Ultra-Lightweight Sterilizer

Period of Performance: 12/05/2003 - 12/04/2005

$730K

Phase 2 SBIR

Recipient Firm

TDA Research, Inc.
12345 W. 52nd Ave. Array
Wheat Ridge, CO 80033
Principal Investigator

Abstract

A portable sterilizer for medical and dental instruments is needed to enhance the military's far-forward medical capabilities. This system must be extremely lightweight, easy to use and must function without external power. In Phase I, TDA Research, Inc. (TDA) demonstrated the feasibility of our ultra-lightweight portable sterilizer, and, in this Phase II project, proposes to complete its development. In Phase I TDA determined the conditions for effective sterilization, produced prototype sterilizers and demonstrated that they achieve complete sterilization in less than 30 minutes. The ultra-lightweight sterilizer was effective against bacterial spores on stainless steel surfaces, including commercial medical instruments. Prototypes indicate that the complete unit will weigh less than one ounce, providing valuable capability at minimal weight and low cost. Reprocessing medical/dental instruments in the field with the ultra-lightweight sterilizer will allow medics to carry fewer instruments total, lowering the weight of the aid bag. In Phase II we will complete the design and use automated packaging equipment to prepare units for evaluation. In addition to a comprehensive in-house test program, we plan two field tests that will allow us to evaluate performance under realistic conditions. We will submit a 510(k) Premarket Notification to the Food and Drug Administration. The ultra-lightweight sterilizer will enhance medical support to troops in the field at a minimal weight. It will also find use in civilian disaster relief and in developing countries where conventional autoclaves are unavailable or power supplies are unreliable.