FDA Extends Transition Period to 18 Months for Steris System 1 Processor Users

The FDA shared the following notice with SGNA and ASGE, and has asked that we provide this information to our membership. Please forward this notice to any individuals with reprocessing responsibilities.

If you have any questions, please contact the FDA as instructed in the announcement below.

On December 4, SGNA and ASGE alerted members to an FDA notice and conference call regarding the Steris System 1 processor. Today, the FDA issued another notice announcing that they are extending to 18 months from the date of this notice the total recommended time period for transitioning from Steris Corporation’s modified System 1 processor (SS1) to legally-marketed alternative devices. As FDA announced in its December 3, 2009, notice, the Agency has not approved or cleared the SS1 for its labeled claims. Steris Corporation has chosen not to seek FDA clearance of this device and, therefore, its use should be discontinued as soon as practicable.

FDA Summary:

During a December 10, 2009, stakeholder conference call, FDA stated its view that healthcare facilities should be able to transition from the SS1 to legally-marketed alternative devices in three to six months. That recommendation was based on discussions with a number of outside constituents. Since then, Agency staff has heard from many other healthcare providers and professional organizations. FDA now understands that a three to six month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care.

FDA’s primary objective is that safe and effective alternative reprocessing devices be identified and placed into use as soon as practicable, without compromising either patient care or employee health. Therefore, FDA is extending to 18 months the recommended period for transitioning from the SS1 to legally-marketed alternative devices.

At this time, FDA expects that Steris Corporation will continue to support existing SS1 units throughout the extended transition period, e.g., through provision of currently-marketed components, accessories, and sterilant. During this period, FDA will monitor the availability and supply of legally-marketed replacement products. FDA does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period. But these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims. Healthcare facilities should therefore transition to alternative reprocessing devices as soon as practicable.

Additional information on this issue may be found at:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm194411.htm and questions can be directed to Candace McManus, DrPH, at the Office of Compliance, CDRH, 10903 New Hampshire Avenue, WO 66, Silver Spring, Maryland 20993, by e-mail at candace.mcmanus@fda.hhs.gov, or by telephone message at 877/260-3731.

STERIS has established a dedicated hotline for more information - 440/392-7223 - if SYSTEM 1 users have immediate questions. STERIS will also continue to update Customers via www.steris.com as more information becomes available.

FDA Approved Alternatives:

The FDA has provided a list of FDA-approved alternatives to this product.

Past SGNA/ASGE communications regarding the SS1:

http://www.sgna.org/FDAannouncement.cfm

SGNA and ASGE will continue to keep our members updated on relevant FDA notices.