#United States #Arlington #sterilization #Boulder iQ #Jim Kasic

Boulder iQ CEO Delivers Keynote on Medical Device Sterilization

Jim Kasic, the president and CEO of Boulder iQ, will serve as the keynote speaker at the upcoming Medical Device Sterilization Conference in Arlington, Virginia, scheduled for May 6, 2025. His presentation, titled "Evaluation of Ethylene Oxide Sterilization Going Forward in Light of New EPA Regulations," will provide comprehensive insights into the evolving landscape of medical device sterilization amidst tightening environmental regulations by the U.S. Environmental Protection Agency (EPA).

As healthcare and medical device manufacturers grapple with stringent new rules related to ethylene oxide (EO) sterilization, Kasic’s presentation comes at a crucial time. The EPA has enacted what are considered the most rigorous measures to date for EO commercial sterilization facilities, significantly influencing the operations of medical device contract sterilization providers. Kasic’s talk aims to offer an economic analysis of the costs associated with compliance to these requirements, operational strategies for meeting the new restrictions, and methods to prevent delays in product availability as sterilization facilities adapt to these changes.

Addressing Industry Concerns

Kasic will highlight the importance of maintaining supply chain efficiency during the transition to upgraded sterilization protocols. "Medical device developers who are accustomed to using EO are understandably worried about how these changes will affect costs and availability moving forward," states Kasic. "While the EPA is not banning EO sterilization outright, they are making strides to limit EO exposure due to its emissions and environmental impact, making it imperative for businesses to consider alternatives."

In addition to discussing EO sterilization, Kasic will delve into chlorine dioxide (CD) as an environmentally friendly sterilization alternative. CD has been recognized for its effectiveness and cleanliness, showcasing a long and successful history as a sterilization method. Kasic believes that incorporating CD into sterilization practices could reduce reliance on EO without sacrificing efficiency and effectiveness in maintaining product safety.

With the conference's 2025 focus on ensuring the sterility and availability of medical devices while adhering to EPA regulations, Kasic's insights will be particularly pertinent. He is expected to touch upon how the industry can monitor growth in capacity while also ensuring compatibility between different sterilization methodologies, particularly radiation techniques.

Boulder iQ's Role in the Industry

Boulder iQ, based in Boulder, Colorado, positions itself as a pivotal player in supporting life sciences companies. The firm provides comprehensive services necessary for bringing medical products to market, with a strong emphasis on regulatory compliance and quality assurance. Boulder Sterilization, a sister company, specializes in both EO and CD sterilization services tailored for medical devices and in-vitro diagnostic products. Together with Boulder Regulatory Affairs and Quality Assurance, they provide multifaceted support that expedites the product development process.

The company, certified under ISO 13485:2016, emphasizes its commitment to quality and compliance in the life sciences sector, reinforcing its position as a trusted partner for medical device developers.

Conclusion

As Kasic prepares to deliver his critical insights at the Medical Device Sterilization Conference, attendees can expect to gain valuable understanding of both the challenges and opportunities that lie ahead under the new regulations. The conference will serve as a prime opportunity for industry stakeholders to engage in discussions on adapting to regulatory changes while simultaneously ensuring the availability of safe and effective medical devices for consumers. Through collaboration and open dialogue, the industry can navigate these complexities as it aims to achieve the best outcomes for public health and safety.