Georgia was 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 August to install $8 million worth of emissions-control equipment at its two Georgia EO plants, but the state alleges the company has been dragging its feet.
EO is used to sterilize about 50% of all devices sold in the U.S. that require sterilization – more than 20 billion medical devices per year, according to the FDA. It is a preferred sterilant for devices made from certain polymers (such as plastic or resin), metals or glass and devices that have multiple layers of packaging or hard-to-reach crevices, because it has better penetration properties than other methods and is unlikely to damage products during the process. The agency issued a pair of innovation challenges in July to identify alternatives to EO and measures to reduce EO emissions. It is planning a public advisory committee meeting Nov. 6-7 to discuss how best to encourage innovation in medtech sterilization.
Acting FDA Commissioner Dr. Ned Sharpless last week warned of “years of spot or nationwide shortages” for a number of surgical kits and implantable medical devices due to the permanent shutdown of a Sterigenics plant in Willowbrook, Ill., the BD plant in Atlanta and the Covington facility. Sterigenics voluntarily closed an EO plant in Atlanta in August to upgrade its emissions controls.
Today BD said it signed a consent order with the Georgia Superior Court that ends a suit brought by the Peach State’s Environmental Protection Division (EPD). The deal requires it to keep pursuing the emissions-control project it launched in August and to voluntarily suspend operations from Oct. 30 to Nov. 6 to allow Georgia’s EPD to take air samples when the sterilization systems aren’t running.
The Franklin Lakes, N.J.-based company said it plans to put the facility back on line Nov. 7 but pledged not to run at capacity in Covington. BD also promised not to expand production at another plant in Madison, Ga., and to “implement certain operational modifications to further reduce emissions and protect product availability for patients,” according to a prepared statement.
“BD is safely operating in full compliance with its permits [in Covington], has proactively adopted the most advanced and best available technology and is emitting a fraction of its allowable limit,” the company said. “As a result of this agreement and BD’s business continuity efforts, BD does not expect disruption to product availability at this time.
“One of BD’s core values is to do what is right — for employees, communities, customers and patients. BD would not trade employee or community safety for patient safety, but knowing that the science has confirmed the safety of the company’s operations, BD will always advocate for the patients around the world who rely on the more than 250 million devices each year that are sterilized by BD in Georgia. The company remains confident in the safety of its operations and the scientific analysis that confirms that its operations do not pose a threat to employees, the community or public health,” according to the statement.