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 for a temporary restraining order to halt operations at BD’s Covington, Ga. plant, which uses ethylene oxide (EO), a known carcinogen, to sterilize millions of medical devices per month. The EPD claims that BD violated its state air quality permit during an eight-day valve leak in September that released 54.5 lbs. of EO into the air and that the BD plant violated another permit by “willfully or negligently allowing” EO emissions of 555.7 lbs. per year.
Today, BD warned that closing the Covington plant could lead to shortages of its Foley catheters in the U.S., Canada and Japan, where the company said it has the largest market share. Affected devices would include urinary and midline catheters, PICC lines, balloon dilation devices, oncology ports, breast biopsy needles, surgical mesh, vascular and ureteral stents, feeding tubes, and drains. It also said that after Dunn’s suit was filed, it contacted third-party EO sterilizers and learned “there is no available capacity for sterilization in North America, South America, or Europe.”
“If the (Covington) facility is shuttered, it would have immediate and potentially disastrous consequences on the supply of sterilized medical devices in Georgia and throughout the United States, which would directly impact the provision of critical medical services and patient care,” the company added. “That impact is undisputed.”
The Covington plant sterilizes approximately 15 million medical devices each month, the company noted. Since October 2018, BD has sold more than 101 million urology and critical care medical devices that were sterilized in the Covington facility. Of those, over 2.5 million were sold to patients in Georgia and composed more than 1,100 different types of medical devices, the company noted.
Customers during that time period included the U.S. Department of Veterans Affairs, which purchased more than 15 million medical devices sterilized at BD’s Covington and Madison (Ga.) EO plants. The U.S. Department of Defense bought more than 2.2 million devices and other government agencies purchased another 500,000 devices sterilized at those facilities. The Covington plant is Georgia’s largest EO sterilization facility and devices sterilized there are used in nearly every hospital and healthcare facility in Georgia, the company said.
A group of medical societies told the FDA in an Oct. 21 letter that many complex medical devices “currently have limited alternative sterilization processes available while others are suboptimal. Therefore, when considering the overall impact of regulatory changes, the organizations urge the Agency to ensure continued patient access to critical devices as well as to minimize patient costs.”
Potentially affected surgical kits include those used in emergency Caesarean sections and other emergency surgeries, and in routine procedures such as cardiac surgery and hip or knee replacement surgeries, the agency said. Other devices that could go into short supply include feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. The FDA has scheduled a public advisory committee meeting Nov. 6-7 to discuss how best to encourage innovation in medtech sterilization.
Also today, the FDA warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two other EO plants and efforts to close the Covington facility. Sterigenics permanently shut down its EO plant in Willowbrook, Ill. earlier this month after state officials there shut it temporarily in February over EO emissions concerns. Sterigenics also temporarily ceased operations at its plant in Atlanta in August to upgrade its emissions control equipment.
Yesterday’s legal action by the Georgia EPD stunned BD, according to the company. “BD has been in regular weekly (and sometimes daily) communication with EPD and the Governor’s Office since August 2019,” the company said in its response, which includes copies of written communications. “BD has met in-person with EPD officials and staff five times since June 2019… Contrary to EPD’s assertions, BD has cooperated with EPD and the State every step along the way.”
Until Dunn’s legal filing, the EPD had led BD to believe the Covington plant was in full compliance with its EPD permit and all applicable laws and regulations, the company said. As recently as Oct. 2, Governor Brian Kemp thanked BD for its efforts to keep the state updated on the company’s voluntary efforts to reduce EO emissions, BD added. The company 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 and that it failed to properly notify officials promptly of the leak.
Original Article: (https://www.medicaldesignandoutsourcing.com/bd-warns-of-international-device-shortages-in-eo-plant-court-filing/)