In its latest warning regarding the Steris System 1 tabletop liquid chemical reprocessor, the Food and Drug Administration has asked endoscope manufacturers to change their labeling on any devices that currently state they can be reprocessed in the SS1.
"If your devices are labeled for use with the SS1, then they are misbranded under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act because they fail to bear adequate directions for use," the agency wrote in a letter to manufacturers last week.
The letter advises companies to immediately review and revise all labeling and online instructions for reusable medical devices that reference the SS1. If the SS1 is the only reprocessing method specified for a device, manufacturers should "take immediate action to validate at least one reprocessing method using legally marketed devices," says the FDA.
The FDA also urges manufacturers to consider adding a notice in their product packaging that states, "The STERIS System 1 (SS1) is not a legally marketed device." The agency itself sent a warning to healthcare facilities in December 2009 stating that the SS1 hadn't been approved in its currently marketed form. If you're currently using the SS1 to reprocess medical devices, you have until August 2011 to transition to a legally marketed alternative device.
Irene Tsikitas
