Sterilizing plant fights effort to shut it down

Acting FDA chief warns of medical device shortage from closures.

A medical sterilization company fired back at Georgia regulators seeking to shut down its Covington facility, saying in a court filing Friday that its operations are safe and that there’s no scientific proof its emissions are harmful to the public.

If a court orders the Becton

Dickinson plant to halt sterilizations with the carcinogenic gas ethylene oxide, it could cause far greater harm to the millions of patients in need of the medical devices it sterilizes each year, lawyers for the company said in the filing.

Also on Friday, a top official at the U.S. Food and Drug Administration warned that continuing closures of sterilization facilities could lead to a national shortage of critical medical devices — including surgical kits used in emergency C-sections and feeding tube devices used in neonatal intensive care units.

Sterigenics, a medical device sterilizer that has a facility temporarily shuttered near Smyrna, recently announced it would not re-open its sterilization facility in Willowbrook, Illinois.

“At this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices,” the statement from acting FDA Commissioner Norman E. “Ned” Sharpless said.

The warnings from BD and the FDA raise the stakes in the state’s litigation. BD is one of two sterilizing plants in the Atlanta suburbs that have come under intense scrutiny from the public and Georgia environmental regulators over emissions of ethylene oxide.

A federal report released last year flagged census tracts near the plants for potentially high cancer risks from prolonged exposure to the chemical.

BD and Sterigenics in Cobb County insist their operations pose no risk to public health, but each agreed to upgrade their emissions controls. Sterigenics closed to complete its improvements, but the plant remains shut down over a dispute with Cobb officials over its building permit.

Last week, Covington city leaders requested BD suspend operations after air testing indicated elevated levels of the gas. BD refused.

On Monday, Attorney General Chris Carr filed suit in Newton County Superior Court on behalf of Gov. Brian Kemp and state environmental regulators. The complaint cited a recent leak of the toxic gas that took place over an eight-day period, attributed to a valve being left open.

The state says the plant violated the Georgia Air Quality Act by failing to properly report the leak of 54.5 pounds of ethylene oxide from Sept. 15-22.

The complaint alleges BD “failed to recognize or disclose the duration and extent of the release,”initiallystatingitlasted only one day and totaled two pounds. During the time of the release, the state alleges, BD was not in compliance with its permitrequirementstodestroy more than 99% of ethylene oxide used.

The state wants BD’s operations suspended until the company can prove that it has reformed its operations and upgraded its emissions controls.

In its response, BD said the company notified the state of the leak even though it was not required to do so because the release was below regulatory thresholds. The state has offered no evidence that BD’s emissions are responsible for the elevated levels of ethylene oxide detected in Covington’s test, the court filing said.

Further, BD’s filing said that in an August town hall in Marietta, the state Department of Public Health told the public there were no known public health risks from the Covington plant. An analysis of zip code data, health officials said, “did not show increased rates of cancer overall, nor for any of the cancers known to be associated with ethylene oxide,” according to the filing.

Sterilizers and chemical industry groups contend the EPA’s thresholds are too strict and don’t take into account ambient sources of ethylene oxide, such as diesel exhaust.

Until the state’s complaint, the Georgia Environmental Protection Division had repeatedly said BD was in compliance with the law, according to the company’s court filing. BD said it has already implemented the fixes demanded by the state in its complaint.

A spokeswoman for Carr’s office declined to comment beyond the state’s complaint, which contends BD failed to make documented progress toward curtailing emissions.

“BD has failed or refused to recognize the urgency EPD believes is necessary to accomplish a reduction of ethylene oxide in a timely manner and act accordingly,” the complaint says.

A medical device crisis?

BD has long contended that a larger crisis could be looming with a nationwide shortage of sterilized medical devices while environmental activists and the news media are overstating the airborne risks of ethylene oxide.

On Monday, six medical societies penned a letter to the FDA saying that while they support minimizing ethylene oxide emissions, there are few alternatives for sterilizing complex devices such as pacemakers and leads, angioplasty balloons, cardiac catheters, stents and guiding sheaths.

Later in the week, the head of an industry trade group said: “If the BD Covington plant shuts down, there will be three facilities in two states unable to sterilize critical medical devices. More than one billion medical devices are at risk.”

Acting FDA Commissioner Sharpless said Friday that when Illinois ordered the Sterigenics plant in Willowbrook to stop sterilizing, it caused a temporary shortage of pediatric breathing tubes. The FDA is asking medical device companies that use ethylene oxide to check their inventories for any potential shortages should their sterilizing plants be shuttered.

“The impact resulting from closure of these and perhaps more facilities will be difficult to reverse, and ultimately could result in years of spot or nationwide shortages of critical medical devices, which could compromise patient care,” Sharpless’ statement said.

The FDA also has tapped the private sector to develop alternatives to ethylene oxide sterilization.

The state will make its case to halt BD’s sterilization operations on Monday before Newton County Superior Court Judge Eugene Benton.