Georgia state officials want more test results from Sterigenics before they will allow the company to reopen its medtech sterilization plant in Atlanta. In a letter dated Wednesday, the state Environmental Protection Division (EPD) told Sterigenics to test new emissions-control equipment that the company installed after voluntarily closing the plant Aug. 26, and to report […]
Surgical staplers top ECRI’s list of top medtech hazards
ECRI Institute said today that surgical stapler misuse is the top health technology hazard, beating out the likes of point-of-care ultrasounds and sterile processing errors. The ECRI Institute said it intends to help surgical stapler users avoid many of the common errors that can lead to patient harm by publishing the 13th edition of its Top […]
BD Georgia sterilization plant leaked 54 lbs. of ethylene oxide in September
A weeklong valve leak at a Becton Dickinson (NYSE:BDX) medtech sterilization plant in Covington, Ga., released 54 lbs. of ethylene oxide into the air, according to a City of Covington incident report obtained by a local TV station. The plant began experiencing intermittent elevated levels of EO indoors Sept. 15, but inspections and systems checks failed to locate the […]
A ‘rolling effect’ on medtech sterilization plants?
The types of regulatory hurdles that contributed to the permanent closure this week of the Sterigenics medtech sterilization plant in Willowbrook, Ill., have created a “rolling effect” on ethylene oxide (EO) plants around the country, according to an industry official. The state of Illinois temporarily shut down the Willowbrook plant in February over emissions of EO, a […]
Maquet recalls arterial filters
Getinge subsidiary Maquet Cardiovascular is recalling its Quart arterial filter, used during coronary bypass surgery, because transportation may compromise its sterile packaging. A transportation simulation test revealed the problem, according to an August 27, 2019, letter to customers. Patients who are exposed to non-sterile medical devices while undergoing extracorporeal circulation may develop an infection and […]
Sterigenics to abandon Illinois plant
Sterigenics said yesterday that it’s planning to shutter an Illinois plant that uses ethylene oxide to sterilize medical devices, little more than a week after winning approval to reopen the facility. The Illinois Environmental Protection Agency moved last year to temporarily close the plant, which shut down in February, citing excessive emissions of EO, a […]
Cleaning contractor glitch prompts Zimmer Biomet recall
Zimmer Biomet (NYSE:ZBH) last week released a letter advising hospitals and surgeons that it would be recalling various Legacy Biomet products that underwent cleaning processes that could result in elevated levels of bacterial endotoxin and residual debris. Warsaw, Ind.-based Zimmer Biomet said a supplier who performs final cleaning operations on some of its products received a […]
U.S. EPA readies new rule on EO emissions
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 […]
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