“Chemical Indicators (Verify SixCess Class 6 Challenge Packs and Chemical Indicators) Should Not Replace Biological Indicators (BIs)”
Steris Corporation has developed chemical indicators that have been approved by the FDA to “monitor physical conditions”. While the FDA has approved this use, they recently issued this Warning Letter because the Steris literature appears to imply that their indicators remove the need for Biological Indicators. Biological indicators, as noted above by the FDA, measure the sterility assurance of the removal of microorganisms.
“The… FDA has reviewed several brochures and other promotional materials as well as the website for STERIS Corporation’s Verify SixCess Class 6 Challenge Packs and Chemical Indicators. Chemical indicators are devices within the meaning of section 201(h) of the Federal Food, Drug and Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) Cosmetic Act. The labeling originally submitted by Steris to the Office of Device Evaluation (ODE) in the 510(k)s for the Verify Chemical Indicators and Challenge Packs included the following claim:
“The performance of the Verify (specific name) indicator exceeds that of biological indicator kill and meets the requirements of ANSI/AAMI/ISO 11140 for Class 6 steam indicators.”