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Device design is a key factor that contributes to reprocessing challenges.


Duodenoscope manufacturers have developed transition pro- grams to move to fully disposable duodenoscopes and those with disposable components:


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The Olympus TJF-180V duodenoscope is recalled due to dete- rioration of the adhesive which may pose a risk of endoscope contamination due to ineffective reprocessing or fluid invasion contaminated endoscope can present an infection risk to patients. Olympus America is offering customers with the older generation TJF-Q180V scopes a direct, no-cost 1 for 1 replacement with the TJF-Q190V. enta is withdrawing - and -i. he uifilm fied endcap duodenoscope - has been withdrawn. To date, the FDA has cleared seven duodenoscopes with dispos-


able components that facilitate reprocessing or are fully disposable: Fully Disposable:


•Ambu Innovation GmbH, Duodenoscope model aScope Duo- deno fully disposable duodenoscope cleared under  oston cientific orporation,  odel  ingle-se uodenoscope fully disposable duodenoscope cleared under 


isposable omponents uifilm orporation, uodenoscope model - disposable endcap duodenoscope cleared under  lympus edical ystems, vis era  uodenovideo- scope lympus J- disposable endcap duodeno- scope cleared under  enta edical, uodenoscope model -i dispos- able elevator duodenoscope cleared under  and  enta edical, uodenoscope model -i disposable elevator duodenoscope cleared under  o onger arketed enta edical, uodenoscope model -i disposable endcap duodenoscope cleared under  and  Reprocessing Duodenoscopes:


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Results from the Postmarket Surveillance Studies: n , each manufacturer of reusable duodenoscopes uifilm, lympus and enta currently marketing in the .. was ordered by the FDA to conduct postmarket surveillance studies to deter- mine rates of contamination after clinical use and reprocessing of its fied endcap duodenoscopes. ied endcap duodenoscopes have a plastic or rubber cap permanently glued to the metal edges around the distal end to prevent tissue injury from the metal edges on the scopes, but when permanently affied, the endcaps also limit the accessibility to clean the crevices at the distal end. In , the  also issued postmarket surveillance study orders to manufacturers of duodenoscopes with disposable endcaps to gather more information and verify that the new designs reduce the contamination rate.


The postmarket surveillance studies are intended to determine the real-world contamination rates for duodenoscopes in clinical use and serve as measures of the effectiveness of reprocessing. FDA previously communicated interim study results demonstrating higher than expected levels of contamination.


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©  


he final results of the postmarket surveillance studies on fied endcap design indicate that as high as . of samples tested posi- tive with high concern organisms after contamination. High concern organisms are defined as organisms that are more often associated with disease, such as E. coli, and Pseudomonas contamination after reprocessing. As a result, Pentax and Olympus are withdrawing their fied endcap duodenoscopes from the market, and uifilm has completed withdrawal of its fied endcap duodenoscope. HPN


8 May 2022 • HEALTHCARE PURCHASING NEWS • hpnonline.com 2205HPN_CIVCOMedicalSolutions.indd 1 3/23/22 3:59 PM


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