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Chemical Sterilant for Far Forward, Austere Environments


OBJECTIVE: Develop and validate a chemical sterilant solution that can sterilize surgical instruments and other materiel through immersion. Product could be a powder or concentrated liquid that when mixed with potable water, creates the requisite solution capable of the desired sterilization. DESCRIPTION: In the future, the Armed Forces 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 over short time periods 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. For example, the Army sterilizers that exist at the Role 3 Field Hospital, with smaller sterilizers present with the Forward Resuscitative Surgical Detachments at some Role 2s. However, heat/steam sterilization cycles can take close to an hour to complete and some items (e.g. retractors) can’t fit into the sterilizers that are present at the Role 2. The inability to adequately sterilize some of these items is an issue in and of itself, but the mass casualty situations that will be prevalent during large-scale combat operations will compound this issue. In addition, medical units likely won’t be able to sterilize surgical equipment quickly enough to meet surgical demand, and/or surgery will need to take place in settings without the space and infrastructure to support heat and steam sterilizers. As such, the desired chemical sterilant solution would not only address shortcomings at the Role 2, but it would also augment existing sterilization capabilities to help mitigate bottlenecks during mass casualty situations. 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” (page 9)1. This capability is looking for a chemical solution that is capable of sterilization according to these CDC guidelines. Because of the unique circumstances of performing surgery in austere conditions, the solution would need to have additional attributes beyond its ability to sufficiently sterilize surgical equipment. The solution would need to effectively sterilize instruments in 10 minutes or less (perhaps through immersion) at ambient temperatures (i.e. wouldn’t require being warmed or cooled to be effective), and once activated (e.g. when a powder is mixed with water to create a sterilization liquid), should remain effective for at least 36 hours. The solution also needs to be safe enough to not require disposal as a hazardous chemical nor cause irritation if it comes into contact with bare skin. Additionally, because military logistics entail products being shipped in non-climate-controlled containers, the 1 product will need to be stable enough to withstand extreme temperatures (high and low) and a variety of humidity conditions without impacting its performance. PHASE I: The Phase I effort should focus on designing and/or developing an innovative solution that could sterilize surgical equipment as described above. Testing of the solution should demonstrate its ability to sterilize per the CDC Guidelines. Additional testing/assessments should demonstrate the proposed solution’s ability to adhere (or potential to adhere) to sterilization time and shelf stability once activated. Disposal considerations should also be assessed, as the product will need to eventually comply with Environmental Protection Agency (EPA) regulations as well as FDA regulations before being fielded. The product cannot be considered hazardous material, and should be safe enough to dispose of down a drain and ideally, safe to dispose of on the ground. Additionally, the product should not cause irritation if it comes into contact with bare skin. The concept of use in the field should also be developed, outlining the process to activate, use and dispose of the product. This should attempt to be as comprehensive as possible, e.g. how the product will be shipped and stored (e.g. environmental conditions, acceptable containers), including after activation, through to disposal. Safety precautions that personnel will have to take with the product (before, during, and after use) should also be addressed. Required Phase I deliverables will include the results of all testing and assessments done on the product to support its ability to meet the parameters outlined in the Details section, along with a demonstration of how the product is used (can be a video). Additional key information about the product should be summarized in a report. The report should also address the solutions’ ability or potential to meet all of the parameters. PHASE II: Using the results from Phase I, further develop, demonstrate and validate the solution identified and tested in Phase I. The performer should produce enough material to fully validate whether the solution can meet the CDC Guidelines for sterilization of surgical equipment, as well as begin to validate the solution’s ability to meet the other parameters. Through this testing and validation process, the performer should make iterative refinements to the proposed solution to enable it to meet all of the parameters. The Phase II effort should also include verification of how well the solution can be integrated into the intended field environment. The Phase II effort could include finalizing the proposed solution, as well as conducting environmental studies and preclinical or clinical studies to support regulatory submissions to the Environmental Protection Agency and Food and Drug Administration (respectively). Stability and shelf life studies could also be included during Phase II. Additional testing on the product to evaluate its compatibility with the intended fielding environment could also be included. This may entail demonstrating how the product can be utilized in different scenarios given the materials available at the Role 2 aid station and Role 3 field hospital. These demonstrations could also include user testing. Required Phase II deliverables will include results that demonstrate all the parameters that the solution can meet, along with any data/information that support its potential to meet any parameters that aren’t already met. Demonstrations of how the proposed solution can be integrated into the Role 2 and 3 environment (video submission is acceptable) and/or results of user testing could also be a Phase II deliverable. Additional required deliverables would be any regulatory submissions and communications with the EPA and FDA. The status of the effort and all deliverables should be captured in a report that captures the detailed outcomes of the work completed during Phase II, the status of regulatory submissions, and the degree to which the proposed solution(s) meets the additional performance parameters. PHASE III DUAL USE APPLICATIONS: Using the results and progress made during Phase II, a Phase III effort would complete any remaining work necessary to have the proposed solution meet the performance parameters described in this topic, obtain regulatory clearance from both the EPA and FDA, establish appropriate stability and shelf life of the product, demonstrate its performance in a military-relevant environment, become production ready, and become commercially available. Based on the progress made in Phase II, the product would be considered as the solution to be fielded under the Chemical Sterilant program managed by the Warfighter Expeditionary Medicine and Treatment Project Management Office (WEMT PMO). Phase III would include any remaining product development to progress it 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 may provide a new, innovative option for rural clinics to sterilize critical tools and instruments (e.g. forceps, scalpels, scalpel handles) where they don’t have the capacity for large sterilization equipment, but would also work well for emergency response situations where field hospitals are set up by the American Red Cross, the Federal Emergency Management Agency, or other non-profits. Additionally, international development and non-profit organizations focused on improving healthcare in resource-poor settings outside of the U.S. may also find this product a useful way to push a sterilization capability into areas where surgery is difficult or dangerous, such as isolated village clinics in under-developed countries. 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. Centers for Disease Control and Infection. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 (updated May 2019). 3. TRADOC Pamphlet 525-3-1 “The U.S. Army in Multi-Domain Operations 2028”. 6 December 2018. 4. Emergency War Surgery, 5th Edition. Chapter 2 “Roles of Medical Care (United States)”. KEYWORDS: chemical sterilant, sterilant, sterilization, surgery, surgical instruments, austere environment, mass casualty event, field surgery, secondary infection, infection prevention
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