Minimizing the Risk of Medical Devices Spreading Infectious Disease
Our mission is to help Class I and II medical device manufactures make infection control a priority by offering our expertise and testing services at every phase of device design and post device release. We are dedicated to operating as an unbiased and independent third-party chemical compatibility test facility, bridging the gap between medical device and cleaner/disinfectant manufactures. Our consulting team consists of subject matter experts in the area of medical device infection control, reprocessing, biocompatibility, and sterilization and packaging of single use devices. Our backgrounds have been focused in the disposable and reusable medical device space, allowing us to work with manufactures of a wide variety of devices.
John Lenz
John has been helping Class I and II reusable medical device manufactures with reprocessing and infection control projects since earning a bachelor’s degree in Chemical Engineering from the University of Washington in 2015. He manages the Disinfectant Test Service offered at our Arlington facility.
Contact John if you would like help with an infection control related project for reusable Class I and Class II medical devices. Past project include:
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- Designing and Validating reprocessing instructions intended for the final user
- Cleaner and Disinfectant Selection – Understanding the popularity and relevance to infection control of particular cleaners and disinfectants
- Designing and coordinating manual cleaning and disinfection efficacy validations
- Chemical compatibility with hospital grade cleaners and disinfectants
- Material selection and device designs that improve cleaning efficacy and resistance to chemical germicidal agents
- Biocompatibility evaluations
- Forming internal plans, procedures, etc… in accordance with medical device standards and best practice documents:
- Reprocessing Medical Devices in Health Care Settings (2015): Validation Methods and Labeling Guidance
- CDC – Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008
- ISO 17664:2017
- AAMI TIR 12:2010
- AAMI TIR 30 2011/ (R) 2016
- AAMI TIR 34:2014
- ANSI/AAMI/ISO 10993-5:2009/(R)
- ISO 10993-1:2018
Get in Touch
Or call — 206.775.4233