Why did the company do this, back in 2009 they had issues and this is great to see the company working to solve it and look how many years we have in this research and development, 5. It takes time and there’s a lot of robotics and algorithms that go into a project like this.
This process if I am reading correctly speeds up the time a bit to confirm that devices have been sterilized properly and ready for use. All the bean counters with measuring medical staff productivity will probably be all over this one:) BD
The FDA recently granted permission for marketing of the Verify Cronos Self Contained Biological Indicator (SCBI), a new test that can help speed the determination of the effectiveness of steam sterilization of reusable medical devices.
According to the test’s manufacturer, Steris Corporation, the Verify Cronos SCBI is the first biological indicator test that gives test results in two hours.
“This is a novel and innovative use of recombinant DNA technology in biological indicator tests,” said Christy Foreman, director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health. “By providing faster confirmation of sterilization, this innovation may help health care facilities provide their medical staff with a faster turnaround of their sterilized reusable devices.”
To support its FDA petition, Steris conducted a number of tests to ensure the performance of the Verify Cronos SCBI. This included subjecting more than 300 Verify Cronos SCBIs to a partial sterilization cycle and then comparing results after two hours and at seven days of incubation. The results showed that samples that fluoresced at two hours also exhibited growth at seven days.