The state of Georgia has filed a complaint against BD saying its local medical device sterilization plant had an ethylene oxide gas leak last month and has requested that the facility be temporarily shut down.
Room-temperature ethylene oxide gas is used to sterilize about half of all medical devices in the U.S., according to the FDA—especially common products made of materials that can’t be cleaned by heat or steam, such as wound dressings, stents or surgery kits. Both federal and state environmental protection agencies also consider ethylene oxide to be carcinogenic.
Located in Covington, Georgia, about 35 miles outside of Atlanta, BD’s plant cleans and sterilizes millions of devices per year. For a week in September, a leak at the facility released 54.5 pounds of ethylene oxide into the atmosphere and neighboring area, according to Georgia’s attorney general’s office, which said it determined the leak was caused by operator error and not an equipment malfunction.
“In addition, BD has failed to take all responsible precautions to prevent fugitive emissions of ethylene oxide in a timely manner” as required by state regulations and air quality permits, the office said in a statement. In court documents, the state said the facility allowed 555.7 pounds of ethylene oxide gas to escape per year. However, its state permit allows for up to five tons of faculty-wide ethylene oxide emissions annually.
The state’s Environmental Protection Division (EPD) filed for a temporary restraining order against the devicemaker, saying that operations should be halted until all technicians are trained on valve operation in the facility and blanks are fit on all vacuum exhaust valve outlets to prevent gas flow regardless of the valve’s position. The state agency said the company should also install pollution control equipment to capture stray gases.
In August, the agency said it would begin measuring air quality and ethylene oxide levels around BD’s Covington plant—as well as at a similar sterilization facility operated by Sterigenics in nearby Smyrna, Georgia, where a leak was reported later that month (PDF). At the time, both Sterigenics and BD had previously agreed to voluntary actions to reduce emissions and install new hardware.
“Despite Governor [Brian] Kemp and EPD’s attempts at continued, transparent communication, the state believes that BD has failed to be a cooperative partner and has not demonstrated to EPD that it has made progress toward reducing ethylene oxide emissions at its Covington facility,” the state attorney general’s office said in its statement this week.
The medical device trade association AdvaMed said that the move to shut down the plant, even temporarily, could put more than a billion devices at risk. Two ethylene oxide sterilization facilities in two states have already stopped operations.
“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,” AdvaMed President and CEO Scott Whitaker said in a statement. “Even those entering intensive care units in the coming days could see delays in their care or lack of availability because every patient requires a catheter that must be sterilized with [ethylene oxide].”
“Ethylene oxide for medical device sterilization is absolutely critical to the health of millions of patients around the country, which is why companies that use [ethylene oxide] take their responsibility to protect workers and surrounding communities extremely seriously,” Whitaker added. “They use the best available technology to destroy, capture, or otherwise limit [ethylene oxide] exposure to well within scientifically validated safe levels.”
Earlier this year, the FDA worked to avoid rippling device shortages after an Illinois environmental protection order led to the closure of a Sterigenics facility in Willowbrook, outside Chicago. The agency aimed to secure alternate locations for the devices processed and worked with manufacturers to transition them to other sites or methods.
In early September, a local judge issued a consent order that would allow the facility to resume operations, after the company had reached an agreement with the state involving the installation of new pollution control equipment, according to local reports.
Editor's note: This story has been updated regarding a recent order allowing Sterigenics' Willowbrook facility to resume operations.