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 […]
sterigenics
Sterigenics ethylene oxide plant to reopen
This story has been updated to include information and comments from the state of Illinois. Sterigenics and the state of Illinois Environmental Protection Agency have reached a consent agreement to reopen the company’s Willowbrook medical device sterilization plant. The proposed agreement resolves all of the current litigation between the state attorney general’s office, the DuPage County […]
FDA is looking for options amid medtech’s sterilization crisis
The FDA has issued a pair of challenges to encourage the development of new approaches to medical device sterilization. The first challenge focuses on identifying alternatives to ethylene oxide (EO) sterilization methods. The second seeks input on reducing EO emissions. The agency warned of possible medical device shortages in March following the abrupt closure of a Sterigenics EO plant in Willowbrook, […]
Sterigenics moves to upgrade shuttered device sterilization plant
Sterigenics said today that it has applied for permits to upgrade emissions controls at its Willowbrook, Ill. medical device sterilization plant, which had sterilized thousands of devices daily until its Feb.15 shutdown. The Illinois Environmental Protection Agency (EPA) closed the Willowbrook plant, citing excessive emissions of the sterilant ethylene oxide (EO), based on a federal […]
How should medtech manufacturers cope with sterilization plant closures?
The sudden closure of a medical device sterilization plant in February and a second plant closure planned for later this year have raised questions about the effects on medtech manufacturers. Medical Design & Outsourcing asked Dan Fowler of WuXi AppTec about the implications and options for the industry. MDO: What can medtech manufacturers do to mitigate the impact of the […]
Federal judge boots Sterigenics suit to state court
A federal judge has dismissed a lawsuit that Sterigenics brought against the state of Illinois for ordering it to shut down a medical device sterilization plant, saying the matter belongs in state court. The Broadview Heights, Ohio-based company abruptly closed the plant in Willowbrook, Ill. Feb. 15 after the Illinois Environmental Protection Agency ordered the plant’s […]
More device shortages pegged to sterilization plant shutdown
More medtech companies are experiencing shortages of medical devices due to the sudden closure in February of a Sterigenics sterilization plant. Officials from Cardinal Health (NYSE:CAH), and Guerbet (EPA:GBT) have written letters to customers indicating that certain devices are already in short supply or may experience shortages, Medical Device & Outsourcing has learned. The letter from Cardinal Health (Dublin, […]
EO plant shutdown leads to pediatric breathing tube shortage
The February shutdown of an ethylene oxide (EO) sterilization plant has produced the first temporary medical device shortage, according to the FDA. The device in short supply is the Bivona tracheostomy tube manufactured by Smiths Medical and used by many pediatric patients. The FDA anticipates the tube will be made available again the week of April 22, according to […]
Sterilization plant closures: Here’s why you need to care
The recent shutdown of a Sterigenics medical device sterilization plant in Willowbrook, Ill. has affected medtech giants such as Becton Dickinson (NYSE:BDX), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Smith & Nephew (NYSE:SNN) and Stryker (NYSE:SYK), according to an FDA list of devices processed at the sterilization plant. Medium-sized and smaller firms, including Teleflex (NYSE:TFX), Arthrex and ArthroCare also had devices processed there. The Willowbrook plant sterilized 594 types of devices, including sutures, clamps, […]
Another medtech sterilization plant will close in 2019
A second medical device sterilization plant is slated to close this year, prompting the FDA and medtech manufacturers to scramble for replacements. The FDA warned on March 1 about a potential medical device shortage due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. […]
FDA warns of potential medical device shortage following Sterigenics plant shutdown
FDA is warning of a possible shortage of sterilized medical devices — and an accompanying threat to public health — due to the recent shutdown of a Sterigenics plant in Willowbrook, Ill. linked to emissions of the highly carcinogenic chemical compound ethylene oxide. Agency officials believe that more than 100 medtech manufacturers and hundreds of devices may be […]