Rationale
Reuse of needles is prevalent in developing countries. In 14 low-income countries, at least 50% of injections given were considered unsafe due to lack of sterilization before reuse.1 Furthermore, trained personnel and spare parts for available sterilization machines are not readily available in such environments. These issues prompt an immense need for a system which sterilizes syringes in a safe and easy-to-use manner. This invention should enable clinicians in developing countries – with minimal training – to reduce the bacterial presence on syringes and other small medical instruments to safe levels.
The PASS is designed to be used by individuals in the medical field in developing countries. Due to the overall lack of formal medical training in such areas, the device should possess a graphic user interface (GUI) which is intuitive and user-friendly, removing the need for extensive formal training.2 By further employing the use of renewable energy sources in the absence of a reliable, steady source, the device’s versatility and portability will augment greatly. When combined, these factors will promote the use of this sterility system, encouraging medical providers to clean and sterilize syringes and other small surgical instruments before each reuse, thereby mitigating the infection rates in relevant areas.
Design Objectives
The PASS has number overall objectives and goals with regards to its design, although some specificities still remain nebulous. First and foremost, the device must sterilize medical equipment to a safe sterility assurance level (SAL ≤ 10-6). The SAL quantifies the amount of bacterial burden a piece of medical equipment has before it is considered to be truly “sterile.” The figure 10-6, a standard set by the FDA and WHO, signifies that there is a 1 in a 1,000,000 probability of finding a non-sterile unit on the medical instrument after sterilization. This figure allows for statistical quantification of sterility efficacy.
Next, the device must be lightweight to enable portability and ease of transport between locations. Developing countries (African nations, for example), do not typically have a centralized system of medical care, implying a need for transportable equipment.3
Furthermore, the device must be operable with limited technical skills of the user. As previously explained, because administration of injections in low-income countries may be performed by untrained individuals, it is vital to make the sterility system as user-friendly and intuitive as possible.1 This will encourage widespread use, while minimizing user-error during operation.
The PASS, again, must be powered by alternative and renewable energy sources in an effort to diminish the need for stable electricity outlets. Although the design itself is unclear, solar power and mechanical power are two options in the forefront of the team’s planning.
Finally, the PASS must securely contain the sterilant while sterilizing small surgical instruments in a timely manner. Because both liquid and vaporized PAA is toxic to biological materials, the PASS must disallow either from escaping, preventing user-harm. Using a renewable energy source should not compromise the duration of the sterilization process itself by elongating it to unreasonable lengths. Precise times cannot yet be determined, however, due to present uncertainties in design.