Takayuki Imasaka | PubMed Health

PubMed2005

Validation of low-temperature steam with formaldehyde sterilization for endoscopes, using validation device.

BACKGROUND: Validation of sterilization is an important step before clinical use of medical equipment. Adequate validation of sterilization of the endoscope has not been reported. One reason for this is the lack of suitable devices for validation. METHODS: The VDES (validation device for endoscope sterilization; Olympus prototype model, Olympus, Tokyo, Japan) was designed in two types (type A and type B) and resembles gastroscopes and duodenoscopes, respectively. Each type consists of inner and outer tubing and a central capsule containing a biological indicator. The device was designed to examine the effectiveness of low-temperature sterilizers, such as ethylene oxide gas, hydrogen peroxide gas plasma, and low-temperature steam with formaldehyde (LTSF) sterilizer. The aim of this study was to validate the sterilization of GI endoscopes by the LTSF sterilizer. Sterilization was assessed using both types of VDES after a 60-min application of LTSF. RESULTS: Culture of the biological indicator confirmed the complete eradication of the bacteria in a total of 10 experiments with each type of VDES after LTSF sterilization. CONCLUSIONS: Our results confirm that the LTSF sterilizer may sterilize endoscopes currently distributed by Olympus. Commercialization of VDES will make it possible to evaluate the reliability of sterilization when it is set in the sterilization device with endoscopes.

Bacillaceae↗

PubMed2005

A comparative study of ethylene oxide gas, hydrogen peroxide gas plasma, and low-temperature steam formaldehyde sterilization.

OBJECTIVE: To compare the efficacies of ethylene oxide gas (EOG), hydrogen peroxide gas plasma (PLASMA), and low-temperature steam formaldehyde (LTSF) sterilization methods. METHODS: The efficacies of EOG, PLASMA, and LTSF sterilization were tested using metal and plastic plates, common medical instruments, and three process challenge devices with narrow lumens. All items were contaminated with Bacillus stearothermophilus spores or used a standard biological indicator. RESULTS: EOG and LTSF demonstrated effective killing of B. stearothermophilus spores, with or without serum, on plates, on instruments, and in process challenge devices. PLASMA failed to adequately sterilize materials on multiple trials in several experiments, including two of three plates, two of three instruments, and all process challenge devices. CONCLUSIONS: Our results suggest that PLASMA sterilization may be unsuccessful under certain conditions, particularly when used for items with complex shapes and narrow lumens. Alternatively, LTSF sterilization demonstrates excellent efficacy and is comparable to EOG sterilization. LTSF could potentially act as a substitute if EOG becomes unavailable due to environmental concerns.

Equipment and Supplies↗