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BD Bard gets EPD approval to amend judicial order

Staff Written News

Tia Lynn Ivey

managing editor 

In light of the rapid spread of the coronavirus, which has prompted a severe shortage of medical supplies and equipment across the country, the BD Bard plants in Madison and Covington will be temporarily allowed to ramp up the use of ethylene oxide, a known cancer-causing gas used for sterilization. 

BD Bard came under fire last year over concerns that the Covington plant produced elevated ethylene oxide emissions. Since then, the company has worked with local and state leaders, agreeing to a consent order to further reduce emissions and install updated and more efficient equipment. 

But now the need for medical equipment will temporarily override the new standards, according to the Georgia Environmental Protection Division. 

“Following discussions between EPD and the federal Department of Health and Human Services, the Food and Drug Administration, and the U.S. Environmental Protection Agency regarding the COVID-19 pandemic and impending critical shortages of medical devices sterilized by BD, the Georgia Environmental Protection Division (EPD) and Becton Dickinson and Company (BD) filed a joint motion to amend the judicial consent order in Newton County Superior Court. Today the Court issued an order approving the amendment,” said Kevin Chambers with the GEPD. “The amendment temporarily increases the number of medical devices BD is allowed to sterilize and allows BD to make temporary changes to its aeration time.  This change increases the limits on product lots sterilized per month from 600 to 825 in Covington and from 603 to 685 in Madison and modifies the minimum heated aeration period for sterilized product from 24 to 20 hours at the Covington facility.  These changes are necessary to ensure hospitals have enough sterilized medical devices available to treat the influx of COVID-19 patients.  The equipment sterilized at these facilities of specific concern include Foley catheter procedural trays, Foley catheters, PICC line catheters, and acute dialysis catheters. The second amendment changes are temporary and will only be in effect until 14 days after the Governor lifts the Declaration of Public Health State of Emergency for Coronavirus.  BD is presently installing new, more effective pollution control devices at its Covington and Madison plants, which will reduce emissions and will be placed in operation as soon as installation is complete.”

According to BD Bard officials, the new allowance will not drastically affect emission rates of ethylene oxide. 

“We want Madison residents to know that the agreement will allow BD to temporarily increase our capacity to sterilize products that are key to treating patients affected by COVID-19,” said Troy Kirkpatrick with BD Bard. “Working closely with federal and state officials, BD has determined that we can boost sterilization throughput without any meaningful increase in emissions. This is done by continuing to optimize our sterilization cycles to use less EtO per cycle and continuing with a certain level of extended aeration time. EtO cycle optimization was part of our accepted proposal to FDA’s EtO innovation challenge. BD is also nearing completion of new fugitive emission reduction technology in the BD Covington facility, which will be operational as soon as this week. Construction in Madison will begin soon after. This new technology, combined with our best available emission control technology that achieves 99.999 percent destruction of EtO emissions from the sterilization process, will significantly reduce overall emissions from our Covington and Madison facilities, even with ramped up production.”

Madison City Councilman Eric Joyce, who has been critical of BD Bard in the past, supported the new consent order because of the critical need prompted by the novel coronavirus sweeping across the state and country. 

“The decision earlier this week by the Newton Superior Court to allow a 14 percent increase in medical device sterilization volume at BD Bard’s Madison plant has my support,” said Joyce. “The threat of COVID-19 to the health and safety of our citizens is so grave, so immediate, and potentially so overwhelming, that this measure to increase sterile medical supplies is in all of our interest.  My past concerns over the use of ETO in this process can wait until after the the present crisis has ended, but in the meantime we must utilize every tool and make every sacrifice to protect our citizens.”

Kirkpatrick noted that BD Bard is committed to supporting healthcare workers across the state and country during this unprecedented pandemic. 

“We would also want Madison residents to be proud that their community is directly involved in making sure health care providers and their patients in Georgia and across the country receive the devices they need to support the response to COVID-19,” said Kirkpatrick. “BD is one of the companies on the leading edge of the fight against COVID-19 (coronavirus). Our CEO, Tom Polen, met with President Trump and the Coronavirus Task Force on Friday, March 13 to discuss ways the U.S. can ramp up diagnostic testing for COVID-19. BD provides both the sample collection devices (swabs) and diagnostic tests to help hospitals test patients for COVID-19. We also provide numerous products that help in the treatment of patients with COVID-19, many of which are sterilized in Madison. These devices include urinary catheters (Foley catheters), peripherally inserted central catheters (PICCs), midline catheters and dialysis catheters. For example, every patient on a ventilator needs a Foley catheter. BD is the largest manufacturer of Foley catheters in the world, and all of these devices that BD makes are sterilized in Georgia.”

According to Chambers, this is the second amendment to the BD consent order.  The original order was filed on October 28, 2019 and was amended on January 15, 2020.  The other requirements of the previous orders including but not limited to air monitoring remain the same.  The second amendment to the judicial consent order is posted on the EPD ethylene oxide webpage at https://epd.georgia.gov/ethylene-oxide-information under BD.

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