The FDA notified healthcare facilities in December that STERIS Corp. significantly modified its SS1 processor without clearing the modifications with the FDA. Thus, the FDA has not approved the SS1 as safe or effective for its labeled claims, including claims that it sterilizes medical devices. The FDA urged facilities to cease use of the device.
In the letter to endoscope manufacturers, the FDA warned that medical devices labeled for use with the SS1 are considered misbranded under section 502(f)(1) of the Federal Food, Drug and Cosmetic Act because they fail to bear adequate directions for use. The FDA instructed manufactures with devices labeled for use with the SS1 to revise labeling to correct these variations and remove all statements indicating that devices may be reprocessed with the SS1.
The FDA letter recommends manufacturers take the following actions:
- Review immediately all labeling for your reusable medical devices, including online information, for references to the SS1. These materials should be revised as outlined above in order to comply with applicable labeling requirements.
- Consider immediately adding to your product packaging a notice stating, “The STERIS System 1 (SS1) is not a legally marketed device” and that your labeling will be revised to identify reprocessing methods using legally-marketed devices.
- Take immediate action to validate at least one reprocessing method using legally marketed devices if the SS1 is the only method described for reprocessing your device. Following validation, your labeling should be revised as indicated above, in order to comply with applicable labeling requirements.
- Determine if your labeling changes require a PMA or 510(k) submission.
a. Relabeling a product approved in a PMA may require the submission of a PMA supplement.
b. Relabeling a reusable device cleared in a 510(k) premarket notification may require the submission of a new 510(k).
Read the FDA’s letter to endoscope manufactures regarding the SS1 processor.
