Hi all, here's information on MLSC's instrument sterilization.
(From News release dated April 16,1996.)
MEDICAL DISCOVERIES ANNOUNCES SUCCESSFUL SECOND PHASE TESTING OF PROPRIETARY AGENT FOR RAPID INSTRUMENT STERILIZATION
Marlin Toombs, vice president and director Of MLSC announced the successful completion of a second critical evaluation regarding the use of MDI-P, it's proprietary sterilizing agent to sterilze dental instruments.
The evaluation conducted at the Baylor college of Dentistry per FDA-recommended criteria for 510(k) premarket notification in this category, determined that MDI-P could effectively sterilize heavily contaminated dental instruments and metal surfaces in considerably less time than methods currently utilized in the industry. Founded in 1905, the Baylor College of Dentistry is widely recognized for it's excellence in the field of dentistry.
This second phase represents completion of a successful feasibility study necessary toward the registration of MDI-P for marketing with the FDA and EPA (Environmental Protection Agency). THe studies were initiated jointly by Medical Discoveries and Steril*Med, Inc. (Houston, Texas), an affiliate of Cooley & Cooley Ltd., which manufactures Copalite (tm) dental products for worldwide distribution. The studies investigated the ability of MDI-P to sterilize internal areas of two widely used dental handpieces--the Kavo and Star--
contaminated with spores of Bacillus stearothermophilus, a highly resistant FDA recommended test organism. After immersion in MDI-P for six minutes, none of the handpiece componets demonstrated B. stearothermophilus organisms following overnight culture of the handpieces.
Additional experiments were also undertaken to establish MDI-P's efficacy in sterilizing metal surfaces, such as those used in non-hinged medical and veterinary instruments. As with the dental handpieces, no viable B. stearothermophilus were observed following a six minute exposure to MDI-P after an overnight culture.
MDI-P's six minute sterilization cycle comnpares favorably to sterilization methods currently in use. The autoclave--the most common sterilization method--takes 20 minutes to complete at temperatures of 121 C and 15 pounds per square inch of pressure. Ethylene oxide, a toxic gas, requires 18 hours for sterilization. The STERRAD sterilization system using hydrogen peroxide requires over one hour, and the Plazlyte sterilization system uses a chemical sterilant which requires approximately 10 to 12 hours to be effective.
Cooley & Cooley market research indicates that the approximately 130,000 dentists in the U.S. spend an average of $17,000 annually for repair and replacement of dental hand pieces. While it is anticipated that the MDI-P sterilization process will reduce repair and replacement costs of specialized, and often intricate, dental equipment, the MDI-P process is also expected to be very cost effective with existing dental and hospital sterilization methods.
Medical Discoveries is currently negotiating with the Baylor College of Dentistry to complete a 510(k) submission to the FDA for the commercial use of MDI-P as a sterilizing agent for medical and dental and veterinary instruments. Once arrangements have been finalized, completetion is estimated to be between six and nine months.
"The results of the Baylor College of Dentistry represents an important milestone in the history of Medical Discoveries, Inc. Importantly, this evaluation underscores the viability of MDI-P's sterilization process with hard evidence," said Dr. Robert Kolstad, Baylor professor of microbiology and director of the sterilization monitoring service. "As Medical Discoveries gets closer to the commercialization of MDI-P, I am proud of my association with a company whose product has such potential to revolutionize the medical sterilization industry."
(I had to hand type this from my investment packet, please excuse any typographical errors...) |
