Portable Ruggedized Energy Efficient Medical Sterilizer (PREEMS)
Navy SBIR 2018.2 - Topic N182-096
MCSC - Mr. Jeffrey Kent - email@example.com
Opens: May 22, 2018 - Closes: June 20, 2018 (8:00 PM ET)
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
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
Autoclave; Medical Sterilizer; Field Sterilization; Medical Devices; Energy