The FDA will continue its efforts to find alternative medical device sterilization methods to ethylene oxide (EO), even though a major EO plant is slated to reopen.
Yesterday, medtech sterilization company Sterigenics and the state of Illinois announced they had reached a proposed consent agreement to reopen a plant in Willowbrook, Ill., which the state shut down in February, citing excessive emissions of EO, a carcinogenic gas. The plant had sterilized millions of devices annually — 594 types of devices, according to the FDA, including sutures, clamps, knives, stents and needles.
If approved by DuPage County Circuit Court judge, the consent agreement would resolve all current litigation between the state attorney general’s office, the DuPage County state attorney’s office and Sterigenics.
Sterigenics submitted plans in June to the Illinois Environmental Protection Agency (EPA) for emissions control and reduction upgrades to meet stricter standards imposed by a new state law. The measures Sterigenics has proposed would exceed standards set by a new state law passed in June, according to the company. Illinois state officials would have to approve the Willowbrook plant upgrades before it could reopen.
The proposed consent agreement came just two days after the FDA announced it wants public input on alternatives to EO and on reducing EO emissions. With an EO plant owned by Viant in Grand Rapids, Mich. slated to close sometime this year and stiffer regulations due from the federal EPA, the FDA said it will continue to pursue EO alternatives and measures to reduce EO use in medtech sterilization.
“The FDA continues to monitor the supply of devices sterilized in facilities that have closed or that may close and is paying special attention to life-saving, life-sustaining and critical devices,” the agency said in an email to Medical Design & Outsourcing. “Furthermore, the FDA continues to take steps to ensure that hospitals, health care providers and patients have access to medical devices that are safely and effectively sterilized and encourages participation in our two Innovation Challenges. These challenges recognize the need to reduce exposure of the public to ethylene oxide emissions and to develop innovative ways to address this concern while attending to the need for safe and effective sterilization methods. FDA believes that there is merit in encouraging development of new types of sterilization processes as well as improving the efficiency and capacities of existing processes to improve availability of sterile devices and promote public health.”
The possibility of stricter regulations on EO could hit the medtech industry hard, as it is used to sterilize 56% of medical devices, according to the trade group AdvaMed. The medtech industry has also been researching methods of reducing and removing EO emissions, including wet and dry scrubbers, catalytic and thermal oxidizers, and water barriers, as EO is water-soluble, according to AdvaMed chief lobbyist Greg Crist.
Ethylene oxide is a colorless, odorless gas primarily used in the production of several industrial chemicals, the most notable of which is ethylene glycol, according to the U.S. Occupational Safety and Health Administration. It is popular for medtech sterilization because it works at low temperatures and can penetrate device packaging, speeding the process and keeping costs down.
Current alternatives to EO include nitrogen dioxide, another low-temperature, gaseous sterilization method, and vapor-based peracetic acid. Another low-temperature option, gamma sterilization, can alter the chemical makeup of some devices, making them brittle and discoloring them, according to David Gilbert, EO sterilization consulting study director for Nelson Laboratories. Gamma may also compromise some electronic components’ functions, he added.
