On December 3, the U.S. Food and Drug Administration (FDA) published a notice on its website regarding the regulatory status of the STERIS System 1 Processor (SS1). The SS1 is used in surgical and endoscopy suites for reprocessing, including sterilizing or disinfecting medical devices. The FDA reported that STERIS had significantly modified the SS1 without FDA approval or clearance for the modified product.

In its notice, the FDA stated it has not determined the safety or effectiveness of the SS1's labeled claims, including that the SS1 sterilizes medical devices. The agency cautions that use of a device promoted to sterilize/disinfect medical or surgical devices but that does not properly perform those functions poses risks to patients and users, including risks of transmitting and/or exposure to hazardous chemicals. The FDA says it has received some reports of malfunctions of the SS1, and reports of injuries, primarily to health care staff from burns from exposure to the sterilant solution.

In a December 4 Stakeholder Conference Call, FDA representatives reiterated their concerns of the SS1. The FDA representatives said the agency believed STERIS had been in the process of transitioning customers to legally market alternative devices. However, after communications with STERIS and an inspection of their records, the transition was not to the agency's satisfaction. The FDA acknowledges STERIS has informed the public that it has a new device under FDA review, but the agency cannot say if or when the new device will be cleared by the FDA. Agency representatives further state that the FDA considers all SS1s that are currently in use to be subject to the notice and concerns that the FDA has, including the sterilant formulation. According to the FDA representatives, the modifications to the SS1 were made over a long period of time after the SS1 was approved in 1989.

The FDA representatives emphasized they are not saying to immediately stop using the SS1, but for a facility to take steps to evaluate its situation and what other products it has suitable for reprocessing devices; if a facility does not have alternatives, it should seek out legally marketed products and make arrangements to transition promptly.

STERIS has also published a notice to its customers, in which it disagrees with FDA's December 3 notice and that the SS1 is safe and effective when used as directed. STERIS says it is working to engage in further dialogue with FDA about this matter and is actively communicating with its customers. The company has contact information for customers to report any serious adverse event that they suspect is associated with the use of the STERIS System 1.

More Voices