Lack of EtO May Trigger Orthopedic Device Shortages

On October 25, 2019, the FDA sounded alarm bells about a potential nationwide shortage of critical medical devices.

The agency was responding to state environmental protection agencies closing facilities that make a gas called ethylene oxide (EtO). The EPA considers EtO to be a carcinogen.

Specifically, the FDA noted recent closures of a Sterigenics EtO sterilization facility in Illinois, the temporary closure of another Sterigenics facility in Georgia, and the potential closure of a large Becton Dickinson sterilization facility in Georgia.

The FDA said it was “closely monitoring” the supply chain effects of closures and potential closures of facilities using EtO to sterilize medical devices prior to their use. The agency said it was “concerned” about the potential medical device shortages that might impact patient care.

Ethylene Oxide Sterilization

EtO, according to the FDA, is the most common method of sterilization of medical devices in the U.S. and is a well-established and scientifically proven method of preventing harmful microorganisms from reproducing and causing infections. More than 20 billion devices sold in the U.S. every year are sterilized with EtO, accounting for approximately 50% of devices that require sterilization.

The other sterilization methods are gamma (40.5%), e-beam (4.5%) and others such as steam and X-ray (5%).

Medical devices made from certain polymers (such as plastic or resin), metals, or glass—or devices that have multiple layers of packaging or hard-to-reach crevices—are likely to be sterilized with EtO to avoid product damage during the process. These include surgical kits used in emergency procedures such as emergency Caesarean sections (“C-sections”) and in routine procedures such as cardiac surgery and hip or knee replacement surgeries.

Device Shortages Anticipated

Without adequate availability of EtO sterilization, the FDA anticipates a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices.

“It’s important to note 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. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices,” stated the FDA.

Clean Air Versus Safe Devices

This isn’t the first time we’ve written about Sterigenics. In December 2018, we reported that Illinois’ two U.S. Senators had asked the EPA to take drastic action to tighten standards and for the FDA to convene a panel to develop alternatives to EtO.

We noted that a 2014 EPA National Air Toxics Assessment (NATA) estimated “that ethylene oxide significantly contributes to potential elevated cancer risks in some census tracts across the U.S.” One of these is the residential neighborhood around the Sterigenics plant. EPA began that monitoring because of the amounts Sterigenics has been allowed to discharge for decades.

EPA officially declared in 2016 that the risk of cancer from EtO is higher than the risk level previously used to set federal regulations.

This past February, the FDA became aware that the Illinois Environmental Protection Agency (EPA) issued a state EPA Order to stop Sterigenics from sterilizing medical products and other products with ethylene oxide at their Willowbrook, Illinois, facility. The state EPA Order was due to the presence of levels of EtO higher than the EPA found to be acceptable in the air around the facility. This closure caused a temporary shortage of pediatric breathing tubes.

Another Sterigenics contract sterilization facility, in Atlanta, Georgia, has been closed since August while it undergoes construction to reduce EtO emissions. In October, the Sterigenics Willowbrook, Illinois, facility announced they would not reopen.

Georgia is also seeking a temporary restraining order to close a Becton Dickinson (BD) EtO plant in Covington, Georgia, where a leak of 54.5 lbs. of the gas went undetected for eight days in September. BD pledged in August to install $8 million worth of emissions-control equipment at its two Georgia EtO plants, but the state alleges the company has been dragging its feet.

After a preliminary injunction hearing on Monday, October 28, 2019, BD announced it signed a consent order with the Georgia Superior Court that ends a suit brought by the Peach State’s Environmental Protection Division (EPD). The deal requires the company to keep pursuing the emissions-control project it launched in August and to voluntarily suspend operations from October 30 to November 6 to allow Georgia’s EPD to take air samples when the sterilization systems aren’t running.

The EPA is expected to update its regulations of the gas by March 2020.

FDA Recommendations

The FDA says it recognizes that there are concerns associated with release of EtO into the environment if emissions were to occur at unsafe levels.

However, because the number of EtO contract sterilization facilities in the U.S. is limited, the FDA says it’s very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations.

“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.

“This is why today we are urging medical device manufacturers that use EtO facilities to assess their inventory for any potential downstream impacts of sterilization facility closures on their product distribution.”

“We also encourage health care facilities to perform similar inventory assessments of critical medical supplies that undergo contract terminal sterilization via ethylene oxide prior to shipping and reach out to the FDA so we can assist in any way we can to help identify sources of potential substitute devices.”

“We also encourage device manufacturers and health care providers to provide us with information on potential supply issues. We have a device shortages mailbox so that any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us. It’s never too early to contact us—the sooner we are aware of a potential shortage, the better we can assist in proactively developing a plan to mitigate its effects on patient care.”

The FDA will hold a public advisory committee meeting on November 6 and 7, 2019, dedicated to discussing how best to encourage innovation in medical device sterilization. It will also continue to collaborate with the U.S. EPA.

Ortho Impact

Wells Fargo analysts spoke with medical device industry leaders to assess the potential risk to manufacturers around additional sterilization facility closures.

In an October 26, 2019 note to investors, the analysts wrote that most companies in their coverage have either already begun implementing changes to reduce EtO emissions or have plans to mitigate the risk associated with facility closures. Here’s what the companies told the analysts.

• Globus Medical, Inc. said its team is currently evaluating this situation to determine impact if any.
• Integra LifeSciences has no exposure.
• Johnson & Johnson said like many other medical device manufacturers, “we rely on Ethylene Oxide (EO) to sterilize some of our devices and equipment to protect patients. While we continually evaluate alternative sterilization technologies to match product needs, EO remains a critical sterilization method for a broad spectrum of healthcare products. We continue to monitor this evolving situation closely, and at this time we are experiencing minimal impact to the availability of our product supply across our portfolio. We have strong relationships with our sterilization partners and have business continuity plans in place where necessary. The Georgia plant closure impacted one of our suppliers, but we don’t anticipate that impacting our ability to provide adequate supply and patient treatment. The Willowbrook closing earlier this year only impacted the launch of our Vizigo Sheath within EP.”
• Medtronic plc did not anticipate any disruption to their business.
• NuVasive, Inc. reported no exposure on their end.
• Stryker Corporation said it was not an issue for them
• Wright Medical Group, Inc. reported no exposure.
• Zimmer Biomet also reported no exposure

AdvaMed and six medical societies have urged caution in limiting the use of EtO until there is a feasible action plan in place.

AdvaMed President and CEO Scott Whitaker said: “It cannot be overstated: Critical medical devices might not make it into doctors’ and surgeons’ hands if we aren’t careful as we have this important conversation about the true risk of these EO sterilization plants.”

“We absolutely understand why those who live around these plants are deeply concerned based on what they’ve heard and read. But leading toxicologists and epidemiologists are certain that media reports have been misleading, and that the communities surrounding these plants are safe. These experts need to be a much bigger part of the conversation within these neighborhoods and with policymakers.”

The Georgia settlement may be showing the way for the public to have clean air and safe medical devices.