reusable medical device testing
Welcome to Ethox STS Reusable Medical Device Services
Ethox STS has been a leader in the industry, refining procedures for conducting studies to establish the efficacy of reprocessing reusable instruments, trays and containers. We assist clients to fulfill FDA requirements.
Ethox STS has been a pioneer in the efficacy testing of a broad spectrum of complex instruments and sterilization containers providing input for user manuals and for 510(k) submissions.
our focus
 • Ethox STS has over 20 years of experience in evaluating the reprocessing of reusable medical devices to ensure that effective cleaning and sterilization can be maintained over the useful life of a device.
• Our team goes beyond testing to ensure that our clients’ requirements, both internal and regulatory, are met.
• We are experts in working with prototype devices, identifying problem areas for our clients prior to initial production.
our services
• Efficacy evaluations consisting of disinfection, cleaning, and sterilization studies for instruments and sterilization/penetration and microbial barrier studies for containers.
• Repetitive exposures in steam, EO, Sterrad and disinfectants can also be provided to permit assessment of functionality and biocompatibility.
• Complete analysis of ethylene oxide residuals by gas chromatography
related services
Coordinating Client Projects
Our reusable device department performs studies separately or in conjunction with other Ethox STS services. This approach serves to streamline clients' studies utilizing our multi-service capabilities.
• Microbiology testing
• Toxicology testing
• Analytical Chemistry
• Contract Sterilization
• Biological Indicators
certifications
Our level of experience comes from involvement in hundreds of varied projects over many years. Ethox STS is an active participant in AAMI sterilization committees and has also been active in publishing and presenting technical works related to reusable products.
See more certifications
To learn more call Gary Chilson at 1.800.836.4850 ext 267 or e-mail us!
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