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 […]
Sterilization / Calibration
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 […]
Stryker puts up $52m for TSO3
Stryker (NYSE:SYK) today agreed to pay $52 million to acquire TSO3 (TSX:TOS) and its Sterizone VP4 sterilizer. The C43¢-per-share offer works out to about C$68.4 million ($51.7 million), representing an 18% premium on the 30-day volume-weighted average share price, Quebec City-based TSO3 said. “TSO3‘s board of directors and management believe that this transaction provides the best […]
Sterifre Medical adds $8m for desktop sterilizer
Sterifre Medical said today that it raised $8 million in a Series B round for the Aura desktop sterilization device it’s developing for handheld devices. Kirkland, Wash.-based Sterifre said that it’s raised $20 million to date, including a $12 million Series A round in 2017. “Proceeds from the Series B financing will fund our initial […]
Sterigenics plant reopening delayed
The Sterigenics medical device sterilization plant in Willowbrook, Ill., will remain closed for at least five more weeks, according to local news reports. The DuPage County judge overseeing litigation about the plant’s emissions of the sterilant ethylene oxide (EO) ruled Wednesday that Willowbrook and three other municipalities that surround it can join the lawsuit. Willowbrook, […]
Report: Ethylene oxide levels high near Georgia medtech sterilization plants
This article has been updated to include comments from Sterigenics. Medical device sterilization plants in the Atlanta area have come under scrutiny from neighbors and state officials following the publication of an investigative report by Georgia Health News and WebMD. Ethylene oxide plants owned by Sterigenics in Atlanta and Becton Dickinson in Covington, Ga., reported […]
Ethylene oxide plant reopening won’t halt FDA plans to seek alternatives
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 […]