June 23, 2010
FDA has granted a two-week extension, until July 2, 2010, for healthcare providers using the STERIS System 1 (SS1) to submit a Certificate of Medical Necessity (CN) form to STERIS in order to continue receiving service and supplies from the manufacturer.
Pursuant to a Consent Decree of Permanent Injunction entered on April 20, 2010, STERIS must obtain a signed CN from each healthcare provider who wants STERIS to continue providing SS1 sterilant, service and accessories to that provider during an 18-month transition period. The injunction requires STERIS to stop selling the SS1 because the device was misbranded, and the transition period gives healthcare providers time to replace their SS1 with a legally-marketed alternative. After the transition period ends on August 2, 2011, Steris will no longer provide service, parts, accessories, or consumables for the SS1.
The two-week extension was granted because, according to company estimates, about 2,000 SS1 customers have not yet returned their CNs. The extension provides remaining healthcare providers additional time to submit their CNs without interrupting patient care.
FDA expects that STERIS will work aggressively to obtain the outstanding CNs during the extension period and the Agency does not anticipate extending this deadline further. As part of the extension, FDA is requiring STERIS to provide regular updates of its progress in collecting the remaining CNs.
Additional information on this issue may be found at: http://www.fda.gov/MedicalDevices/ Safety/ AlertsandNotices/ucm194411.htm and questions can be directed to Patrick Weixel at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO66, Silver Spring, Maryland, 20993, or by email at firstname.lastname@example.org.