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ECRI Institute Issues Steris System 1 High Priority Alert and Recommendations: Free Guidance to Help Hospitals Map out Transition to Alternative Reprocessing Methods
Date:12/14/2009

PLYMOUTH MEETING, Pa., Dec. 14 /PRNewswire-USNewswire/ -- In response to an FDA notice issued on December 3, 2009, in which the Agency recommended that healthcare facilities discontinue use of the STERIS System 1® (SS1) sterile processing system, hospitals throughout the U.S. are faced with the task of finding acceptable alternatives to that product. According to the FDA, STERIS made changes to the design of the SS1 that may affect the safety or the effectiveness of the system without first submitting premarket notification (i.e., 510 [k]).

ECRI Institute®, an independent, nonprofit organization that researches the best approaches to improving patient care, has issued a high priority medical device alert and recommendations to assist hospitals in selecting and transitioning from SS1 to alternative systems for endoscope reprocessing. These recommendations and a side-by-side product comparison chart are available for free download from ECRI Institute's Web site.

"In light of FDA's notice, healthcare facilities have little choice but to discontinue use of the SS1 in the coming months," says ECRI Institute's James P. Keller, vice president of technology evaluation and safety, ECRI Institute. "We caution hospitals against rushing through what needs to be a careful, comprehensive, and analytical process."

To support healthcare providers in contending with this regulatory action, ECRI Institute's Health Devices System(TM) is making the following exclusive guidance and product specification resources available to healthcare providers:

  • ECRI Institute SPECIAL REPORT S0192 01: STERIS--System 1 Sterile Processing
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SOURCE ECRI Institute
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