Case Medical Inc., a Bloomfield-based manufacturer of medical instrument processing products and services, has recently received U.S. Food and Drug Administration (FDA) clearance for its SteriTite solid bottom container system for V-Pro sterilization of medical equipment.
The SteriTite container system is a family of rigid reusable sterilization containers and inserts used by healthcare facilities to enclose medical devices and instrument sets for sterilization, transport, and storage. The Case Medical SteriTite container and MediTray products have been previously cleared for use in steam as well as low temperature sterilizers.
The new FDA 510k clearance demonstrates that the Case Medical SteriTite Universal Container with solid base previously cleared for pre-vacuum steam, EO, and TSO3 VP4, can now be used for Steris V-Pro maX, V-Pro maX2, V-Pro s2, and V-Pro 60.
Case Medical’s containers are universally compatible with all devices that can be sterilized. Now, healthcare facilities can standardize utilizing the SteriTite solid bottom container with filters in lid only. This configuration increases turnaround, reduces the total weight of the device, eliminates user error, and provides less points of potential ingress for bacteria and other environmental contaminants.
Case Medical, Inc. follows the “overkill method” of sterility assurance to show an elimination of a biological challenge and validated a 365-day event-related shelf life. All SteriTite containers were validated with inner baskets, trays and inserts representative of the company’s MediTray line of products.
Testing was designed to simulate worst-case scenarios with half cycles and end of shelf-life concentrations of hydrogen peroxide. The validation testing was conducted at independent laboratories in accordance with FDA guidance and available ANSI/AAMI standards such as ANSI/AAMI ST77, AAMI TIR 12 and ANSI/AMMI ST79.
Case Medical is an FDA registered and ISO-13485, ISO27001 certified medical device manufacturer of reusable sterilization containers and instrument chemistries. For more information about Case Medical products for infection prevention, go to the company’s website at www.casemed.com.
