Abstract
Half of single-use medical devices are sterilized using irradiation. Probably more than 80% of the industrial irradiation capacity is dedicated to sterilization of disposable or single-use medical devices. There are three main industrial irradiation technologies: gamma (based on 60Cobalt radioactive sources) which counts for about 80% of radiation capacity installed worldwide; electron beam which counts for about 20% of the total radiation capacity installed; and X-ray which has started to gain a foothold in the irradiation market. The adoption of alternative technologies is of highest importance to many medical device manufacturers due to the fact that the 60Cobalt sources in the world are ending and thus the price for the gamma sterilization services is increasing. Alternate sterilization method is X-Ray which is comparable to gamma. High-energy X-rays are similar to gamma rays. Radiation sterilization by X-rays is another option for sterilization of medical devices and other products.
Highlights
Historical background and development of irradiation over the yearsIonizing radiation used in medical device irradiation includes gamma (γ)-rays, X-rays, and electron beams (e-beams)
Increasing regulatory demands governing 60Co use, supply chain costs, the time needed for γ-rays sterilization, and the inability to use γ-rays for sterilization during product manufacturing, are key aspects triggering the switch to e-beam or X-ray radiation alternatives for some medical devices
There are obstacles that make it difficult for manufacturers of medical devices to navigate this transition. One of these hurdles was highlighted in the Fermilab report in 2017, which concludes that: “...there is a knowledge gap in how the different radiation sources (60Co, e-beam and X-ray irradiation) affect common medical device materials
Summary
Ionizing radiation used in medical device irradiation includes gamma (γ)-rays, X-rays, and electron beams (e-beams). Approximately 40 to 50% of disposable medical products manufactured are sterilized using ionizing radiation, which includes gamma, X-ray and e-beam [3]. Products sterilization by irradiation is an internationally recognized and widely used technology for the processing of medical devices, pharmaceuticals, tissues, and biological substances as well as disposable laboratory equipment.
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