FDA, Manufacturer at Odds Over Common Sterilizer

Scott Wallask, for HealthLeaders Media , December 8, 2009

Steris Corp. has reacted strongly to a Food and Drug Administration (FDA) recommendation that hospitals consider alternatives to a popular Steris sterilizing product.

In a safety notice published last week, the FDA said Steris 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.

Steris, based in Mentor, OH, issued a statement late Friday criticizing the FDA's alert.

"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 also published Friday.

The FDA countered that it has received some reports of SS1 malfunctions that had the 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.

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

Based on earlier unease from the FDA, Steris sent customers correspondence about its submittal of a new premarket notification for the updated SS1 in January. The SS1 revisions in question include mechanical and software changes to the processor, according to Steris.

Steris has established a dedicated hotline for more information about the SS1 at 440-392-7223.

Scott Wallask is senior managing editor for the Hospital Safety Center. He can be reached at swallask@hcpro.com.

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