Navigation Links
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 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.

For more information about ECRI Institute's medical device membership resources, please visit www.ecri.org, or contact us by phone at (610) 825-6000, x5891, by e-mail at clientservices@ecri.org, or by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462.

About ECRI Institute

ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research to healthcare to uncover the best approaches to improving patient care. As pioneers in this science for over 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. ECRI Institute is designated a Collaborating Center of the World Health Organization and an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI Institute PSO, listed as a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services, strives to achieve the highest levels of safety and quality in healthcare by collecting and analyzing patient safety information and sharing lessons learned and best practices. For more information, please visit www.ecri.org.


    For more information, contact:
    Laurie D. Menyo
    (610) 825-6000, ext. 5310
    lmenyo@ecri.org

SOURCE ECRI Institute


'/>"/>
SOURCE ECRI Institute
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. SRI International Receives National Institutes of Health Grants to Develop Improved Tomographic Imaging Technology
2. Van Andel Institute Cuts Ribbon on $178 Million Expansion
3. Laser Spine Institute Partners with United Healthcare
4. Pharmaceutical Institute Launches New Training Resource Focused on the Hospital Marketplace
5. ECRI Institute Releases Roadmap to the Evidence on Finasteride for Prevention of Prostate Cancer: New Hotline Report to Aid Healthcare Decision Makers and Journalists
6. Karmanos Cancer Institute Launches Company and Innovative Breast Imaging Tool
7. Royal Institute of Technology Adopts OriGene Over-Expression Lysates in Human Proteome Atlas Program
8. Celling Technologies Signs Exclusive Agreement to Research and Develop Adipose Tissue Stem Cell Technology in Regenerative Medicine Institutes
9. Texas Cardiac Arrhythmia Institute at St. Davids Medical Center First in the United States to Utilize Newly FDA-Cleared CARTO(R) 3 Navigation System
10. Trana Discovery and Southern Research Institute Find Bioactive HIV Antiviral Compounds
11. Is Poor Medical Equipment Planning Costing your Healthcare Project Wasted Dollars and Delays? ECRI Institute outlines best practices to ensure better outcomes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/4/2016)... , Feb. 4, 2016 Worldwide Radiology ... significant growth as next generation systems provide a ... radiology for cancer surgery. New systems pinpoint the ... that has been such a problem previously, limiting ... Radiosurgery robots take cancer surgery far beyond what ...
(Date:2/4/2016)... LONDON , Feb. 4, 2016 ... Summary Global Markets Direct,s, ,Wegener Polyangiitis - ... the Wegener Polyangiitis,s therapeutic pipeline. This report ... Wegener Polyangiitis, complete with comparative analysis at various ... action (MoA), route of administration (RoA) and molecule ...
(Date:2/4/2016)... , Feb. 4, 2016 Global ... competitive market to drive long-term market growth ... common set of chronic disorders that affect 5–7% ... in terms of their symptoms and key patient ... dysregulation of immune pathways and an inappropriate immune ...
Breaking Medicine Technology:
(Date:2/6/2016)... ... 2016 , ... Research has shown that building shame resilience ... and level of relapse. , At the 2016 iaedp Symposium, the ... the critical tasks of the recovery phase and beyond including relapse prevention and ...
(Date:2/5/2016)... , ... February 05, 2016 , ... ... availability of the company's lighter, sleeker next generation LYNX VR Indoor Trainer with ... , Improvements in design and manufacturing not only reduce the weight of the ...
(Date:2/5/2016)... ... , ... The event is being held on April 7, 2016 from 5:30 ... Over Parkinson’s will fund nearly $100,000 for research for the care and cure of ... and is the architect of this informative event to raise awareness and funds for ...
(Date:2/5/2016)... ... February 05, 2016 , ... Looking for a last-minute Valentine’s Day ... tips of your toes. Foot massage, whether administered by a professional masseuse or a ... The American Board of Multiple Specialties in Podiatry (ABMSP) has taken the ...
(Date:2/5/2016)... Florida (PRWEB) , ... February 05, 2016 , ... ... non-profit organization devoted exclusively to funding innovative lymphoma research and serving the lymphoma ... – is poised to once again host, Swirl, A Wine Tasting Event at ...
Breaking Medicine News(10 mins):