Late yesterday 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.
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.
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.
News Media Contact: Kevin Chambers 404 651-7970
email: kevin.chambers@dnr.ga.gov
