This article has been updated with a comment from AdvaMed. The U.S. Environmental Protection Agency will require medtech sterilization companies to provide information to help it formulate a new rule governing emissions of ethylene oxide. The EPA recently said that in October, it will ask for data on specific sterilization facility characteristics, control devices, work practices […]
Illinois issues construction permit to Sterigenics for EO plant
The Illinois Environmental Protection Agency on Friday issued a permit to Sterigenics to begin construction to update emissions controls at its Willowbrook medtech sterilization plant. For the plant to reopen, Sterigenics must submit plans for emissions testing and air monitoring to the state EPA. It also must provide the state agency with certification from each device’s manufacturer […]
FDA warns of more medical device shortages due to sterilization plant shutdown
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 […]
Judge approves agreement to reopen Sterigenics’ Illinois medtech sterilization plant
This article has been updated with a statement from Sterigenics. A judge in Illinois has approved the consent agreement between the state and Sterigenics that could enable the company to reopen its Willowbrook medical device sterilization plant. DuPage County Circuit Court Judge Paul Fullerton gave the nod to the agreement that the state attorney general and Sterigenics reached […]
FDA sets meeting on EO sterilization
The FDA said today that it will hold an advisory meeting on November 6 and November 7, 2019, to discuss the role of ethylene oxide (EO) sterilization of medical devices in public health, as well as the risks of the sterilization process. The general hospital and personal use devices panel of the FDA’s medical devices […]
FDA pushes duodenscope makers, users away from reprocessed devices
The FDA yesterday recommended that healthcare providers move away from a type of infection-prone duodenoscope in favor of devices that can better be sterilized, after post-market surveillance again found higher-than-expected contamination rates of “high-concern organisms.” In April the FDA revealed new data showing that rates of so-called “superbug” infections were nearly twice as high as […]
Lawsuits allege Medline, chemical supplier’s EO emissions caused cancer
A quartet of plaintiffs yesterday accused Medline Industries and chemical supplier Vantage Specialty Chemicals of releasing the ethylene oxide emissions that caused their cancer. The personal injury lawsuits, brought in the Cook County Circuit Court in Chicago, allege that Medline and Vantage Specialty Chemicals plants in Waukegan and Gurnee, respectively, allege that their leukemia and, […]
BD to spend $8m to cut EO emissions in Georgia
Becton Dickinson (NYSE:BDX) said this week it will spend $8 million to upgrade emissions controls at two medical device sterilization plants it operates in Georgia. The plants in Covington and Madison, Ga., both southeast of Atlanta, use ethylene oxide (EO) to sterilize medical devices. The federal Environmental Protection Agency recognizes EO as a carcinogen and lowered […]
These 5 DIY medical devices might surprise you
Big ideas in medical device development can come from regular people driven to solve vexing problems. Here are a handful of folks from outside the medtech industry who decided to create devices to solve their own health troubles or those of others around the world. Read on to see what high school, college and medical […]
Report: 32 new lawsuits filed against Sterigenics in Illinois over ethylene oxide emissions
This article has been updated with comments from one of the plaintiffs’ attorneys. More than 40 lawsuits have been filed against Sterigenics by people who claim that emissions from the company’s Willowbrook, Ill. medical device sterilization plant have adversely affected their or their relatives’ health, according to a report by the Associated Press. Lawyers for the plaintiffs filed 32 […]
FDA warns Innovative Sterilization Technologies on marketing language
This article has been updated with a statement from Innovative Sterilization Technologies. The FDA has issued a warning letter to Innovative Sterilization Technologies, claiming that the Dayton, Ohio-based company has been marketing its surgical device sterilization trays for non-cleared purposes. Innovative Sterilization Technologies makes the One Tray reusable sealed sterilization container intended to hold reusable medical […]
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