TECHNOLOGY AREA(S): Biomedical

ACQUISITION PROGRAM: Forward Resuscitative Surgical System (FRSS) � AMAL 645.

OBJECTIVE: Develop a field-ruggedized medical device for providing field sterilization of surgical instruments, tools, trays, and other reusable medical devices that come into contact with patients.

DESCRIPTION: Sterilization of medical and surgical tools is a critical step in minimizing the risk of infection to combat casualties during far-forward medical interventions. Current field sterilizers are large, power-intensive systems that require large amounts of clean water to operate and present a logistical burden to forward-deployed resuscitative surgical facilities. There is a need for a low-cost, person-transportable medical sterilizer capable of sterilizing small surgical tools and trays in a Role 1-2 tactical environment. The system internal chamber volume must be capable of holding one standard USN perforated sterilizing container (23 x 12 x 7 inches, NSN 6530-01-500-9583). The system must be hand-transportable by no more than two persons per MIL-STD-1472 (Threshold (T)), one person (Objective (O)), and must have no single exterior dimension greater than 40 inches. The system must consume no more than 800 Watts of electrical power (T), 500 Watts (O); must consume no more than 5 liters of water per use (T), 0 liters of water per use (O); and must be capable of prolonged use in all Marine Corps operational environments and meet all Marine Corps transportation and storage requirements per MIL-STD-810G. The system shall comply with all Human Factors Engineering requirements per MIL-STD-1472, including noise requirements per indoor use, operations using gloves or MOPP gear, and comply with all safety factors therein. The system must operate using 120 VAC 60 Hz/210 VAC 50 Hz single phase power (T), be capable of operating for up to 2 hours on 24 VDC hot-swappable rechargeable battery power (O). The system must be capable of performing at a minimum 18 sterilizations within a 48 hour period (T) to meet FRSS surgical requirements. The system must achieve U.S. Food and Drug Administration (FDA) 510(k) certification prior to fielding.

PHASE I: Develop concepts for a PREEMS device that meets the requirements described above. Demonstrate the feasibility of the concepts in meeting Marine Corps needs and establish that the concepts can be developed into a useful product for the Marine Corps. Establish feasibility by material testing and analytical modeling, as appropriate. Provide a Phase II development plan with performance goals and key technical milestones, and that will address technical risk reduction.

PHASE II: Develop a prototype for evaluation. The prototype will be evaluated to determine its capability in meeting the performance goals defined in the Phase II development plan and the Marine Corps requirements for the PREEMS device per the above Description. Demonstrate prototype performance through prototype evaluation and modeling or analytical methods over the required range of parameters including numerous deployment cycles as defined in Reference 2. Using evaluation results, refine the prototype into an initial design that will meet Marine Corps requirements in the Description and FDA 510(k) requirements. Prepare a Phase III development plan to transition the technology for Marine Corps use.

PHASE III DUAL USE APPLICATIONS: Develop the full size PREEMS device for evaluation to determine its effectiveness in an operationally relevant environment. Support the Marine Corps for test and validation to certify and qualify the system for Marine Corps use.

The PREEMS device will be an FDA 510(k)-certified commercial medical device that can be used in civil and industrial medical applications. Potential private sector users include hospitals, clinics, paramedics/EMTs, search and rescue teams, disaster relief organizations, and other industries where infection from surgical tools is a common risk.

REFERENCES:

1. �Surgical Sterilization in Austere Military Environments.� Report to the Congressional Defense Committees in Response to House Report 114-139, page 285, which accompanied H.R. 2685, The Department of Defense Appropriations Bill, 2016. https://health.mil/Reference-Center/Reports/2016/07/08/Surgical-Sterilization-in-Austere-Military-Medical-Environments

2. Statement of Need for the Forward Resuscitative Surgery System. OCT 2001. (uploaded to SITIS)

3. Development of a Portable Ozone Sterilization System with Onboard Oxygen Generation, Naval Medical Research Unit, San Antonio. NAMRU-SA Report #2016-91; DEC 2016. (uploaded to SITIS)

4. U.S. Food and Drug Administration. �510(k) Submission Process�. FEB 2018. https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketNotification510k/ucm070201.htm

KEYWORDS: Sterilization; Autoclave; Medical Sterilizer; Field Sterilization; Medical Devices; Energy Efficiency