Skull_Fracture_RFI_Final.docx

Skull Fracture Blast Injury Prevention Standards Request for Information

This Request for Information (RFI) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the U.S. Army Medical Research and Development Command (USAMRDC), headquartered at Fort Detrick, Maryland. The USAMRDC mission is to provide medical knowledge and materiel lifecycle management to protect, treat, and optimize Warfighter health and performance across the full spectrum of operations.

The Department of Defense (DoD) Blast Injury Research Coordinating Office (BIRCO) coordinates DoD blast injury research investments, on behalf of the Executive Agent (EA), to ensure critical knowledge gaps are filled, avoid costly and unnecessary duplication of effort, and accelerate the fielding of prevention and treatment strategies by leveraging existing knowledge and fostering collaboration and information sharing among the world's blast injury experts. The BIRCO advises the EA, Commanding General (CG), USAMRDC, on Military Health System (MHS) Blast Injury Prevention and Treatment Standards to recommend to the Office of the Assistant Secretary of Defense for Health Affairs [OASD(HA)]. To identify the best available standards that will meet the needs of the DoD, the BIRCO, in collaboration The MITRE Corporation, employs the MHS Blast Injury Prevention Standards Recommendation (BIPSR) Process. The BIPSR Process is designed to address the needs of all Services for biomedically valid MHS Blast Injury Prevention Standards to protect against the entire spectrum of blast injuries. The process provides an unbiased, stakeholder-driven critical assessment methodology for identifying the best biomedically valid candidate MHS Blast Injury Prevention Standards currently available. It supports the development and testing of safe weapons and effective combat platform crew and individual protection systems. It is important to note that the BIPSR Process is not a research program and does not develop new injury criteria or injury prediction tools. However, it does inform research by identifying gaps where no suitable standards currently exist.

The term “MHS Blast Injury Prevention Standard” is defined as a “biomedically valid description of physiologically or biomechanically based injury and performance responses of a human to blast insults.” The standards can range from simple dose response curves and injury thresholds that address single components of blast insults, such as peak force, to complex algorithms and computational models that address multiple components of blast insults, such as force-time history. These standards will play a critical role in the prevention of Warfighter injuries and the enhancement of Warfighter survivability by informing health hazard assessments, survivability assessments, and protection system development aimed at producing safe weapon systems, survivable combat platforms, and effective protection systems. To conduct these assessments, the DoD needs MHS Blast Injury Prevention Standards to investigate the physiological and biomechanical effects of blast injuries on the Warfighter, such as when generated by enemy explosive weapons and when produced by blast exposures during weapon systems firing.

For the purposes of this RFI, Blast Injury is defined as an injury that occurs as the result of the detonation of high explosives, including vehicle-borne and person-borne explosive devices, rocket-propelled grenades, and improvised explosive devices. The taxonomy of injuries from blast explosive devices is comprised of: (a) Primary: Blast overpressure injury resulting in direct tissue damage from the shock wave coupling into the body; (b) Secondary: Injury produced by primary fragments originating from the exploding device (preformed and natural (unformed) casing fragments, and other projectiles deliberately introduced into the device to enhance the fragment threat); and secondary fragments, which are projectiles from the environment (debris, vehicular metal, etc.); (c) Tertiary: Displacement of the body or part of the body by the blast overpressure causing acceleration/deceleration to the body or its parts, which may subsequently strike hard objects and suffer typical blunt injury (translational injury), avulsion (separation) of limbs, stripping of soft tissues, skin speckling with explosive product residue, and building structural collapse that results in crush and blunt injuries or crush syndrome development; (d) Quaternary: Other ‘explosive products‘ effects - heat (radiant and convective) and toxic (toxidromes from fuel, metals, etc.) - causing burn and inhalation injury; (e) Quinary: Clinical consequences of ‘post-detonation environmental contaminants‘ including bacteria (deliberate and commensal, with or without sepsis), radiation (dirty bombs), tissue reactions to fuel, metals, etc. BIPSR Process Stakeholders have identified 14 BIPSR Process Blast Injury Types: Lower Extremity, Spine/Back, Upper Extremity, Skull Fracture, Moderate to Severe Traumatic Brain Injury (TBI), Pelvic/Urogenital, Neck, Face, Abdomen, Thorax, Skull Fracture, Ocular, Auditory, and Mild TBI.

The BIPSR Process is currently focused on human Skull Fracture Blast Injury Prevention Standards. Blast-related skull fracture injury includes blunt, behind helmet blunt trauma, ballistic, and combined effects of blunt and ballistic threats. Potential operational environments and intended uses of human Skull Fracture Blast Injury Prevention Standards may include the protection of military service members who are exposed to blunt impacts resulting from acceleration of the body, blunt injury from a ballistic strike to the helmet, or to penetrating and/or blunt injuries resulting from the propulsion of fragments and debris into the head, from strong blast winds and pressure gradients produced by an explosion. The BIPSR Process identified a need to define injury criteria and test methods to establish thresholds for protective systems designed to protect against skull fracture.

This RFI seeks to:

(1) Obtain information on existing skull fracture blast injury criteria, thresholds, standards, and models, etc., that could be considered as potential DoD standards, as well as those being developed or researched that could inform the BIPSR Process.

(2) Identify gaps between existing knowledge and that knowledge needed to inform standards.

(3) Give performers/producers of existing protection systems that are highly relevant to understanding human tolerance limits and predicting injuries sustained by blast victims an opportunity to describe how they can assist in standards identification, development, and research.

(4) Identify researchers who have developed, or are developing or researching, blast injury criteria, thresholds, and testing methods, and that possess appropriate scientific expertise, experience, and resources to describe and provide the scientific evidence needed to inform the standards.

(5) Identify and obtain methodologies, tools, models and simulations, dose-response curves, injury thresholds, computational models, their components and parameters, and associated technologies that may contribute to an upgradable platform for continuous integration of improved technologies.

(6) Obtain information from a broad community, including industry, academia, and other federal agencies on the availability of military-relevant blast injury standards.

To submit copies of publications, articles, reports, images, etc., related to existing or emerging human skull fracture blast injury criteria, thresholds, and models, etc., for consideration as potential DoD Military Health System Blast Injury Prevention Standards, please visit the DoD Blast Injury Research Coordinating Office website at https://blastinjuryresearch.health.mil/. You will be asked to provide basic contact information and will then be provided a username, password, and a link to the RFI submission site. After submitting your document(s), you will receive confirmation that your document was successfully submitted.

DISCLAIMERS AND IMPORTANT NOTES

This RFI is issued solely for information and program planning purposes; it does not constitute a formal solicitation for proposals. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Submission is voluntary and is not required to respond to a subsequent Broad Agency Announcement (BAA) (if any) or other research solicitation (if any) on this topic.

The USAMRDC/U.S. Army Medical Research Acquisition Activity (USAMRAA)/DoD BIRCO will not provide reimbursement for costs incurred in responding to this RFI. Respondents are advised that USAMRAA/USAMRDC/DoD BIRCO are under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted under this RFI. Information in responses will be held confidential to the extent permitted under applicable laws and regulations. Any proprietary, non-public information should be marked so.

Questions should be addressed to the Contract Specialist for this RFI, Skylar Wells at skylar.a.wells2.civ@health.mil.