Smith & Nephew (NYSE:SNN) initiated a field safety corrective action to update its Profix 750 grams mallet cleaning and sterilization guide after complaints regarding a potential failure mode associated with the use of the mallet, used in surgeries. Profix supplier Signal Medical received complaints regarding the failure mode in which the poly tip of the mallet may […]
EPA proposes drastic cuts to EtO emissions nationwide
The EPA has announced plans to greatly reduce industrial emissions of ethylene oxide (EtO), the carcinogenic gas used to sterilize billions of medical devices annually. The agency proposed cutting EtO emissions from industrial facilities by 93% as part of amendments to the Miscellaneous Organic Chemical Manufacturing National Emission Standards for Hazardous Air Pollutants (NESHAP) to reduce hazardous […]
How can medtech overcome its ethylene oxide sterilization crisis?
Until recently, the debate over the widely used sterilant gas ethylene oxide (EtO) has been largely waged on state and local levels in the U.S. But now it’s going public at the federal level. From city council chambers to judges’ chambers, through volleys of press releases and the clamor of citizen picket lines, the stream of information […]
BD inks deal to keep Georgia sterilization plant open
Becton Dickinson (NYSE:BDX) said today that it inked a deal with the state of Georgia to keep open a medical device sterilization plant there. Georgia is seeking a temporary restraining order to close the plant in Covington, Ga., where a leak of 54.5 lbs. of ethylene oxide gas went undetected for eight days last month. BD pledged in […]
Battles over sterilization plants intensify as industry warnings about shortages grow
The fight over plants that use ethylene oxide (EO) to sterilize medical devices is escalating across the country. New proposed legislation in Illinois would ban the use of the carcinogenic gas by sterilizers by 2021 and by hospitals by 2022, according to reports by the Chicago Tribune. A legislative hearing on the bill is scheduled for […]
BD warns of international device shortages in EO plant legal filing
The Georgia environmental chief’s effort to shut down a Becton Dickinson (NYSE:BDX) medtech sterilization plant could cause widespread shortages of commonly used devices for which BD has a large market share, the company said today in a court filing. On Tuesday, Georgia state Environmental Protection Division director Richard Dunn filed a motion with Newton County Superior Court […]
FDA warns of device shortages again due to sterilization plant closures
The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third. Potentially affected surgical kits include those used in emergency Caesarean sections and […]
Georgia seeks temporary halt to BD sterilization operation
The state of Georgia has asked a court to temporarily shutter a Becton Dickinson (NYSE:BDX) medtech sterilization plant until it complies with state environmental regulations. The Georgia Environmental Protection Division (EPD) filed a motion yesterday with Newton County Superior Court for a temporary restraining order to halt operations at BD’s Covington, Ga. plant, which uses ethylene oxide […]
Georgia to investigate BD medtech sterilization plant
The Georgia Environmental Protection Division (EPD) has opened an investigation into Becton Dickinson’s (NYSE:BDX) medical device sterilization plant in Covington, Ga. following an eight-day leak of the sterilant gas ethylene oxide (EO). The EPD notified BD this week that it was dissatisfied with the company’s reporting of the valve leak that released 54 lbs. of ethylene oxide […]
Georgia mayor wants BD sterilization plant shuttered for now
The mayor of Covington, Ga. has asked Becton Dickinson (NYSE:BDX) to temporarily shut down a plant there following a weeklong leak of the gas it uses to sterilize medical devices. A letter from Mayor Ronnie Johnston says that independent air quality tests performed for the city from Sept. 17 to Sept. 24 revealed “particularly high levels of […]
Ga. wants more emissions testing at Sterigenics’ Atlanta sterilization plant
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 […]
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