The FDA is urging users of the Steris System 1 to find an alternative method to sterilize and disinfect instruments, saying in a safety alert yesterday that it has received reports of the popular SS1 tabletop liquid chemical reprocessor malfunctioning and that it could cause such "serious injuries" as infections to patients. The FDA also said it had received "reports of injuries, mostly burns from exposure to the sterilant solution, to health care facility staff operating the device," although it called these reports infrequent and said they could be the result of user error.
A Steris spokesman said company officials are reviewing the FDA's safety warning, which is the latest salvo in an ongoing battle between the FDA and Steris over the SS1.
In May 2008, the FDA sent a warning letter to Steris saying that because the company had changed the SS1 and the FDA had never approved or cleared the modified product, Steris would need new approval from the agency to sell an updated version of the device. Steris disagreed with the FDA's assessment.
In January 2009, Steris said it would comply with an agreement with the FDA and stop new SS1 sales with 1 exception: It would sell the device in the U.S. "on a replacement basis only." Steris also agreed to work with its customers to transition them to legally marketed replacements for SS1.
The FDA issued yesterday's warning letter because, based on a recent inspection of Steris and meetings with the firm, the agency "isn't satisfied that the firm has been working effectively to transition its customers to replacements for the SS1." In addition, the FDA claims that Steris has been reassuring customers that there is no need for a change in their clinical practice and that the company is continuing to design or redesign new accessories for the SS1.
The FDA has prepared a question-and-answer document.
Dan O'Connor
