By Don Sadler
Healthcare facilities rely on sterile medical devices to provide safe patient care. These include everything from endoscopes to surgical scissors and retractors. New regulations released by the Environmental Protection Agency (EPA) last year could have an impact on how these devices are sterilized, which in turn could impact device availability for hospitals and ASCs.
EPA Rule Limits EtO Emissions
Last March, the EPA released a final rule that sets new emission standards for ethylene oxide, or EtO. This is a clear gas chemical that’s used to sterilize approximately half of all medical devices used in the United States, or more than 20 billion devices per year.
EtO is a known carcinogen that the EPA has determined is more toxic than previously thought. According to the EPA, the new rule will reduce EtO emissions from commercial sterilizers by more than 90 percent. The rule is designed to protect people who live near sterilization facilities from cancer risks. It tightens emission limits for the facilities that use EtO to sterilize medical devices, including pre-packaged surgical kits and catheters with hard-to-reach parts.
According to the EPA, the rule will protect people who live near these facilities from EtO levels that could lead to a lifetime cancer risk of more than one in 100,000 people. This is the upper limit of what the EPA considers an acceptable risk.
In addition, the EPA is working on a separate set of requirements to reduce EtO exposure for employees who work in sterilization plants.
Sterilization facilities that use more than 60 tons of EtO per year have two years from the date the new rule was announced last March to meet the new EtO emission standards, while facilities that use less that one ton of EtO per year have an extra year.
Damien Berg, BA, BS, CRCST, AAMIF, vice president of strategic initiatives with the Healthcare Sterile Processing Association (HSPA), points out that the use of EtO sterilization as it relates to the new regulation primarily addresses manufacturer-performed sterilization of single-use items.
“Therefore, the new and changing regulations really impact the supply chain, rather than the reprocessing of medical devices in hospitals,” says Berg. “While HSPA recognizes the importance of EtO sterilization, it’s important to note that the majority of instrument reprocessing conducted in hospitals is done with other low-temperature methods or steam.”
Validation of Sterilization Processes
Dr. Richard Warburton, CTO and general council with ChemDAQ, explains that all medical devices must be approved by the Food and Drug Administration (FDA).
“The validation of the sterilization process is part of this approval,” he says. “So, before a given medical device can be sterilized with a new method, the method must be thoroughly validated, which is a slow and expensive process.”
“There are millions of types of medical devices,” adds Warburton. “So even if the entire industry decided to move away from EtO, it would take years.”
EtO is widely used as a sterilant because of its efficiency and material compatibility.
“EtO also has excellent penetrability, allowing medical devices to be sterilized by the pallet, rather than smaller packages,” says Warburton. “In addition, EtO is relatively low-cost compared to gamma or X-ray, with high throughput.” Gamma radiation is the second most widely used sterilization method.
According to Warburton, the EtO sterilization industry operates at close to 100 percent saturation.
“Most facilities, especially contract sterilizers, run 24/7, 365 days a year,” he says. “For a facility to retrofit new air scrubbing equipment will probably require it to shut down for several months. If several facilities shut down, there will be less capacity in the industry and some medical device sterilizations will be delayed, with no easy alternative sterilization available.”
In this scenario, Warburton says it’s likely that some medical devices used in the OR may become back ordered or have long lead times.
“The FDA is concerned and is actively working to help reduce the risk to the medical device supply chain,” he says. “But there’s a limit to what the FDA can do.”
Miniscule Emissions
Erin Kyle, DNP, RN, CNOR, NEA-BC, editor in chief, Guidelines for Perioperative Practice with the Association of periOperative Registered Nurses (AORN), says that the emissions from EtO sterilizers are miniscule in comparison to those from industrial sterilization operations.
“However, this doesn’t mean healthcare organizations are not subject to implementing engineering controls to protect healthcare workers, patients and the environment from ethylene oxide exposure,” says Kyle. “I can see these regulations renewing interest among healthcare facility designers and perioperative professionals to review their operations to identify ways they can improve their environment and processes to make ethylene oxide use even safer.”
Kyle says the EPA is proposing to require healthcare facilities to implement engineering controls designed to reduce exposure to EtO. These include:
- Separating EtO sterilization spaces from other work areas to reduce the broader circulation of EtO.
- Implementing negative air pressure in rooms containing EtO sterilization devices to ensure that air will not flow from the room with a higher EtO concentration through the rest of the healthcare facility.
- Using abatement devices that will remove EtO from the exhaust air and reduce discharge to the environment.
- Discharging exhaust air from EtO sterilization devices through exterior ventilation stacks after passing through abatement devices to reduce the amount of EtO re-entrained into the building.
Ripple Effects of the Regulations
Lillian H. Nicolette, MSN, RN, CNOR, consultant/partner with Perioperative Consulting LLC, has been a pioneer in the elimination of EtO. She is quite familiar with the new EPA regulations limiting EtO emissions for medical device sterilizers and the potential impacts on the perioperative environment.
“EtO has played a critical role in sterilizing heat- and moisture-sensitive medical devices, so these regulations are likely to have several ripple effects in the perioperative environment,” says Nicolette. These include:
- The availability of sterile devices due to potential disruptions in the supply chain.
- Shifts to and challenges with alternate sterilization methods.
- Higher sterilization costs, including the cost of alternate technologies and transitioning to alternative sterilization methods.
- Adjustments in perioperative workflow.
- Patient safety and infection control.
- Adaptation to device shortages, including increased reliance on in-house sterilization for facilities that may outsource. “This would lead to potentially higher workloads for central sterile processing teams,” says Nicolette.
- Device compatibility and performance issues.
- Environmental and regulatory compliance challenges.
- Operational oversight challenges. “Healthcare systems may need to closely monitor compliance with local and federal regulations for sterilization methods,” says Nicolette.
- Emphasis on sustainability practices. “The perioperative setting may see an emphasis on reducing environmental impacts, such as exploring reusable device options, adopting greener practices or advocating for sustainable device designs,” says Nicolette.
Kyle acknowledges concerns about the EtO emissions limits on medical device sterilizers resulting in supply chain disruptions and potential shortages of essential medical devices. “However, I believe the stepwise and calculated rollout of these regulations has allowed adequate time for sterilization facilities to adjust and prepare,” she says.
“While it remains to be seen how these changes might influence the supply chain, I have a degree of optimism that perioperative teams will have what they need when they need it even after new regulation implementation,” says Kyle. “Device manufacturers and sterilization services have been hard at work to be ready.”
Once the new rules become effective, Kyle believes perioperative teams will likely begin to see differences in the labeling of supplies that are processed in industrial sterilization facilities to reflect the changes in sterilization methods.
“Perioperative teams should familiarize themselves with the standardized labeling of sterile supplies so these changes don’t come as a surprise,” says Kyle. “There should be minimal impacts because the products they need to be sterile for use will still be delivered as sterile.”
New Sterilization Techniques
According to Nicolette, the move away from EtO to sterilize medical devices has actually been occurring over the past 30 years. “During this time, many new sterilization technologies have emerged to reduce or eliminate reliance on EtO while ensuring effective device sterilization,” she says. These technologies include:
- Vaporized Hydrogen Peroxide (VHP) sterilization
- Ozone sterilization
- Nitrogen dioxide (NO₂) sterilization
- Low-temperature plasma sterilization (Sterrad*)
- Gamma radiation
- Electron beam (E-Beam) sterilization
- Carbon dioxide (scCO₂) sterilization
- UV-C sterilization
Ronald L. Hunsucker, the “Cowboy of Clean,” is a clinical education specialist with Healthmark, a Getinge Company. Hunsucker says he has seen a trend toward sterilization via ionizing radiation. “New forms of sterilization are now available with more to come,” he says. “I recommend working with device suppliers now to standardize pricing. Starting to research now will save a lot of time later.”
Preparing for Supply Chain Disruptions
To prepare for any potential supply chain disruptions caused by the new regulations, Warburton recommends that perioperative professionals ask device manufacturers and suppliers whether their devices are manufactured and sterilized in the U.S.
“If the device is sterilized in another country, even if it’s just across the border in Mexico, the new EPA regulations will have no effect,” says Warburton. “Many of the larger medical device manufacturers have offshore manufacturing and sterilization capabilities. In the event of hold-ups in the U.S., they may be able to shift production and/or sterilization to other countries.”
Warburton also recommends identifying alternative devices, perhaps from a different manufacturer, that can perform the same function and be used as a backup. “Keep in mind that demand for these alternatives will also rise if the primary device becomes unavailable,” he says. “If there are no alternatives, it may be prudent to increase inventory, depending on the product, cost, shelf life, etc.”
It also might be worth assessing if some current disposable products can be reprocessed in-house, or if they can be replaced with products designed to be reprocessed in-house. “There is a long-standing debate for in-house sterile processing departments about whether it’s better to use disposable or reusable items,” says Warburton. “The pendulum tends to swing one way for a few years and then back again.”
Nicolette acknowledges that while the regulations aim to protect health and the environment, the transition period could introduce challenges. However, some perioperative and sterile processing staff have been preparing for these new rules for years.
“This is not something that’s new,” says Nicolette. “To continue to prepare for the implementation of the new regulations, perioperative professionals should take proactive steps now to minimize disruptions, ensure compliance and maintain patient safety.”
These steps include collaborating with vendors, manufacturers and supply chain partners; conducting a sterilization needs assessment; enhancing sterile processing capacity; building staff competency; partnering with professional organizations; monitoring compliance and regulatory updates; optimizing environmental practices; and developing a contingency plan.
“By taking these proactive steps, perioperative professionals can ensure they are well-positioned to adapt to regulatory changes while maintaining patient safety and operational efficiency,” says Nicolette.
So far, Nicolette says the conversations she has heard among perioperative professionals about the new rules reflect a mix of concerns, optimism and strategic planning. “These discussions have been ongoing for many years,” she says. “They revolve mainly around concerns about device availability, financial and operational pressures, opportunities for innovation, questions about implementation, and sustainability.
“While the new rules can be seen by some as a challenge, they are also viewed as an opportunity for perioperative professionals to advance safety, sustainability and innovation in their practice,” says Nicolette.
Ethylene Oxide Isn’t the Only Option
Kyle believes the movement away from high concentrations of EtO to safer alternatives is one that all healthcare professionals will be happy about.
“We need methods to reliably sterilize instruments and supplies, but ethylene oxide is not the only option,” says Kyle. “There has been tremendous advancement in identifying and validating novel sterilization methods that have a lesser impact on the environment and the communities surrounding industrial sterilization facilities.”
The perioperative professionals Kyle has spoken with are glad the work is being done to safely deliver sterile supplies and medical devices without them needing to be bothered with thinking about the new regulations. “That’s how it should be,” she says.
