Medical device makers and federal regulators are on edge after the closure of two major sterilization facilities and the potential shuttering of a third next week.
They’re warning of potential shortages of medical devices if a court allows the state of Georgia to temporarily shut down sterilization operations of a Becton Dickinson, or BD, facility in suburban Atlanta next week. Georgia’s attorney general has asked a judge to grant a temporary restraining order and an injunction to shut down the BD facility, which is in Covington, until it can upgrade its pollution controls.
“It’s kind of like a tipping point right now. If there were to be any more closures then the likelihood is we will not only see spot or local shortages, it will have a ripple effect nationally,” said Dr. Suzanne Schwartz, the acting director of the Office of Strategic Partnerships & Technology Innovation at the FDA’s Center for Devices and Radiological Health.
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