Transitioning to e-beam or X-ray
The 6th Semi-Annual Medical Device Sterilization Conference takes place October 29-30 in Alexandria, VA. The event will join medical device sterilization professionals with other members of the industry for dynamic sessions and networking opportunities. Mark Murphy, Sr. Research Scientist at Pacific Northwest National Laboratory is one of the featured presenters at the program. Read on for more about Murphy’s background and what participants can expect from his session.
Can you please give a brief description of your background, job title and what that entails?
I have worked in the research scientist and group manager ranks at Pacific Northwest National Laboratory for over 30 years. I have expertise in a broad range of radiation dosimetry, radiation field metrology and experimental design for irradiation studies. This work includes characterization and use of passive dosimetry that involves a wide range of phosphor-based, radiachromic-based and photofluorescent-based dosimetry; as well as active dosimetry that involves real-time detection utilizing ionization chambers. This dosimetry and radiation metrology work has covered a wide range of applications, including nuclear worker protection, radiation effects on materials and electronics, medical therapy, radiation biology and high dose radiation processing (e.g., medical sterilization).
A project funded by the Office of Radiological Security (ORS) within the National Nuclear Security Administration (NNSA) comes in the wake of growing concerns related to cobalt-60 and ethylene oxide (EO) – both used for medical sterilization. This ORS project’s main objective is to perform radiation effects testing on five different medical devices (representing 17 polymers) in order to determine any effects differences between cobalt-60, electron beam (e-beam) and X-ray radiation. This “Team Nablo” project, named in memory of Sam Nablo, known by many in the radiation processing industry, is operated by Pacific Northwest National Laboratories (PNNL). This industry collaboration involving PNNL and eight industry players, represents a nascent shift in interest away from the dominant mode of radiation sterilization – cobalt-60 – giving industry device sterilization experts cause to wonder both about the future of gamma radiation and the competitiveness of its alternatives.
This presentation will weigh the alternatives to EO and cobalt-60, and the present status of the accelerator-based technologies – e-beam and X-ray. It will cover the pros and cons of various medical product designs for such polymer testing, how to optimize the test design and the main issues to expect. Lastly, it will cover the remaining data and education gaps, and describe the planned AAMI (American Association for Medical Instrumentation) guide to help device manufacturers navigate the transition to e-beam or X-ray.
What are some examples of EO & GAMMA alternatives you plan to cover?
Electron beam (e-beam) and X-ray.
What are 1-3 main takeaways you hope attendees will learn from the session?
- That medical device manufacturers, contract sterilizers, and governments entities can work together to move the single-use medical device industry forward.
- That there is an effort in progress that will provide device manufacturers a clearer picture on what it takes to navigate the transition to e-beam or X-ray.
- That there is an effort to make polymer effects data (from 3 radiation modalities) more available to the public.
Take part in this radiation masterclass and more engaging sessions at the Medical Device Sterilization Conference.