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Hospital safety notebook: FDA approves new Steris System 1 alternative


June 1, 2010

Hospital safety notebook

FDA approves new Steris System 1 alternative

The FDA has approved a new alternative system to the Steris System 1 (SS1) processor—which came under federal fire because of alleged infection control risks with the device—but not without some confusion.

The Steris System 1E (SS1E) is a liquid chemical sterilant processing system that is used to process reusable heat-sensitive devices (e.g., endoscopes and their accessories) that cannot be processed using steam. The FDA cleared the SS1E March 16 and publicly posted an announcement April 5. 

“This is good news for our [SS1] customers, and we look forward to working with them as they continue their transition to acceptable alternative technologies,” Walt Rosebrough, president and CEO of Steris Corp. in Mentor, OH, said in a statement.

The original SS1 is a popular sterilizing device used by thousands of hospitals and clinics in the United States. The FDA said Steris modified the SS1 and the agency hasn’t approved the modifications yet.

Steris has been critical of the FDA’s stance, saying there has been no documented case of infection caused by the SS1 when the equipment is used properly.

The FDA has asked hospitals to transition away from the SS1 to alternative reprocessing systems by August 2011.

“The SS1E may be considered as an alternative to the SS1 for processing compatible heat-sensitive devices, as healthcare facilities transition away from the SS1,” the FDA said.

Items reprocessed in the new SS1E are not considered sterile and should be used immediately, the agency said. This has confused some in the healthcare industry who had expected an SS1 alternative to sterilize items. We’ll update you as further information becomes available on this aspect.

Steris is hopeful the SS1E will fill the gap created by the SS1 controversy. “Steris continues dialogue with the agency to close out the remaining System 1 issues and expects to announce a transition plan in the near future,” it said.

To read the full FDA approval, go to www.fda.gov and search for K090036.


California says low humidity raised the risk of surgical fires, leading to a $100,000 fine

California health officials this week punished a hospital that allegedly raised the risk of fires in a labor and delivery operating room (OR).

According to records reviewed by the California Department of Public Health, three scheduled Caesarean sections were performed at Southwest Healthcare System in Murrieta October 26 and 28, 2009, despite low humidity levels noted earlier on those days in the surgical suites. Low humidity in an OR increases the risk of fire from sparking surgical instruments, much like dry days can raise the potential for brush fires.

The state said the alleged lapse constituted an immediate jeopardy to patient safety and issued a $100,000 penalty against Southwest Healthcare.

The hospital planned to dispute the findings.


Minnesota hospital fined $7,000 for fatal fall

A hospital and a window washing company were both fined by Minnesota’s OSHA agency stemming from the death of a window washer who fell from scaffolding at the facility in September 2009.

Park Nicollet Methodist Hospital in St. Louis Park, MN, was fined $7,000 by the state, and CID Services, LLC, of Minnesota was fined $28,750, according to records available from federal OSHA.

Minnesota OSHA cited the hospital under the state’s suspension scaffolds standard, which requires scaffolds to be installed with proper support and workers to be provided with safety belts. CID Services was also cited under the scaffold standard, as well as under a state statute requiring employers provide personnel with hazard-free workplaces.

Both the hospital and CID Services were contesting the citations, according to WCCO-TV in Minneapolis.

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