FDA Approves Marketing of Steam Sterilization Test for Reusable Medical Devices

The FDA has approved marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a test that can help speed the determination of whether steam sterilization of reusable medical devices is effective. Verify Cronos is manufactured by Steris Corporation of Mentor, Ohio.

The SCBI is used in reprocessing, a process used to clean and disinfect or sterilize reusable medical devices so that they can be safely used for more than one patient. According to the FDA, steam sterilization is one method for sterilizing reusable medical devices, such as surgical instruments and endoscopes. It involves loading medical devices into a chamber that is sealed and filled with steam. Specific conditions such as temperature, exposure time and chamber pressure must be maintained in order to kill microorganisms that may be present on the reusable medical devices.


FDA Regulation

The FDA regulates biological indicators (BI) intended to monitor sterilizers used in health care facilities as Class II medical devices requiring premarket notification (21 CFR §880.2800(a)). The effective performance of sterilizers used in health care facilities is important to help prevent nosocomial infections. The use of comprehensive, scientifically sound criteria to evaluate BIs helps ensure the performance of these devices.


The FDA reviewed the data for Verify Cronos SCBI through the “de novo classification” premarket review pathway, a regulatory pathway for low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device.