SBIR-STTR Award

Development of a cold sterilant for field medical use
Award last edited on: 11/12/02

Sponsored Program
SBIR
Awarding Agency
DOD : Army
Total Award Amount
$922,211
Award Phase
2
Solicitation Topic Code
A91-219
Principal Investigator
Raymond C Kralovic

Company Information

STERIS Corporation (AKA: STERIS plc)

5960 Heisley Road
Mentor, OH 44060
   (440) 354-2600
   investor@steris.com
   www.steris.com
Location: Multiple
Congr. District: 14
County: Lake

Phase I

Contract Number: DAMD17-92-C-2049
Start Date: 4/1/93    Completed: 3/31/95
Phase I year
1991
Phase I Amount
$49,987
Field medical use of many surgical instruments, including delicate instruments such as endoscopes, requires cold sterilization, cold being defined as a temperature Tange between ambient (25C) and moderately elevated (up to 60C). Because of hazards in transporting and using ethylene oxide, it has been eliminated from field medical use; and glutaraldehyde, a disinfectant which has "any undesirable Characteristics involving logistics Support, user safety and product effectiveness, is currently being used as a replacement. Required is a safe and effective dry powder sterilant that can be added to water to effect the cold sterilization of instruments. It should be packaged as an inert powder that can be safely and efficiently transported and stored; and the waste solution should not pose a toxic hazard to users.. It is proposed to formulate one or more powdered cold chemical sterilants for field medical use based upon proprietary 1ow temperature chemical sterilization technology developed by the offeror for use in automated hospital equipment, and demonstrate that these products: 1) are effective against bacterial endospores and viral, bacterial and fungal contaminants; and, 2) otherwise meet medical field use sterilization requirements set forth by the United States Army Medical Research and Development Command.

Benefits:
Successful development of a cold sterilant(s) will provide safe and effective alternatives to ethylene oxide gas, a sterilant which is highly toxic and a known carcinogen, and to glutaraldehyde; which is, unsatisfactory because of known efficacy and toxicology problems. Therefore, the proposed cold sterilant, in addition to meetlng project objectives, will have broad application in other military and civilian health care environments worldwide. '

Keywords:
Sterilization Medical Instruments Dry Chemical Sterilant Field Hospital

Phase II

Contract Number: DAMD17-92-C-2049
Start Date: 4/1/93    Completed: 3/31/95
Phase II year
1993
Phase II Amount
$872,224
Field medical use of many surgical instruments, including delicate instruments such as endoscopes, requires cold sterilization, cold being defined as a temperature range between ambient (25oC) and moderately elevated (up to 60oC). Because of hazards in transporting and using ethylene oxide, it has been eliminated from field medical use; and glutaraldehyde, a disinfectant which has many undesirable characteristics involving logistics support, user safety and product effectiveness, is currently being used as a replacement. Required is a safe and effective dry powder sterilant that can be added to water to effect the cold sterilization of instruments. It should be packaged as an inert powder that can be safely and efficiently transported and stored; and the waste solution should not pose a toxic hazard to users.