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Sterilizer, Field, Special Materiel for Far Forward, Austere Environments


OBJECTIVE: Develop and validate a sterilization cabinet that can sterilize heat-sensitive surgical instruments and other materiel. DESCRIPTION: In the future, the Army will utilize multi-domain operations in order to fight and win against peer and near-peer adversaries. Armed conflict will likely occur via large-scale combat, resulting in high numbers of casualties in short periods of time where degraded air superiority and ease of maneuver will make evacuation extremely difficult. These circumstances will force units to hold casualties at earlier roles of care for longer periods of time, where lifesaving surgical interventions will need to take place in order to preserve life. This creates significant challenges to safely operating on casualties with sterile equipment. Sterilizers that utilize heat and steam exist at the Role 3 Field Hospital, with smaller sterilizers present at the Role 2-level Forward Resuscitative Surgical Detachment (FRSD). However, some specialized equipment (e.g. surgical scopes) cannot undergo heat/steam sterilization. High-level disinfection of these scopes is often not sufficient to mitigate the risk of infection in surgical patients due to crevices and hard-to-reach areas on the instrument. Even when traditional sterilization is possible, these methods often result in retained moisture that allows for bacterial growth. Unfortunately, many of these instruments include highly sensitive components that cannot be exposed to the high pressure, temperature, and moisture of heat/steam sterilization. Therefore, a sterilization method that sterilize the unique form factor of surgical scopes is needed. According to the Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities (2008), sterilization “destroys or eliminates all forms of microbial life, including bacterial spores” (page 9).1 The desired solution would provide a solution capable of sterilizing sensitive surgical scopes according to these CDC guidelines. While there may be some solutions in the marketplace, manufacturers of commercially-available products have not built to their systems for frequent transport and lack the rugged structure required for field use. PHASE I: The main goal of Phase I is to design a concept for a rugged benchtop sterilization cabinet. The physical design of the cabinet should put the centerline of the cabinet door no less than 48 inches from the floor and weigh no more than 182 pounds, with preference towards a lighter build. The internal compartment should be capable of holding two or more midsize sterilization baskets (17” x 11” x 4”) and large enough to house one or more standard-sized surgical scopes. The sterilization cabinet should operate by 110/20 VAC, 50/60 Hz power supply, and run times for optical equipment (i.e. surgical scopes) should last no longer than 75 1 minutes. The system display should be simple to navigate, allow for manual interruption of cycles, and the system should follow industry standards for data logging and recall of cycle data. Innovation is encouraged in each design aspect to create a lighter and more rugged cabinet. Required Phase I deliverables include a mock-up or early prototype of the desired sterilization cabinet. A report should also describe the cabinet design and features, the proposed sterilization process, progress made towards meeting the various parameters, and the results of any preliminary testing. PHASE II: The overall objective of Phase II is to produce a fully operational prototype sterilization cabinet that can sterilize sensitive surgical scopes based on the Phase I design. Phase II work can include building and testing of the prototype, iterative design improvements, manufacturing assessments, generating data necessary for regulatory submissions, building out multiple/additional sterilization cycles and testing them, and other related work. At the conclusion of Phase II, the performer should have achieved design lock of the system, developed a finalized prototype and be ready to move into more manufacturing-focused development. Required Phase II deliverables include a report describing the work accomplished under Phase II, with the latest design of the sterilization cabinet including specifications, a description of the final sterilization process for any/all cycles and options, a description of the user interface, and identification of all intellectual property and proprietary information. The ruggedization of the sterilization cabinet must also be addressed in the system design and performance documentation. Other deliverables include all regulatory submissions for the sterilization cabinet and subsequent communications with the Food and Drug Administration (FDA). Additional deliverables could include any manufacturing development that has been done. PHASE III DUAL USE APPLICATIONS: Building on the work completed under Phase II, a Phase III effort would complete any remaining work to test and validate performance of the sterilization cabinet, including its ability to withstand military rugged conditions. Phase III could also include completing work to successfully obtain regulatory clearance from the FDA, begin production prototyping and/or early manufacturing runs, and to bring the product to the commercial market. Based on the progress made in Phase II, the product would be considered as the solution to be fielded under the Sterilizer, Field, Special Materiel program managed by the Warfighter Expeditionary Medicine and Treatment Project Management Office. Phase III would include any remaining product development to progress the cabinet towards being ready for commercialization and fielding, such as packaging, manufacturing, regulatory clearances, and military testing. Beyond this, the U.S. Army would procure the finalized product in quantities sufficient to satisfy its fielding requirements. Other services would also be able to procure the finalized product for their capability needs as well. Units would then purchase resupply of this product to maintain this specific sterilization capability. In the civilian market, this solution is applicable to an ongoing problem in civilian healthcare facilities, as evidenced by the 2015 CDC “Call to Action” and the 2015 Joint Commission on high-level disinfection (see references). Despite the dates of these documents, this problem still persistents. If a sterilization cabinet that can fully and adequately sterilize these sensitive, hard-to-clean instruments becomes commercially available, it would greatly reduce the current burden on hospitals and outpatient clinics to sufficiently clean these instruments. As such, the commercial market for a technology of this nature would provide ample demand for the product. REFERENCES: 1. Association for the Advancement of Medical Instrumentation. ANSI/AAMI ST79:2017. (2017). Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA: AAMI. 2. CDC. (2015a). Immediate need for healthcare facilities to review procedures for cleaning, disinfecting, and sterilizing reusable medical devices. 3. The Joint Commission. (2015). High-‐level disinfection (HLD) and sterilization boosterpak. 4. 2015 CDC “Call to Action” to evaluate high-level disinfection across the nation. 5. TRADOC Pamphlet 525-3-1 “The U.S. Army in Multi-Domain Operations 2028”. 6 December 2018. 6. Emergency War Surgery, 5th Edition. Chapter 2 “Roles of Medical Care (United States)”. KEYWORDS: sterilization, surgical scopes, austere environment, surgery, field surgery, high-level disinfection, sensitive surgical equipment, secondary infection, infection prevention
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