Reusable Medical Device Validation
iuvo BioScience is 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 using approved testing methods based on AAMI TIR12:2010, AAMI TIR30:2011 and FDA guidance documentation.
Iuvo BioScience 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.
- Over 20 years of experience in evaluating the reprocessing of reusable medical devices ensures iuvo BioScience can devise a cleaning and sterilization regimen that can be maintained over the useful life of the device. Methods available include—
- Steam sterilization
- EtO sterilization
- Sterrad sterilization
- Liquid chemical sterilization
- We perform low, intermediate and high-level disinfection studies following FDA and AAMI recommendations.
- 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 and identifying problem areas prior to initial production.
- We are experienced in the design and execution of protocols for the repetitive exposure of devices to both sterilants and disinfectants to assess functionality and biocompatibility.
- In addition to sterilization and disinfection studies, iuvo BioScience scientists design and perform cleaning studies for your device. Cleaning efficacy is commonly determined using a sensitive protein assay, although client-specified methods may be used to assess contamination removal. We are experienced in preparing and executing protocols for cleaning medical devices using both manual and automatic washing procedures.
- We perform equivalency assessments to validated master products using AAMI guidelines.
Medical Device Cleaning Studies
- The iuvo BioScience Chemistry Department works with our Reusable Device group to design and perform cleaning studies. Cleaning efficacy may be determined by use of a total protein assay, or by other client-specified measures of contamination removal.
- Our experts will come to your site to plan and conduct validation or qualification studies on your equipment and processes including both steam and ethylene oxide sterilizers.