The FDA recommends hospitals seek alternatives to certain Steris processor

Hospital Safety Insider, December 9, 2009

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The Food and Drug Administration (FDA) is suggesting that hospitals consider alternatives to a popular sterilizing device.
In a safety notice published last week, the FDA said Steris Corp. of Mentor, OH, modified its Steris System 1 (SS1) processor and that the agency hasn’t approved the modifications yet. The SS1 is used in surgical and endoscopy suites for sterilizing or disinfecting medical devices.
The agency also said that despite discussions with Steris since 2008, the FDA is not satisfied with the company’s response to concerns about providing hospitals with adequate replacements to the SS1.
The FDA notice made the following recommendations:
  • If hospitals have an acceptable alternative to the SS1 to meet sterilization and disinfection needs, facilities should transition to that alternative as soon as possible to ensure patient safety
  • If hospitals don’t have an acceptable alternative, facilities should promptly assess patient care needs and sterilization and disinfection requirements, and take steps to obtain legally marketed substitutes for the SS1
Steris criticized the FDA’s alert in a statement. “We disagree with the FDA’s recent notice and are working to engage in further dialogue with the agency about this matter,” said Walt Rosebrough, Steris’ president and CEO.
About 23,000 SS1s have been used in more than 5,000 hospitals and clinics in the country, according to Steris.
“There has not been a documented case of infection directly caused by a System 1 Sterile Processing System when proper guidelines and instructions are followed by certified health professionals,” the company said in correspondence with customers.
The FDA countered that it has received some reports of SS1 malfunctions that had potential to cause infections. “Infections that occur after a procedure using a medical device reprocessed in the SS1 may be difficult to attribute to the SS1 and may go unreported,” the notice said.

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