Regulatory Focus™ > News Articles > 2019 > 10 > Georgia Seeks to Shutter BD Device Sterilization Facility

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Posted 24 October 2019 | By Zachary Brennan 

Georgia Seeks to Shutter BD Device Sterilization Facility

Georgia Attorney General Chris Carr earlier this week filed a complaint in court to temporarily halt Becton, Dickinson and Company (BD) from operating its Covington, Georgia medical device sterilization facility.

Carr alleges that in September, BD released 54.5 pounds of ethylene oxide, which is often used to sterilize devices, into the atmosphere because of “a lack of diligence and prolonged operator error rather than an equipment malfunction.”

He also said that the Georgia Department of Natural Resources (EPD) worked with BD to reduce the site’s ethylene oxide emissions at the facility but BD “has not submitted a permit modification application or any other substantive document to EPD indicating that it has made progress toward reducing ethylene oxide emissions at the facility.”

Concerns about device shortages linger, especially as two other ethylene oxide facilities have or will close in Michigan and Illinois. And FDA, which also noted another Georgia sterilization site has temporarily closed, has begun the search for new ways to sterilize devices.

AdvaMed CEO Scott Whitaker said in a statement: “With these three facilities closed, procedures for urological conditions, cardiothoracic and lung cancer surgeries, retinal detachments, and tumor ablations are now in jeopardy because, for these devices, there is no other way to sterilize them properly for the patients who need them.”

Carr, EPD File Complaint against BD for Violations of Georgia Law and Rules


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