Hospitals to find acceptable alternatives to STERIS System 1 sterile processing system

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 Systems and Accessories: U.S. Healthcare Facilities Should Begin Plans for Transition to Acceptable Alternatives© [Update]
• Reprocessing Alternatives for Flexible Endoscopes©, a matrix of product specifications for 14 models that can be considered for reprocessing of flexible endoscopes

"Until the transition can be completed--a process, that given its complexity and importance, may take several months or more depending on the unique circumstances of each user--ECRI Institute believes that it is reasonable to continue using the SS1 as each facility deems necessary to support clinical needs," adds Keller.

Full access to the December 11, 2009, priority alert, "STERIS--System 1 Sterile Processing Systems and Accessories: U.S. Healthcare Facilities Should Begin Plans for Transition to Acceptable Alternatives (Update)" and the "Reprocessing Alternatives for Flexible Endoscopes" matrix from ECRI Institute's Healthcare Product Comparison System(TM), are available for free (with registration) at https://www.ecri.org/Forms/Pages/STERIS-System-1-(SS1)-Replacement.aspx.

Alerts are issued weekly in Health Devices Alerts(TM), a component of membership in ECRI Institute's Health Devices System, Health Devices Gold(TM), and SELECTplus(TM) programs. Each alert includes a priority level, problem summary, perspectives, and recommendations for responding to the problem.