NEWTON COUNTY, Ga. — The FDA expressed concern Friday over a potential medical supply shortage, days ahead of a courtroom showdown between the State of Georgia and a Covington-based medical sterilization plant.
On Monday, the parties will head into Newton County Superior Court as the state moves to temporarily shut down the B.D. Bard plant off Industrial Boulevard.
The move is an effort to address what state leaders have called alarming new test results regarding the levels of ethylene oxide emissions, and a September leak at the Newton County plant.
The ETO gas is a known carcinogen, but also widely used to sterilize medical devices in only 34 U.S. facilities.
[READ the complaint here]
On Friday morning, Bard filed its response to the court, including a 600-page exhibit of test results, analysis and emails among scientists, state leaders, plant executives and Gov. Brian Kemp's office.
"…Prior to this lawsuit, EPD repeatedly informed BD that it was in full compliance with its permit and all applicable laws and regulations," the response reads, adding BD had received praise from the governor's office as recently as Oct. 2 on its progress to voluntarily reduce emissions and report updates on the September leak.
[READ the B.D. Bard court response HERE]
The filing also includes an affidavit from a South Georgia vascular surgeon, Dr. John H. Morgan, of Albany. Morgan said he relies on the Bard plant to supply his Georgia surgical centers.
"While a potential shutdown will affect our services, we are concerned about the effects of product delays on the critically ill, caregivers and health providers and others who rely on these products on a daily basis," Morgan writes.
At the same time, the FDA is weighing in, acknowledging the potential for a shortage in critical devices.
While sympathizing with concern over the overuse of ethylene oxide, it also warns medical facilities to "work together and not hoard product," in preparation for another facility shut down.
They echo much of what a medical device trade association told Channel 2 Action News earlier this week.
The hearing over a temporary shutdown of the Bard plant takes place in Monday morning in Newton County Superior Court.
Cox Media Group
