Author: C. Jason Rawlings (CRCST) | Director of Clinical Services
Last year, when two sterilization facilities shut down, the FDA turned its attention to an important tool in the sterilization belt: ethylene oxide (EtO) sterilization.
Both facilities—one in Illinois and one in Georgia—shut down because of EtO emissions. In one case, the shutdown was required by a state order from the Environmental Protection Agency. On the other, the shutdown was temporary, to enable construction for improving EtO emissions. Both cases lit up the FDA’s radar
Closed sterilization facilities multiply the risk of medical device shortages, which can have adverse effects on patient care. As the governing body responsible for medical devices, the FDA initiated a series of efforts to address the growing concern about EtO.
One key effort is a pilot program involving both manufacturers and sterilizing bodies—but before we jump into that program, let’s get our bearings on what exactly EtO is:
Ethylene Oxide Sterilization: What It Is and Why It Could Be a Problem
A flammable, colorless gas, ethylene oxide is used to sterilize devices and equipment (such as those made of certain plastics, metals, or gas) that may be damaged if they are sterilized by steam. An estimated half of all medical devices in the U.S. are sterilized using EtO, making it a crucial part of sterilization processes.
The problem is that EtO can actually cause health problems. According to the FDA, “long-term exposure to ethylene oxide can irritate the eyes, skin, nose, throat, and lungs, and harm the brain and nervous system, causing side effects such as headaches, memory loss, and numbness.” EtO has also been tied to cancer.
The most recent National Air Toxics Assessment identified EtO as a potential concern in several parts of the country, so the Environmental Protection Agency (EPA) has its eye on the gas. Last February, the Illinois EPA gave a state order that stopped the EtO sterilization of medical products at Sterigenics’ facility in Willowbrook, Illinois, because of high levels of EtO in the air around the facility. “This closure caused a temporary shortage of pediatric breathing tubes,” the FDA reported in October.
This situation demonstrates the catch-22 of EtO sterilization: Without it, medical facilities lack the tools they need to carry out life-saving procedures, but using EtO sterilization risks the health of sterilization workers and those who live, work, and play close to sterilization facilities.
The Pilot Program
The FDA recognizes the problems tied to EtO sterilization. The agency wants to find ways to improve emissions and lower the use of EtO—and it wants to do these things without causing equipment shortages that exacerbate an already strained healthcare system. This is where the new pilot program comes in. Announced in late November, the Ethylene Oxide Sterilization Master File Pilot Program is beta testing a way to speed up the approval of changes to sterilization sites and processes.
“Before most sterile medical devices are on the market, FDA reviews premarket submissions to determine if the sterility information is adequate. … If a medical device manufacturer changes the method, process, or the facility identified in its original PMA submission for sterilizing its devices, the manufacturer generally needs to submit a PMA supplement so the Agency can review those changes.”
The new pilot program simplifies this process by enabling manufacturers to reference a Master File submitted by their sterilization provider. Here’s how it works:
First, whenever a sterilization provider makes changes to its facility or processes in order to reduce EtO concentrations used, the sterilization provider submits a Master File to the FDA. Then, the manufacturers (whose devices are affected by the changes) reference that Master File in the postapproval report that they send to the FDA. This enables the FDA to understand more quickly why the manufacturer has changes to report and it expedites the evaluation process.
The program relies heavily on sterilization providers, who must do the initial reporting in order to lighten the load carried by manufacturers, but it’s a step toward speedier processes in a landscape where EtO sterilization is (and should be) changing. In a recent email to Censis, the FDA confirmed that the agency is still accepting submissions to participate in the program.
Paving the Way for Change: FDA Innovation Challenges
Before announcing the pilot program, the FDA last summer rolled out two innovation challenges involving EtO. The first is to identify new or alternative sterilization methods to use instead of EtO. The second is to develop strategies for reducing EtO emissions from sterilization facilities.
Overall, FDA received 46 applications for the two challenges and selected 12 participants. The participants are now working directly with the FDA on their ideas and innovations. It’s unclear when any results or new techniques/approaches may be released.
Looking to the Future
Humanity knows more than it used to about almost everything—and sterilization is no exception. But, as is clear with EtO, sterilization is no walk in the park.
After six months of running the EtO pilot program, the FDA will evaluate the program to see whether or not it can or should be used across the board nationally. In the next year, we may see innovations from the FDA challenges roll out to the entire sterilization industry.
The chemicals and methods we use come with risks. But what can we do to alleviate those risks?
ANSI/AAMI ST79:2017. Association for the Advancement of Medical Instrumentation (AAMI)
Performance Management & Quality Improvement. CDC. https://www.cdc.gov/publichealthgateway/performance/index.html
Performance Management: Turning Point. Public Health Foundation. http://www.phf.org/programs/turningpoint/Pages/Turning_Point_Performance_Management_Refresh.aspx
Process. A Publication of the International Association of Healthcare Central Service Material Management. May/June 2020. www.iahcsmm,org
Quality Audit – A Tool for Continuous Improvement and Compliance. https://www.mastercontrol.com/gxp-lifeline/quality_audit_tool_compliance_0810/
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