The regulatory environment regarding the usage of Ethylene Oxide (EtO) for the sterilization of medical devices is constantly evolving. Colorado state legislators are drafting a proposal that would create an additional layer of regulation on facilities that use the chemical in an effort to improve the overall air quality in the state. While the concept is well-intentioned, EtO usage is subject to comprehensive regulation by the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA).

Additionally, a similar proposal that was signed into law in Illinois resulted in the shutdown of sterilization facility. This led to a nationwide shortage of pediatric breathing tubes in 2019. CBSA works to protect timely patient access to needed therapies. The Colorado proposal would create unnecessary regulatory barriers for companies to ensure their products are safe for use by patients as already mandated and regulated by the federal government.

Colorado Proposal 

The proposal would clarify that the Department of Public Health & Environment (CDPHE) has the authority to regulate air toxins more stringently than the EPA. CDPHE would be required to establish a toxic air contaminant monitoring program which would determine the concentration of contaminants using six monitoring stations across the state. The state-level monitoring would be in addition to new annual reporting requirements on operators of major sources and synthetic minor sources of air pollution. The Air Quality Control Commission (AQCC) will evaluate these new reports along with records from existing fenceline and community-based monitoring programs to develop a list of high-risk toxic air contaminants. Working from the listing of high-risk contaminants health-based standards and emissions limitations would be created to regulate targeted chemicals. Lastly, CDPHE would have the authority to reopen any existing air pollution permits given to operators of major sources and synthetic minor sources and amend the permits in accordance with the new standards developed by the AQCC.

Background & History

For many medical devices, sterilization with ethylene oxide may be the only method that effectively sterilizes and does not damage the device during the sterilization process. Medical devices made from certain polymers (plastic or resin), metals, or glass, or that have multiple layers of packaging or hard-to-reach places (for example, catheters) are likely to be sterilized with ethylene oxide. According to the FDA approximately 50% of sterile medical devices are treated with EtO about 20 billion each year. EtO was first used as a chemical sterilant in healthcare settings in the 1950s.

The Issue: Ongoing Updates to Federal Regulations

The EPA is in the process of updating guidance on workers’ and communities’ exposure to EtO emissions while the FDA validates sterilization processes using ethylene oxide

EPA Regulations

As outlined within the Clean Air Act, the EPA regulates EtO emissions produced from commercial sterilization operations. The original rule on EtO emission was created in 1994 and updated in 2006. And in 2019, the agency began a technology review of the rule as required by law. During the technology review, the agency is examining changes in practices, processes, and control technologies, considering cost and feasibility, as well as addressing any previously unregulated emission points.

The agency is researching ways to improve their ability to measure the health risk of background exposure espouse to EtO, as they currently do not have enough confidence in monitoring measurements of background ethylene oxide to use them to estimate risk. This research objectives include:

• Enable measurement of EtO at various levels, including at concentrations lower than what are currently possible to measure at the source of EtO emissions and in the outdoor air. 
• Provide real-time testing capability to measure EtO on a continuous or near continuous basis, compared to 12- and 24-hour testing capabilities with the current method. 
• Measure EtO in areas of interest to identify potential sources.   
• Improve modeling capabilities to better understand how EtO interacts with other air pollutants in the atmosphere and estimate the movement and distribution of EtO in the environment.  

Additionally, the agency regulates workers’ exposures to EtO while working in facilities, as the chemical is also considered a type of pesticide. Pesticides are governed by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the agency is currently in the process of conducting a registration review of the chemical, which is required every 15 years. The agency states that the forthcoming release of their proposed interim decision will propose additional specific, detailed measures for reducing workers’ and communities’ exposure to EtO.

FDA Regulations

The FDA also inspects industrial facilities that sterilize medical devices and medical device manufacturing facilities to make sure that they have validated sterilization processes that meet FDA-recognized standards.

Before most sterile medical devices are on the market, the FDA reviews premarket submissions to determine if the sterility information is in accordance with internationally agreed upon voluntary consensus standards that the FDA recognizes. For ethylene oxide sterilization, two voluntary consensus standards describe how to develop, validate, and control ethylene oxide sterilization processes for medical devices and the acceptable levels of residual ethylene oxide and ethylene chlorohydrin left on a device after it has undergone ethylene oxide sterilization.

If a medical device manufacturer changes the method, process, or the facility identified in its original premarket approval submission for sterilizing its devices, the manufacturer generally needs to submit a PMA supplement so that the agency can review these changes and determine if they also meet internationally agreed-upon voluntary standards that the FDA recognizes.

Actions Taken in Other States:

As was previously noted a 2019 Illinois law allowed the state to impose stricter requirements on the chemical than those used by the FDA. The state’s environmental protection agency issued an order to a sterilization facility to stop using EtO after the state found the presence of the chemical at a higher level than what was allowed under state regulations. This order led to the closure of the facility and a temporary nationwide shortage of pediatric breathing tubes. In response, the FDA issued an alert to health care professionals, parents, and caregivers of the pending shortage and the agency helped mitigate the shortage by helping the manufacturer get a timely site change that kept supply interruptions to a minimum. The law created serious consequences for vulnerable patients and their families.