Factors Inhibiting the Introduction of New Technologies for Sterilization of Medical Devices

Electron beams have been used to sterilize medical devices since the 1950s. However, today the majority of irradiation sterilization providers use gamma rays from the decay of 60Co. Security concerns regarding the continued use of 60Co lead to a desire to increase the use of e-beams and x-rays. The latter are now a viable modality due to recent advances in accelerator technology. The choice of modality for medical device sterilization is a decision that impacts the entire manufacturing and delivery process of a medical device; one that can be very difficult to change once it has been made. Sterilization is an integral part of the validation of a medical device. For many products, a fragmented path of concept, design, manufacture, sterilization, marketing, and distribution are all handled by different people, departments, or companies. The international character of the industry further complicates introducing new elements to this chain. This paper documents the results of a study of the factors that inhibit the introduction of new technologies to complement and possibly replace 60Co sources for medical device sterilization. An implicit assumption at the outset of the study was that the regulatory burden of having to revalidate a device when changing the sterilization modality was a major impediment that prevented manufacturers from considering changes. Our study does not refute that assumption, but finds it to be a very complicated issue that is intricately entwined in technical, regulatory and market issues. Here we report our findings and conclude with a list of actionable recommendations.