FDA Gives Hospitals More Time to Transition from Steris SS1
After further consideration, the Food and Drug Administration (FDA) has extended the deadline to 18 months for hospitals to transition away from using the Steris System 1® (SS1) processor.
Previously, FDA officials said the transition could be made within three to six months. But after hearing from hospitals and others in the industry, the "FDA now understands that a three-to-six-month transition period may present significant difficulties for some healthcare facilities, which could, in turn, adversely affect patient care," the agency said.
Using the FDA's original December 2009 announcement of the six-month timeframe, the new extension would bring the deadline to August 2011.
Hospitals using the SS1 should be figuring out what their next sterilizer will be and how quickly they can switch over, Steven Silverman, assistant director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research, told HealthLeaders Media's sister publication, Briefings on Hospital Safety.
In an initial safety notice first published in December, the FDA said Steris modified the SS1 and that the agency hasn't approved the modifications yet.
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, has criticized the FDA's assertions, saying there has been no documented case of infection caused by the SS1 when the equipment is used properly.
About 23,000 SS1s have been used in more than 5,000 hospitals and clinics in the country, according to Steris.
Many hospital operating rooms, gastrointestinal laboratories, and ambulatory surgery centers used the SS1 to sterilize or disinfect medical devices, said Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, president and CEO of Seavey Healthcare Consulting in Arvada, CO.
The processor was the only product of its kind for many years, but in recent memory, several alternatives have come on the market, including one from Steris itself, Seavey said.
The FDA does not expect to enforce the 18-month timeline for hospitals that don't stop using the SS1.
"But these facilities should be aware that the current SS1 is a misbranded and adulterated medical device because it has not been cleared by FDA as safe and effective for its labeled claims," the agency said.