Publications

Technology Assessment of Single-Use Flexible Endoscopes

Lecture, Dr Kenneth Binmoeller, Cedars-Sinai International Endoscopy Symposium, February 1, 2020, Los Angeles, CA

Debate: "Is it wise to use one-time-use duodenoscopes? YES, IT IS"

A status evaluation report on the current state of Cholangiopancreatoscopy. 2016

Cholangiopancreatoscopy

Single-use ureteroscopes have been gaining popularity in recent years. We compare the optics, deflection, and irrigation flow of two novel single-use flexible ureteroscopes with contemporary reusable and single-use flexible ureteroscopes.
Next-Generation Single-Use Ureteroscopes: An In Vitro Comparison

Durability Data and Costs

Handling and protecting your flexible ureteroscope: how to maximise scope usage

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Business Analysis of Single-Use Flexible Endoscopes

Isiris α (Coloplast®) is an innovative single-use disposable flexible cystoscope with an integrated ureteric stent grasper designed specifically to remove ureteric stents. It allows clinicians to remove ureteric stents easily on the wards or in clinics without the need of arranging a routine and dedicated flexible cystoscopy appointment for patients. We evaluated Isiris α’s practical use and cost analysis against traditional reusable endoscopes.

Cost Analysis and Service Delivery On Using Isiris a™ To Remove Stents

Multiple studies have documented a high rate of contaminated colonoscopes after repro- cessing. Contaminated reusable colonoscopes may increase the risk of device-related patient infections. As disposable colonoscopes enter the market, they may play a role in infection preven- tion and may be cost-effective at some facilities or in high-risk patients. Using a micro-costing approach, this study found that the cost per colonoscopy including purchase, maintenance and reprocessing ranges from US$188.64 at high volume centres (3000 annual procedures) to US$501.16 at low volume centres (1000 annual procedures).

The hidden cost of colonoscopy including cost of reprocessing and infection rate: the implications for disposable colonoscopes

Editorial by Mihai Ciocîrlan

Low-cost disposable endoscope: pros and cons

In the face of outbreaks, consistent problems with high-level disinfection, and design flaws, duodenoscopes have been a hot topic in infection control and public health. Increasingly, the potential for single-use, disposable options have been promoted as a way to reduce risk to patients.

Duodenoscopes: A Complicated History Manufactures a Hopeful Future

Questions and Answers: Endoscopy-related infection prevention and control 

Hospital Infection Control: Endoscopy

Cost/Performance Analysis

Concept of disposable duodenoscope: at what cost?

The Centers for Medicare & Medicaid Services (CMS) has released a new device pass-through code (C1748) for single-use endoscopes, for example the EXALTTM Model D Single- Use Duodenoscope. This code is specific to the single-use technology and not the specific model.

New Medicare Pass-Through Code for Single-Use Endoscopes

Medicare Claims Processing

July 2020 Update of the Hospital Outpatient Prospective Payment System (OPPS)

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FDA Communications Regarding Flexible Endoscopy

The FDA is providing interim results from the ongoing mandated postmarket surveillance studies (“522 study”) (Click here) to inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after reprocessing. Facilities and staff that reprocess duodenoscopes are reminded of the importance of manual cleaning prior to disinfection or sterilization and proper servicing of duodenoscopes. - December 10, 2018

The FDA Provides Interim Results of Duodenoscope Reprocessing Studies Conducted in Real-World Settings: FDA Safety Communication

Update as of April 10, 2020: The FDA continues to recommend that hospitals and endoscopy facilities transition to innovative duodenoscope designs to help improve cleaning and reduce contamination between patients, including designs with disposable caps or distal ends. - August 4, 2015

The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication

FDA is providing a detailed list of supplemental duodenoscope reprocessing measures that emerged from an agency-led expert panel meeting earlier this year. Hospitals and health care facilities that utilize duodenoscopes can, in addition to meticulously following manufacturer reprocessing instructions, take one or more of these additional steps to further reduce the risk of infection and increase the safety of these medical devices.

Supplemental Measures to Enhance Duodenoscope Reprocessing: FDA Safety Communication

Updated Information for Health care Providers Regarding Duodenoscopes. 
March 4, 2015

Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes: FDA Safety Communication

The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it. 

March 4, 2015

Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

Background and FDA's Ongoing Activities

Infections Associated with Reprocessed Duodenoscopes

FDA Executive Summary: Prepared for the November 6-7, 2019 meeting of the General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee

Reducing the Risk of Infection from Reprocessed Duodenoscopes

The U.S. Food and Drug Administration today issued warning letters to all three duodenoscope manufacturers for failing to comply with requirements of federal law under which they were ordered to conduct postmarket surveillance studies to assess the effectiveness of reprocessing the devices. - March 09, 2018

FDA warns duodenoscope manufacturers about failure to comply with required postmarket surveillance studies to assess contamination risk

The Food and Drug Administration (FDA) has issued a communication to healthcare professionals to share preliminary information regarding infections associated with the use of reprocessed flexible bronchoscopes. - September 18, 2015

FDA Issues Alert on Infections Associated with Reprocessed Flexible Bronchoscopes

Device design,  Reprocessing methodology , Methods for validating the cleaning and high-level disinfection and sterilization instructions

Factors Affecting Quality of Reprocessing

Duodenoscope Surveillance Sampling & Culturing Protocols

Duodenoscope Surveillance Sampling & Culturing: Reducing the Risks of Infection

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Clinical Observations Associated with Flexible Endoscopy

Inadequately disinfected endoscopes are implicated in 44 cases.

Physician Induced CRE Infections

Endoscopy, Duodenoscope design , Reprocessing, Multidrug-resistant organisms (MDRO), Infection control

Hygiene: The Looming Achilles Heel in Endoscopy

Johns Hopkins study finds some outpatient centers have infection risks 100 times higher than expected.

Infection Rates After Colonoscopy, Endoscopy at US Specialty Centers Are Far Higher Than Previously Thought

Flexible endoscopes are widely used to examine, diagnose, and treat medical disorders. While the risk of endoscopy-related transmission of infection is estimated to be very low, more health care-associated infections are related to contaminated endoscopes than to any other medical device. Flexible endoscopes can get highly contaminated with microorganisms, secretions and blood during use. The narrow lumens and multiple internal channels make the cleaning of flexible en- doscopes a complex and difficult task.

Infectious diseases linked to cross-contamination of flexible endoscopes

Increasing numbers of outbreaks caused by contaminated duodenoscopes used for endoscopic retrograde cholangiopancreatography (ercP) procedures have been reported, some with fatal outcomes. We conducted a nationwide cross-sectional study to determine the prevalence of bacterial contamination of reprocessed duodenoscopes in the Netherlands.
High prevalence rate of digestive tract bacteria in duodenoscopes: a nationwide study

Springfield, Massachusetts-based Baystate Medical Center is notifying nearly 50 patients that a recent colonoscope procedure may have exposed them to a life-threatening illness. The news was reported by Masslive.com, and continues the trend of endoscope-related safety issues across the US.

Massachusetts-Based Hospital The Latest To Reveal Endoscope-Related Infection Risk

Most cases of microbial transmission to patients via contaminated endoscopes have resulted from nonadherence to reprocessing guidelines. We evaluated the occurrence, features, and implications of reprocessing lapses to gauge the nature and breadth of the problem in the context of widely available and accepted practice guidelines.

Reported gastrointestinal endoscope reprocessing lapses: The tip of the iceberg

Insufficient cleaning efforts pave path for single-use endoscopes

Renewed Scope Cleaning Efforts Not Enough to Vanquish Bacteria

Overview of the infections and cross-contaminations related to flexible gastrointestinal endoscopy and bronchoscopy and illustrates the impact of biofilm on endoscope reprocessing and postendoscopic infection.

Transmission of Infection by Flexible Gastrointestinal Endoscopy and Bronchoscopy

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Disclaimer: Flexible endoscopes are 510k Class II per the Medical Device Amendments of 1976 to the Federal Food, Drug and Cosmetic Act and subject to all current the Food and Drug Administration (FDA) regulations. The flexible endoscopes (Devices) disclosed on this website are in various stages of development and submission to the FDA. The Devices disclosed are neither cleared by the FDA for sale nor offered for sale by AdaptivEndo™, LLC.

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