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The Dangers of Ethylene Oxide “Gas” Sterilization for Medical Devices

The Dangers of Ethylene Oxide “Gas” Sterilization for Medical Devices

Modern practitioners, and the patients they serve, rely on the availability of sterile medical devices. Per the CDC, nearly 50 million surgical procedures are performed annually in the US. Every procedure involves contact with a medical device or surgical instrument, and your patient’s delicate tissues or mucous membranes. A major risk of all surgical procedures is the introduction of pathogens, and, ultimately, infection. Furthermore, improperly sterilized medical equipment brings forth the risk for person-to-person transmission and potential transmission of environmental pathogens.

As a practitioner or sterile supply supervisor, you probably already know that Ethylene Oxide, C₂H₄O, (EO, EtO, or ETO) is a sweet-smelling, flammable, explosive, colorless gas used for the bulk sterilization of medical devices. Its primary advantage is that it can sterilize medical equipment and instruments, which are moisture or heat-sensitive, without harmful effects on the materials used in the devices. In other words, delicate plastics and polymers won’t be subjected to the abuse of high-temperature sterilization. In theory, devices sterilized this way will have a longer usable lifetime.

That being said, ETO is volatile, costly, requires a long cycle time, and brings considerable health risks to your staff, patients, and community. These health risks, in turn, create both moral/ethical questions, and questions of financial liability to your organization.

 

Health Hazards Associated With Ethylene Oxide

 

The Risks to Your Central Supply Staff

Per the Center for Disease Control (CDC), “Acute exposure to ETO may result in irritation (e.g., to skin, eyes, gastrointestinal or respiratory tracts) and central nervous system depression.” It can cause nausea, vomiting, and difficulty thinking clearly. ETO should be treated as a carcinogen.

Furthermore, chronic exposure/inhalation of ETO has been linked to:

  • Formation of cataracts
  • Neurologic dysfunction
  • Cognitive impairment
  • Disabling polyneuropathies, also called peripheral neuropathy

Among sterile supply staffers, occupational exposure links to:

  • Hematologic changes (problems in the blood and bone marrow system)
  • Reproductive problems and an increased risk of spontaneous abortions
  • Various cancers

Your central supply techs aren’t the only ones at risk. In early 2019 the Illinois Environmental Protection Agency (EPA) issued a seal order at a contract sterilization facility, Sterigenics, due to public health hazards of ETO emissions.

 

The Risks to Your Local Community 

putting medical devices i a chamber for cleaning with Ethylene Oxide

 

In the Sterigenics situation, the EPA took ambient air samples in the spring of 2018. The Agency for Toxic Substances and Disease Registry (ATSDR, a division of the CDC) concluded that “an elevated cancer risk exists” for local residents and outside employees in the community near the bulk sterilization facility. These increased cancer risks “present a public health hazard to these populations.”

When presented with this ethics quandary, Sterigenics didn’t voluntarily shut down operations. Thus the EPA issued the seal order and forced a shutdown.

The idea that a sterilization operation could be damaging the health of locals in the community brings us to our next realization:
 

The Financial Risks to Your Organization

In our litigious era, the modern healthcare industry exists in a potential minefield of lawsuits. Imagine the damage to your organization’s reputation and the ultimate liabilities involved with a community class action lawsuit! For these reasons, ETO may soon be obsolete. Luckily, the FDA and EPA are totally on board.
 

The FDA Is Taking Steps to Move Beyond Ethylene Oxide “Gas” Sterilization

The FDA announced a public innovation challenge, meant to encourage the development of new approaches to sterilization. Specifically, the goal is to identify alternatives to ETO sterilization techniques. Their goal is to protect patients, providers, and staff, as well as outside communities.

After receiving 24 potential submissions, the FDA settled on four participants, with a total of five new sterilization methods to review, in hopes of banishing ETO sterilization. As of November 2019, the FDA intends to work closely with the participants to consider each proposed sterilization method. They’re expecting this collaboration phase to last 60 days, which puts their target end date in late January 2020.

The four participants and their strategies are:

  • Noxilizer Inc, with Nitrogen Dioxide Sterilization
  • NovaSterilis, with Supercritical Carbon Dioxide Sterilization
  • STERIS, with both Accelerator-based Radiation Sterilization and Vaporized Hydrogen Peroxide Sterilization
  • TSO3 (now a part of Stryker), with Vaporized Hydrogen Peroxide – Ozone Sterilization

It’s important to note that acceptance by the FDA does not mean these methods/technologies will be endorsed by the FDA. The regulatory standard of demonstrating a reasonable assurance of safety and effectiveness still applies. These new processes must yet be reviewed through the relevant pre-market pathways before they are marketed as ETO alternatives.
 

Meanwhile, Back at the Lab

Regardless of the FDA’s actions to find alternatives to ETO sterilization, medical professionals can rely on obp for sterile, single-use devices to protect the safety of patients every day. Our clients don’t face the risks and liabilities of ETO gas sterilization because our practitioners are using sterile, single-use, LED-lit medical devices.
 

About obp: We Are Providers of Sterile, Single-Use, Self-Lit Tools and Devices

Our staff is committed to delivering self-contained, single-use, illuminating medical devices that will improve and transform healthcare. With enormous respect for medical professionals and their support staff, we aim to cultivate a highly-collaborative and forward-thinking work environment that fosters innovation.

Our story started more than ten years ago, developing products that facilitate the transition of minimally invasive procedures commonly performed in hospitals and ORs to office settings and away-clinics. As part of this mission, we leveraged advancements in LED technology to pioneer the creation of single-use medical devices with integrated light sources.

Heightened awareness about the risks of cross-contamination, and now a need to move beyond old and potentially dangerous sterilization methods, encouraged us to expand beyond our initial focus, to other standard medical devices into sterile, single-use, cordless, illuminated tools.
 

Learn More About the Dangers of Ethylene Oxide “Gas” Sterilization

Check out our product catalog for innovative single-use devices like ER-SPECHER-SPECANOSPEC, and more. We also offer sterile, single-use medical kits, like hysteroscopy kits and fluid management packs.

  • obp is a privately held, global, medical device company focused on reinventing the everyday tools providers rely on by integrating LED lighting into single-use medical devices and commodity tools.
  • We serve more than 10,000 physician offices, surgery centers and hospitals in the US alone, plus other clinics and facilities, worldwide.

Contact us to learn how we illuminate every day with unified single-use device solutions that enable more straightforward, safer, and brighter outcomes. We’d love to help you move beyond the risks associated with ETO sterilization.
 

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