This article has been updated with a comment from Sterigenics and a correction on the location of the Georgia plant.
The FDA warned last week about the potential for more medical device shortages, this time due to the temporary shutdown of a Sterigenics ethylene oxide (EO) plant in Atlanta, Ga.
The Atlanta plant uses ethylene oxide (EO) to sterilize medical devices. The federal Environmental Protection Agency recognizes EO as a carcinogen and lowered its limits on emissions of the sterilant gas in 2016.
Sterigenics closed the Atlanta plant on August 26, 2019, so it could upgrade systems to reduce EO emissions, according to the agency. Sterigenics said in July that it had voluntarily reduced EO emissions at the plant by 90% over the past five years and that it intends to make the same upgrades there as it is adding to its EO plant in Willowbrook, Ill.
Today, Sterigenics said it expects to complete the installation of emissions-reduction equipment in its Atlanta plant by the first week in October, well ahead of its initial estimates. In July, the company said the project would take 12 to 24 weeks from the time it received permits to do the work.
“At the request of Governor (Brian) Kemp and the (Georgia Environmental Protection Division), Sterigenics has been working to expedite the installation of technology enhancements to our Atlanta facility and, as previously announced, has been operating under a reduced production schedule,” the company said in a statement emailed to Medical Design & Outsourcing. “The construction is proceeding ahead of schedule. We have determined that suspending sterilization operations, and the use of EO in those operations, throughout the duration of the work will enable us to further accelerate the installation of these enhancements and that doing so is the most efficient path to meeting the requests of all stakeholders.
“As we implement these enhancements to ensure that our facility operates in line with the highest control standards in the country, our team is also working with customers to minimize the impact on the supply of vital sterile medical products to hospitals and the patients who depend on them every day,” the company added.
The Illinois EPA shut down the company’s Willowbrook plant in February, citing excess EO emissions. Last week, a DuPage County judge approved an agreement that the state attorney general and Sterigenics reached in July that would allow Sterigenics to reopen the Willowbrook plant if it complies with a stringent new state law on EO emissions.
The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, knives, stents and needles. Its closure prompted the FDA to warn of possible device shortages and sent medtech companies large and small scrambling to find other sterilization facilities. Some larger companies were able to take the task in-house or farm it out to other contract sterilization plants. Others were not so lucky.
In April, officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) advised customers that certain devices were already in short supply or may experience shortages. Teleflex (NYSE:TFX), which had seven million devices sterilized per year at the Willowbrook plant, warned of shortages as well.
“The FDA is working to understand the impact it could have on medical device availability and communicating with Sterigenics and medical device companies that may be impacted,” the agency said Friday regarding the temporary closure.
The agency said it is also working with Sterigenics and its customers to determine if there will be any medical device shortages as a result of the Atlanta facility closure. The FDA again asked healthcare providers and organizations and the public to email the agency’s shortages mailbox (email@example.com) if they run into shortages or are concerned about the adequacy of medical devices to meet patient needs.
The FDA also reminded medtech manufacturers to reach out to the FDA if the Atlanta plant closure delays their abiity to delivery devices to customers.
“The FDA is closely monitoring this issue and will keep the public informed as warranted,” the agency said.