In this Phase I SBIR, KWJ Engineering Inc. proposes to combine our years of experience with ozone generation and sensing technology with the NIH SBIR program to develop novel technology for the sterilization of medical instruments and sharps. The proposed technology is significant since the instrument will serve as a miniature, low power and low cost platform capable of decontamination of viral pathogens such as HIV, Hepatitis B and Hepatitis C (HBV, HCV). The technology will be closely aligned with the NCHHSTP vision of """"""""Development of appropriate and affordable technologies that may contribute to solving the problems of unsafe injection and unsafe sharps disposal"""""""". In particular, the sterilizer instrument will serve to fulfill NCHHSTP objectives related to """"""""...Examples of such technologies -- not to the exclusion of others, which may be materials, methods, techniques, instruments, or devices - include: a) plastic needles to replace steel ones to simplify sharps disposal;b) noncorrosive sterilants without the disadvantages of bleach, or other equipment for effective sterilization of reusable medical instruments"""""""". The sterilizer will incorporate a KWJ designed MEMS (Micro-Electromechanical Systems) based micro-plasma generator for the production of ozone in a compact and low-power design. The proposed design will incorporate a sterilization chamber with ozone sensors (KWJ designed) and process controller to monitor cycle time and ozone concentration prior to ambient exposure after the sterilization cycle. The proposed device will be a marked improvement over technologies that are commercially available due to the ease of ozone generation from atmospheric air and its subsequent degradation to oxygen with no generation of residual by- products or hazardous species. Medical sterilizers available on the market today are primarily steam-based, with ethylene oxide and hydrogen peroxide plasma as other alternatives. Steam-based autoclaves, while effective, are energy intensive, while ethylene oxide is a toxic gas and can leave behind residuals. These sterilization methods, while adaptable for hospitals, cannot be used as portable sterilization solutions for field operations. In addition, other chemical alternatives require replenishing of reagents and regular maintenance. The proposed device will be portable, light-weight, with relatively low power consumption and low cost, requiring virtually no maintenance and will be deployable for mobile applications such as disaster relief and military combat scenarios where rapid and on-site sterilization is required for field surgical procedures. The simplicity and versatility of the system also provide a means to implement safe sharps-related recycling and disposal protocols using ozone as the primary disinfectant, thereby addressing a critical area of concern regarding transmission of diseases through percutaneous sharps injuries as related to public health and safety.

Public Health Relevance

The proposed ozone sterilizer can provide an efficient and effective means to decontaminate medical instruments and sharps with the use of ozone, a highly reactive and broad-spectrum disinfectant. The use of micro-plasma technology to create ozone leads to a compact, low-cost and portable device that can fulfill the need for an effective and versatile methodology for sterilizing re-usable medical instruments as well as for sharps disposal. The resulting device will greatly increase safety and reduce risk when working in environments that pose danger of exposure to HIV/AIDS, Hepatitis and other infectious diseases, and can serve as a crucial tool for medical practitioners in situations where access to regular medical care is limited, while being easily adaptable for medical waste and recycling systems, with the capability of rapidly neutralizing myriad viral, microbicidal and sporicidal agents, with a low resource footprint.

National Institute of Health (NIH)
National Institute of General Medical Sciences (NIGMS)
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
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Special Emphasis Panel (ZRG1-AARR-E (11))
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Cole, Alison E
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Kwj Engineering, Inc.
United States
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