Steris System 1 (SS1) Processor: Second 6 Month Extension for Health Care Facilities to Replace STERIS System 1 with a Legally-Marketed Alternative
FDA has extended the transition period to period to August 2, 2012, with the following requirements:
United States Customers currently using the STERIS System 1 (SS1) may continue to receive System 1 sterilant and other support after February 2, 2012, only if those Customers have placed orders for products to replace all remaining SS1’s in their possession and have provided a properly completed Certificate of Transition.
The Requirement to continue to receive System 1 sterilant and other support after February 2, 2012 are the following:
- Complete and sign the STERIS Certificate of Transition form,
- Provide the date the purchase order for replacement product was placed and the proposed installation date, and;
- Return the completed Certificate of Transition to STERIS.
According to STERIS, all programs and support for the SS1, including sale of sterilant and accessories as well as service support will expire no later than August 2, 2012. STERIS will discontinue support for the SS1 in the United States on February 2, 2012, for those customers who do not provide a completed Certificate of Transition.
As a reminder, All SS1 processors should be returned to Steris or destroyed. They should not be auctioned, exported for sale outside the United States, or otherwise resold.
Customers should contact Steris at 1-800-548-4873, for more information.
In December, 2009, the FDA announced that Steris had modified the SS1 processor and that the FDA had not approved or cleared the modified SS1 for its labeled claims. STERIS Corporation has chosen not to seek the FDA’s clearance of this device so its use should be discontinued.
The FDA’s primary objective is that safe and effective alternative reprocessing devices be identified and placed into use as soon as possible, without compromising either patient care or employee health. During this transition period, the FDA will monitor the availability and supply of legally-marketed replacement products.
The FDA does not expect to take regulatory action against health care facilities for failing to replace SS1 units within the transition period. However, these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by the FDA as safe and effective for its labeled claims. As a result, health care facilities should transition to alternative reprocessing devices as soon as possible.