Publications
Technology Assessment of Single-Use Flexible Endoscopes
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
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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
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
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
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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
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
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
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Clinical Observations Associated with Flexible Endoscopy
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