Why Consider X-Ray Sterilization?
Why Consider X-Ray Sterilization?

X-Ray Sterilization: Learn why X-ray irradiation is being considered as an alternative method to sterilize some polymer-based medical devices, such as wound care dressings, wearables, and ostomy appliances.

With evolving news headlines about COVID-19, the mention of supply-chain shortages in the medical industry brings to mind surgical masks, protective equipment, and virus test kits. Yet since this time last year, there also have been headlines about supply-chain risks of another kind—those related to temporary or permanent closures of ethylene oxide (EtO) sterilization facilities.

Several large EtO sterilization facilities in the United States have shuttered or temporarily halted operations due to environmental concerns about potentially dangerous air emissions. As a result, the U.S. FDA has been monitoring supply-chain interruption risks for devices that would typically be sterilized at those facilities. At the same time, medical device manufacturers and their extended supply chains have been prompted to reconsider their sterilization methods. According to FDA, more than 20 billion devices sold in the United States annually are sterilized with EtO, or about 50 percent of devices requiring sterilization.

Sterilization Basics

One of the last steps in the supply chain, sterilization usually takes place after a device has been manufactured and packaged, before it ships to a storage or end-use destination. The purpose of sterilization is to eliminate all living microorganisms on a device so that it is free from any contamination.

By killing all microorganisms, sterilization helps prevent any potentially harmful ones from reproducing and spreading infection when the device is used on a patient or in a healthcare setting. Most device makers outsource the sterilization process to large contractors with specialized equipment and facilities.

This article focuses on sterilization methods, including EtO, gamma irradiation, and X-ray, that are viable for use on devices containing plastic films, papers, and nonwoven materials, including medical-grade pressure-sensitive adhesives. Such materials are commonly found in disposable medical products, wound care dressings, ostomy appliances, surgical drapes, wearables, and patient monitoring devices.
Many polymer resin-based devices like these products cannot withstand hot-steam sterilization, a popular method without the risks of some other processes.  Read More..