The U.S. Food and Drug Administration (FDA) has sent a letter to endoscope manufacturers concerning reusable medical devices with labels that reference reprocessing by the STERIS System 1 processor (SS1). The FDA had previously notified medical facilities last year that STERIS Corporation had modified the SS1, and that it had not approved or cleared the modified product, nor its claim to sterilize medical devices (see DM 10933).

In the notification letter, the FDA informs endoscope manufacturers that if any devices are labeled for use with the SS1, they are misbranded under section 502(f)(1) of the Federal Food, Drug, and Cosmetic Act due to lack of adequate directions for use, meaning they lack or incorrectly specify preparation for use.

In addition, the FDA says that if the devices are labeled for use with the SS1, manufacturers should revise the labeling to correct any violations by removing all statements indicating that the devices may be reprocessed with the SS1, and specifying only legally marketed reprocessing devices.
The agency goes on to say that manufacturers may be required to identify to the FDA the reusable devices they produce that have been validated for reprocessing by a method other than the SS1, and identify the method that has been validated. Further, the FDA is recommending that manufacturers a) review the labeling of all reusable medical devices for SS1 references, including online information; b) consider adding a notice to product packaging that the SSI is not a legally marketed device; c) as soon as possible validate at least one reprocessing method with legally marketed devices if the SSI is the only method listed for reprocessing the device; and determine if the labeling changes require a PMA or 510(k) submission.

The FDA cautions that using a device promoted or labeled to sterilize or disinfect a medical device, but that does not properly perform these functions, poses patient and user risks.

The FDA letter can be accessed at: http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm201497.htm

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