Medical device shortages threatening the practice of modern medicine could quickly become a reality if even a handful of commercial ethylene oxide sterilizers cease operations, top FDA officials, manufacturers and experts warned at a two-day advisory committee meeting this week.
"We would be concerned if even one additional facility shut down," Suzanne Schwartz, director of FDA's Office of Strategic Partnerships and Technology Innovation, told MedTech Dive. "We will start to see spot shortages; there is no question about that. In terms of a more catastrophic national impact, with two facility shutdowns, it is almost a certainty."
That assessment is based on outreach the agency has done with healthcare organizations, distributors and other players in the supply chain, she said.
Concern about emissions of the carcinogenic gas, used to sterilize products ranging from pacemakers to vascular stents to wound dressings, have triggered a slate of state legislative and legal actions over the past 12 months, leading to closures of several commercial facilities that help sterilize millions of medical devices each year.
Most ethylene oxide sterilization facilities are currently operating at 90% capacity, meaning companies may soon run out of other facilities to move sterilization to in the event of a shutdown because they won't have the excess or extra capacity to handle the additional devices, Chaun Powell, group vice president of strategic supplier engagement at Premier Inc., testified at the FDA panel.
"Following the closure of Sterigenics in Illinois, Viant in Michigan, and Sterigenics in Georgia, the current excess capacity is 520 million [devices]," Powell said.
"The estimated capacity at Medline in Illinois and BD in Georgia is 550 million units. Simple math shows that if those two plants close, or any similarly sized plants close, we will exceed the excess sterilization capacity for current FDA-approved facilities in the U.S."
And a senior executive at one sterilizer signaled an additional closure might not be that far away.
Lara Simmons, president of quality control and regulatory affairs at Medline, testified the company may shortly be following Sterigenics’ exit from Illinois given the legislative environment in the state.
"We are still facing legislation in Illinois that will virtually ban ethylene oxide and result in our plant closing," Simmons said.
The FDA should consider asking HHS Secretary Alex Azar to declare a public health emergency to override state legislation in order to get sterilization plants back online, advisory committee member Robert Burr, a doctor at the San Juan Regional Medical Center, said.
The United States is "on the cusp of a major medical logistical failure," Burr warned.
Schwartz told MedTech Dive the agency would have to talk with the department and the assistant secretary for preparedness and response "to determine if this would be an appropriate use for that very aggressive measure."
The administration is aware of the potential for widespread medical device shortages if ethylene oxide use is further restricted, Joe Grogan, director of the Domestic Policy Council, told reporters Friday. He did not rule out encouraging Azar to invoke a public health emergency to keep sterilization facilities open.
Throughout the two-day meeting, the expert panel spent considerable time exploring the ability of other sterilization methods to partially or fully replace ethylene oxide. Currently, only 2% of medical devices on the market have another validated sterilization method available to use, according to FDA.
The panel recommended FDA explore the use of regulatory incentives to encourage companies to pursue additional methods of sterilization as part of their regulatory submissions. Panel members said that while certain methods such as radiation sterilization could be expanded on a device-by-device basis, ethylene oxide is not fully substitutable.
"There are promising modalities for moving forward, but none that are in a position to replace EtO in the short run," advisory committee voting chair Frank Lewis said. "All of these are subject to significant technical restrictions either in terms of the materials they are compatible with or the infrastructure to utilize them will take several more years."
Experts also encouraged FDA to collaborate closely with state legislatures and governors to mitigate shortages and explore methods to cut down on the amount of ethylene oxide used during sterilization.
The ECRI Institute, a patient safety nonprofit, came out against a total ban on ethylene oxide Thursday, saying that while environmental health concerns are valid, many surgeries would not be possible without use of the sterilizing gas.
"Even a partial ban on ethylene oxide could cripple the delivery of healthcare in the United States as critical medical-surgical supplies would suddenly become unavailable," CEO Marcus Schabacker said.
The agency is currently developing legislation that would require medical device manufacturers to report circumstances that could lead to a device shortage, similar to its drug shortage authorities, according to Schwartz. The idea, which was included in HHS' fiscal year 2020 budget justification, also seeks to allow the agency the ability to temporarily import devices in emergencies.
"The reason we think it is important for FDA on the device side to have more information, more data, we could then do assessments in advance and be better prepared to address the potential for shortages and to avert them," Schwartz said. "I’m trying to identify a sponsor."
Very little time during the two-day panel was spent on the cancer risks stemming from ethylene oxide, but one patient advocate from Georgia, Kimberly Nubel of Stop Sterigenics, expressed dismay about the presence of ethylene oxide emissions near her home and local schools.
"The current statements being made about device shortages by the FDA are highly irresponsible and show undue influence on the FDA by industry lobbyists," Nubel testified.
FDA does not have oversight authority over ethylene oxide emissions, agency officials noted during the two-day meeting. That responsibility is within the purview of the Environmental Protection Agency.
"We recognize the public's concern for unsafe levels of ethylene oxide, and we share the public's objective to reduce an over-reliance on ethylene oxide for medical device sterilization," Ryan Ortega, a reviewer in FDA's device center, said. "At the same time, FDA has a responsibility to safeguard the availability of sterilized medical devices patients depend on for their health and hospitals require for healthcare."
On Wednesday, EPA Administrator Andrew Wheeler touted new proposed regulations on miscellaneous organic chemical manufacturing released by the agency as the first step towards addressing ethylene oxide emissions on a national level.
The proposed rule, which EPA estimates will result in a 93% reduction in emissions from covered facilities, floats new requirements aimed at reducing ethylene oxide use, including upgrades to process vents, storage tanks and other equipment.
"This proposal would reduce other hazardous air pollutants from our nation’s air, while providing improved compliance measures for industry," Wheeler said in a statement.
But while the proposed rule acknowledges that "small quantities of ethylene oxide emissions can present significant cancer risks to surrounding communities," it calls into question EPA’s own unit risk estimate for the chemical, saying the value could be as much as five times lower due to modeling uncertainties.
AdvaMed praised the EPA, arguing preliminary test results also released by the agency Wednesday validates the trade lobby’s argument that ethylene oxide is present in the air, even when a sterilization facility is not nearby.
"EPA's data shows that ambient air levels of EtO are far higher than the proposed standard that some have used as justification to shutter sterilization facilities," AdvaMed said in a statement. "This demonstrates that the standard is not a reliable or useful gauge for determining appropriate emission levels of EtO."
The device industry is still waiting on EPA’s approach to regulating commercial sterilizers, with the agency planning to issue an advanced notice of proposed rulemaking in the coming weeks that will more directly affect medical device companies. On Oct. 28, the White House Office of Management and Budget received the regulation for review.
EPA previously said it will convene a small business panel and collect public comment before taking "significant regulatory action" on such sterilizers.
"For commercial sterilizers, we're in the process of seeking additional data and information to inform the review of the rule and ensure we have a solid database record for our rulemaking," EPA Deputy Director of the Office of Air Quality Planning and Standards Mike Koerber told the FDA advisory committee panel. "We know a lot about what is coming out of the stacks that might be a result of what is going through a pollution control device, but we're also learning there are leaks and fugitive emissions that we don't have a good handle on and that will take more aggressive emission reduction measures."