Gamma, electron beam and X-ray irradiation effects on polymers in an advanced bone cement mixer device

The medical device industry has been investigating ways to increase the use of alternatives to cobalt-60 gamma radiation and ethylene-oxide gas sterilization, such as electron beam (E-beam) and X-ray radiation, due to regulatory and market pressures. One impediment to switching to E-beam or X-ray te...

Full description

Saved in:
Bibliographic Details
Published in:Radiation physics and chemistry (Oxford, England : 1993) England : 1993), 2024-09, Vol.226 (N/A)
Main Authors: Li, Donghui, Bisel, Tucker T., Cooley, Scott K., Ni, Yelin, Murphy, Mark K., Spencer, Mychal P., Hasan, Md Kamrul K., Fifield, Leonard S., Pharr, Matt, Staack, David, Huang, Min, Pillai, Suresh D., Nichols, Larry, Parker, Rod, Gustin, Erick
Format: Article
Language:English
Subjects:
electron beam
gamma
medical device
polymers
radiation effects
sterilization
Team Nablo
X-ray
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:The medical device industry has been investigating ways to increase the use of alternatives to cobalt-60 gamma radiation and ethylene-oxide gas sterilization, such as electron beam (E-beam) and X-ray radiation, due to regulatory and market pressures. One impediment to switching to E-beam or X-ray technology for sterilization is the lack of data on the effects of these radiation sources on medical device polymers. To provide such data this work considers irradiation and testing of a common single-use medical bone cement mixing system, the Stryker Advanced Cement Mixer (ACM®), that is composed of seven polymer materials. The ACM® devices considered here were processed to sterilization-relevant doses (15, 25, 50, and 70 kGy) using three radiation technologies: gamma, E-beam, and X-ray. The system and its polymer components were tested for product functionality, as well as mechanical and visual properties to determine how exposure effects may be influenced by radiation technology and dose level. We found that although there were instances of statistically significant differences in effects between the gamma-irradiated products and those irradiated with E-beam and X-ray, those effects were negligible in terms of retained functionality of the product and retained mechanical properties of the polymer components. Overall, results of this study demonstrate that, for of the effects studied, E-beam and X-ray are viable alternatives to cobalt-60 gamma radiation for sterilization of the polymer-based device investigated.
ISSN:0969-806X