FDA has extended the transition period to February 2, 2012. All healthcare facilities must be transitioned from Steris Corporation’s modified System 1 processor (SS1) to legally-marketed alternative devices by that time.
FDA does not anticipate any future extensions to the transition period.
As FDA announced in December 2009, 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’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. 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 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:
Questions can be directed to the Office of Compliance via mail: CDRH, 10903 New Hampshire Avenue, WO 66, Silver Spring, Maryland 20993 or by telephone message at: 1-877-260-3731.