For an update on the System 1 situation since this article went to press in the May issue of ICT, CLICK HERE.
Hospitals are scrambling to transition away from the STERIS System 1 processor (SS1) to legally marketed alternatives, as mandated by the Food and Drug Administration (FDA). In its Dec. 3, 2009 notice, the FDA explained that it had not approved or cleared the SS1 for its safety or effectiveness according to its labeled claims; because STERIS Corporation chose not to seek FDA clearance of this device, the agency declared that its use should be discontinued as soon as possible.
In a Feb. 3, 2010 letter to customers, Walt Rosebrough, president and CEO of STERIS Corporation explained that the company submitted a new premarket notification for an updated STERIS System 1, and that the updated system includes the changes outlined in the May 15, 2008 FDA warning letter as well as other technology updates. STERIS submitted this new 510(k) to the FDA on Jan. 5, 2009 and is continuing to seek clearance of this new device. Rosebrough added that STERIS also continues to communicate with the FDA about a transition plan for System 1 users. The SS1 is a low-temperature sterile processing system for endoscopes and other immersible surgical and diagnostic devices.
The FDA extended out the transition deadline by 18 months to August 2011, due in part to healthcare professionals’ concerns about meeting the FDA’s demands. During this time, STERIS will continue to support existing SS1 units, through provision of currently-marketed components, accessories and sterilant, throughout the extended transition period. The FDA will also monitor the availability and supply of legally marketed replacement products.
While this extended transition time facilitates a more thorough assessment and planning strategy by ASCs, experts say it behooves facilities to expedite the process to continue to uphold patient safety. Adding to the need for immediate action is the FDA’s stance on the issue; while it says it does not expect to take regulatory action against healthcare facilities for failing to replace SS1 units within the 18-month transition period, it states, “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.”
“Hospitals and ambulatory surgery facilities are taking steps as quickly as possible to transition to alternative methods of sterilizing heat-sensitive instruments within the time frame required by the FDA in the notification published on Feb. 2, 2010,” says Ramona L. Conner, RN, MSN, CNOR, manager of standards and recommended practices at the Center for Nursing Practice of the Association of periOperative Registered Nurses (AORN). “Facilities are challenged to assess their sterilization needs, evaluate the alternatives, initiate the necessary purchases, educate their personnel, and prepare a smooth transition in a manner that will not compromise patient safety or impact their ability to provide care.”
