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Innovative Solutions for Ethylene Oxide Mitigation Used in Sterilization Processes (Direct to Phase II)

Description:

OUSD (R&E) CRITICAL TECHNOLOGY AREA(S): Combat Casualty Care

 

OBJECTIVE: This topic is intended for technology proven ready to move directly into Phase II and is accepting Direct to Phase II proposals only. Develop innovative solutions that effectively mitigate ethylene oxide used as part of and generated during sterilization processes, promoting environmentally friendly and sustainable practices in the field of sterilization technologies.

 

DESCRIPTION: Approximately fifty percent of all sterile medical devices in the US are sterilized with ethylene oxide (ETO), which is highly effective at killing bacteria, viruses and other microorganisms (1,2). ETO is commonly used in the manufacturing of medical devices for its effective sterilization properties because it can sterilize heat - or moisture- sensitive medical equipment without harmful effects on the material used in the medical devices (1). The process involves exposing medical devices to ETO gas to eliminate microorganisms and to ensure product sterility. Medical devices are prepared for sterilization, loaded into a sealed sterilization chamber designed to maintain the appropriate conditions for the process, ETO gas is introduced into the chamber, penetrating the packaging, and reaching all surfaces of the medical devices and perturbing microbial DNA to prevent replication. After sterilization, the ETO gas is carefully removed from the chamber, and aeration processes may be employed to ensure residual ETO levels comply with safety standards. Once the sterilization process is complete, the medical devices remain unopened in order to maintain their sterility until use. It’s important to note that while ETO is effective for sterilization, its use has raised environmental and health concerns, particularly due to its potential carcinogenicity. ETO toxicity has been established in a variety of animals and exposure can cause a multitude of serious symptoms, including cancer, nerve damage and spontaneous abortion (4). This has led to ongoing efforts to develop alternative sterilization methods with reduced environmental impact and health risks. Currently, there are no or limited commercially available products that can mitigate the ETO byproducts of medical device manufacturing. Current methods generate various byproducts, posing environmental concerns and potential cancer risks associated with exposure. The desired novel materiel solution should be compatible with current ETO sterilization equipment and focus on minimizing or eliminating ethylene oxide emissions during medical device sterilization. We are specifically seeking advancements in sterilization technologies that prioritize environmental sustainability and health, aiming to exclude methods that expose humans and the environment to residual ETO. The military’s substantial investment in 3D printing and additive manufacturing reflects a strategic shift towards agile and on-demand production capabilities. However, the use of certain materials in these processes necessitates a crucial consideration: the need for safe ETO sterilization. As military applications often involve the production of critical components, ensuring the sterility of these items is paramount. ETO sterilization is particularly relevant in preserving the integrity of materials susceptible to heat or moisture damage during traditional sterilization methods. This dual focus on advanced manufacturing and sterilization underscores the military’s commitment to not only innovation but also the quality and reliability of the products generated through these cutting-edge technologies. There is a plan for modernizing medical sterilization in an austere environment, and the DOD maintains an active technology watch program on emerging technologies in sterilization to enhance other surgical capabilities, including ETO sterilization.

The technology is not limited to but may consider the factors below:

1. The technology must consider a plan for FDA clearance and EPA review.

2. Technology should be capable of integrating into or compatible with current medical device manufacturing and sterilization processes without necessitating significant alterations to the existing sterilization processes and setup.

3. Technology should be capable of operating continuously and should not become the rate-limiting step to current standard manufacturing processes.

4. Engineering solutions overall should require minimum logistical support.

5. Technology should be operable with little training or background with unambiguous primary output. Technologies that seek to use methods other than ETO sterilization are not the primary focus of this topic. To be clear, we are seeking strategies or technologies to reduce ETO emissions to as close to zero as possible from the ETO sterilization process. We are NOT seeking alternatives to ETO sterilization under this sterilization.

 

PHASE I: This topic is intended for technology proven ready to move directly into Phase II. Therefore, the offeror shall provide detail and documentations which demonstrates the accomplishment of a “Phase I-like” effort, including a feasibility study. This includes, insofar as possible, the scientific and technical merit of a prototype that will provide a novel ethylene oxide (ETO) mitigating solution for medical device sterilization that can be easily integrated into current medical device manufacturing processes. The solution should address cancer risks associated with ETO exposure without necessitating large modifications to current manufacturing processes and setups. Feasibility documentation of particular interest is prior evidence leading to:

• Evidence that the proposed solution will be viable with adequate risk mitigation.

• Design considerations to include sensors and other necessary instrumentation to detect, measure and warn of the presence of ETO or any other toxic byproduct of the sterilization process.

• Identification and analysis of potential challenges and risks associated with the implementation of the proposed solution.

 

Proposers should consider the additional challenges associated with testing potential solutions. Considerations may include working closely with a safety officer, use of a negative pressure chemical hood (lowered stash for safety and to increase the negative flow rate), evacuation of the test site area/building and other safety mitigation strategies as needed.

 

These deliverables collectively demonstrate the technical viability, feasibility, and strategic planning necessary for the successful development of the ethylene oxide byproduct mitigation solution.

 

PHASE II: The Phase II focus is on comprehensive development and refinement of the ETO byproduct mitigation solution for medical device sterilization.

Key expectations include:

1. Prototype development

• Develop a demonstration prototype to thoroughly examine various design approaches and refine them for the best outcomes. It's crucial to ensure that the prototype is compatible with a wide range of currently approved ETO sterilizers, catering to different types and models. Assumptions should be made based on the largest market elements to align with potential user needs and preferences.

2. Efficacy testing

• Rigorous testing and validation of the solution’s efficacy in mitigating ETO byproducts, with a particular emphasis on addressing health and environmental risks. Testing shows the equipment’s ability to reduce ETO emissions from sterilization process to as close to zero as possible, surpassing current FDA/EPA standards. Device should not interfere with components already in use for sterility assurance level (SAL) that is the FDA standard for confirming the absence of microbes.

3. Regulatory Compliance

• Develop a regulatory plan with relevant regulatory standards and requirements for medical device sterilization (2) to include current EPA standards (6).

4. Scale up strategy or commercialization plan.

• Development of a scalable strategy for integrating the solution into diverse manufacturing processes without compromising efficiency Phase II expectations revolve around advancing from proof-of-concept to a more mature and market-ready product, positioning the project for successful commercialization and broader impact in the medical device manufacturing industry.

 

PHASE III DUAL USE APPLICATIONS: Following the successful Phase II development, this ETO mitigation prototype may be poised to revolutionize sterilization practices across numerous sectors. According to the FDA, approximately 20 billion medical devices are sterilized each year using ETO, and for most of these devices, ETO is the only validated and viable sterilization method. That said, this product is expected to have customers in a full range of industries, and in fact medical sterilization only accounts for about 1% of all industrial uses of ETO. With its ability to enhance safety and reduce risks associated with ETO sterilization, this technology offers a versatile solution for industries reliant on ETO sterilization, including medical, pharmaceutical, food, laboratory, veterinary, cosmetic, and textile sectors. The primary objective beyond Phase III is to transition the ETO mitigation prototype from development to widespread implementation across diverse industries, to include the medical device industry. Plan may include exploring potential collaborations and partnerships with industry stakeholders, regulatory bodies, or research institutions. An effective commercialization plan provides evidence of following a comprehensive strategy outlining how the ETO mitigation solution will be brought to market. The small business should have plans to secure funding from non-SBIR government sources and/or the private sector to develop or transition the prototypes into a viable product for sale to the military and/or commercial markets. The positive impact of successfully implementing the ETO mitigation solution extends beyond industry standards, fostering a paradigm shift toward environmentally conscious and health-focused practices, ultimately contributing to a safer and more sustainable future for medical device manufacturing.

 

REFERENCES:

  1. CDC. (2019). Ethylene Oxide Sterilization. Centers for Disease Control and Prevention. https://www.cdc.gov/infectioncontrol/guidelines/disinfection/sterilization/ethylene-oxide.html
  2. Health, C. for D. and R. (2022). Sterilization for Medical Devices. FDA. https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices#ethylene
  3. International Organization for Standardization. (2014) ISO 11135:2014, Sterilization of Health Care Products – ethylene oxide – Requirements for the development, validation, and routine control of a sterilization process for medical devices.
  4. OSHA. (2019). Home | Occupational Safety and Health Administration. Osha.gov. https://www.osha.gov
  5. Executive Order 13329. (2010). NIST. https://www.nist.gov/tpo/executive-order-13329
  6. US EPA, O. (2018, August 13). Hazardous Air Pollutants: Ethylene Oxide. US EPA. https://www.epa.gov/hazardous-air-pollutants-ethylene-oxide

 

KEYWORDS: Manufacturing-related, Ethylene Oxide, Byproducts, Sterilization, Mitigation, Environmental sustainability, Sterilization techniques, Green sterilization, Ethylene Oxide Emissions, Manufacturing processes, Sterilization equipment, Industrial production, Sustainable manufacturing, Ethylene Oxide treatment, Manufacturing practices

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