President
CurrentOversee operations of a ISO 17025 accredited validation laboratory in a new state of the art facility. HIGHPOWER has been validating reusable medical/dental devices for device manufacturers for over 30 years and specializes in the cleaning, packaging and sterilization validations of reusable medical devices. Go to www.highpowervtls.com to learn more about the wide range of validation, testing and services available to medical device manufacturers. HIGHPOWER is ASP factory trained to perform STERRAD® functionality & efficacy validation testing and has every major FDA cleared sterilization process in-house. Our scientists, technicians and technical managers are available to assist device manufacturers in all of their validation or compliance needs. HIGHPOWER has an experienced team to assist in the performance of usability studies, limits of reuse or material compatibility studies. Device cleaning, packaging and sterilization studies our specialty.ACHIEVEMENTS• Developed a line of FDA cleared chemical indicators (type 1, 5 and 6 indicators).• Developed a line of FDA cleared biological indicators.• Developed a line of FDA cleared self-seal sterilization pouches with a type 4 internal indicator.• Advised in the development of three patents for medical devices.• Created a company that validates the cleaning, packaging and sterilization processing of reusable medical devices, sterilizers and healthcare washers.• Advised and guided clients in developing sterilization and cleaning processes for FDA 510K submissions.• Advised and guided clients in developing validation processes for sterilizers seeking FDA 510K submissions.• Implemented a EtO sterilization program with the NYS Department of Environmental Conservation.• Consulted on equipment sterilization for fighting white-nose syndrome - an emergent disease of hibernating bats.• Consulted on EtO sterilization of a display housing a replica of Van Gogh’s ear grown using the artist's genetic DNA.
