Abstract
Access to sterilization is a critical need for global healthcare, as it is one of the prerequisites for safe surgical care. Lack of sterilization capability has driven up healthcare infection rates as well as limited access to healthcare, especially in low-resource environments. Sterilization technology has for the most part been static and none of the established sterilization methods has been so far successfully adapted for use in low-resource environments on a large scale. It is evident that healthcare facilities in low-resource settings require reliable, deployable, durable, affordable, easily operable sterilization equipment that can operate independently of scarce resources. Recently commercialized nitrogen dioxide (NO2) sterilization technology was analyzed and adapted into a form factor suitable for use in low-resource environments. Lab testing was conducted in microbiological testing facilities simulating low-resource environments and in accordance with the requirements of the international sterilization standard ANSI/AAMI/ISO 14937 to assess effectiveness of the device and process. The feasibility of a portable sterilizer based on nitrogen dioxide has been demonstrated, showing that sterilization of medical instruments can occur in a form factor suitable for use in low-resource environments. If developed and deployed, NO2 sterilization technology will have the twin benefits of reducing healthcare acquired infections and limiting a major constraint for access to surgical care on a global scale. Additional benefits are achieved in reducing costs and biohazard waste generated by current health care initiatives that rely primarily on disposable kits, increasing the effectiveness and outreach of these initiatives.
Highlights
Access to sterilization equipment is necessary to reduce disease transmission from instruments during surgical procedures
The NO2 sterilization process has been validated for the terminal sterilization of medical devices using typical sterilization chamber-based systems
For each hinge device and biological indicator (BI), the test tubes containing tryptic soy broth (TSB) and hinges or BIs were evaluated for growth after seven days
Summary
Access to sterilization equipment is necessary to reduce disease transmission from instruments during surgical procedures. There are unique advantages with the NO2 process that are not available with other sterilant gases These advantages include operation at room temperature, a relatively low sterilant concentration, rapid microbicidal activity, and minimal sterilant residuals on processed articles. These advantages permit the use of the NO2 process in low-resource environments. The concentration of NO2 used during a sterilization cycle is far below the NO2 dew point, and condensation of the sterilant will not occur This gaseous nature of NO2 at ambient conditions allows for efficient aeration of the load, making the processed articles safe to handle.[8]
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