FDA Extends Time Period for Transition from STERIS System 1 to Alternative

The Food and Drug Administration (FDA) announced today that it is extending the total recommended time period for transitioning from the STERIS System 1 processor to legally marketed alternatives. This document updates the “FDA Notice: Concerns about the Steris System 1 Processor, Components, and Accessories, and FDA Recommendations,” issued Dec. 3, 2009. The notice reads as follows:

“The purpose of this document is to inform you that FDA is 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 Dec. 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.

“During a Dec. 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.”

The letter was signed by Timothy A. Ulatowski, director of the Office of Compliance for the Center for Devices and Radiological Health of the Food and Drug Administration.

Additional information on this issue may be found at: http://www.fda.gov/MedicalDevices/ Safety/AlertsandNotices/ucm194411.htm

To read the customer letter from STERIS Corp., CLICK HERE.