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TSO3 ISSUES STATEMENT ON WEBSITE RE: FDA PR

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FDA Finds Higher Than Expected Contamination Rates in Duodenoscopes; STERIZONE® VP4 Sterilizer A Solution to This Priority Issue

On December 10, 2018, the FDA issued a Safety Communication including Interim Results ofDuodenoscope Reprocessing Studies (“Interim Results”). In the Interim Results, the FDA raised concerns that although the post-market surveillance studies for duodenoscopes were at least 10% complete, the data showed contamination rates much higher than expected. The studies were designed assuming less than a 0.4% contamination rate, but the actual rates are up to 3%of samples testing positive for “low concern organisms” and up to 3% of samples testing positivefor “high concern organisms” (including E. coli, Staphylococcus aureus and Pseudomonas aeruginosa). Click here to read the Interim Results.

Recent independent, peer-reviewed published studies have indicated contamination rates for endoscopes greater than 60% (Ofstead CL, et al. Am J Infect Control. 2017 Feb 1;45(2):e26-e33; Ofstead CL, et al. Am J Infect Control. 2017 Aug 1;45(8):888-895). In addition, the risk of infection from endoscopy was found to be much higher than previous reports indicated (Wang P, et al. Gut 2018;0:1–11).

The FDA also stated in the Interim Results that the reprocessing instructions for healthcare providers provided by the endoscope manufacturers are difficult to comprehend and follow. Jeff Shuren, M.D., J.D., Director of the Center for Devices and Radiological Health stated: “It hasbecome clear that following the manufacturer’s reprocessing and maintenanceinstructions, while critical, is not sufficient to avoid all infections associated with the use of duodenoscopes.” Click here to read his statement.

The FDA noted that they will continue to encourage the development of new technology to enhance patient safety for Endoscopic Retrograde Cholangiopancreatography or ERCP procedures where a duodenoscope is used. TSO3’s investment in its STERIZONE technology has been timely and provides one solution to this critical unmet medical need. With the FDA clearance of the STERIZONE VP4 Sterilizer to sterilize long, multi-channel flexible endoscopes including duodenoscopes in May 2018, the Company is the first and only sterilizer that has been cleared and validated to terminally sterilize these instruments. Sterilization of duodenoscopes with the STERIZONE VP4 Sterilizer provides an increased level of safety for patients right now while endoscope manufacturers work to modify reprocessing instructions and improve endoscope design.

In the Interim Results, the FDA urges patients to discuss this risk of infection with their healthcare professional before undergoing an ERCP procedure.

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Carla Warner of North Carolina knows the devastating impact that Carbapenem-resistant Enterobacteriaceae (CRE), an antibiotic resistant infection, had on her husband, who contracted the infection following an ERCP procedure and died. Click here to hear more of Warner’s story. As recently as June 2018, infections believed to be transmitted via a duodenoscope were reportedto the FDA through FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database.

Failure to consistently and effectively reprocess flexible endoscopes is listed second on the Top 10 Health Technology Hazards for 2018 published by the ECRI Institute, and has been in the top 10 list for several years. Gastroenterology & Endoscopy News recently launched a new “Priority Report” on Endoscope Reprocessing and Infection Control. Click here for the inaugural issue.

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Several healthcare facilities in the US and Canada have been sterilizing duodenoscopes with the STERIZONE VP4 Sterilizer, including Vancouver General Hospital, Htel du Qubec and Altru Health, and additional health systems are expected to add duodenoscopes to the instruments sterilized in the STERIZONE VP4 Sterilizer. Click here for statement from Jenni Gibbs, Manager, Central Sterile Department, Altru Health. If you are a healthcare facility interested in information on the STERIZONE VP4 Sterilizer, please call 1-866-895-4734 or send an email [e-mail].

About Duodenoscopes and ERCP

Duodenoscopes are flexible endoscopes used in a procedure called an Endoscopic Retrograde Cholangiopancreatography or ERCP, which enables a physician to perform diagnostic and therapeutic procedures involving a patient’s gallbladder, common bile duct, pancreas and liver.Approximately 500,000 ERCP procedures are performed each year in the United States. Antibiotic-resistant infections that resulted in life-threatening infections and deaths have recently been linked to the improper reprocessing of duodenoscopes.

© TSO3, Inc. All rights reserved in all countries. TSO3 and STERIZONE are registered trademarks of TSO3, Inc. Version Date: December 13, 2018