and health care providers to provide us with information on potential supply issues. We have a device shortages mailbox so that any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us. It’s never too early to contact us—the sooner we are aware of a potential shortage, the better we can assist in proactively developing a plan to mitigate its effects on patient care.”
The FDA will hold a public advisory committee meeting on November 6 and 7, 2019, dedicated to discussing how best to encourage innovation in medical device sterilization. It will also continue to collaborate with the U.S. EPA.
