Endoscopes: Overcoming Design, Use, and Reprocessing Challenges

Endoscopes facilitate minimally invasive, lifesaving procedures that are critical to diagnosing and treating severe disease. Commonly used endoscopes include bronchoscopes, which are used for examining airways, and duodenoscopes, which are used for assessing diseases of the pancreas and bile ducts.

Although most endoscopic procedures are performed without complications, these potentially life-saving instruments carry the risk of infection if not designed, used, or cleaned and disinfected (reprocessed) properly. The many small, reusable components of these devices can be challenging to reprocess using automated endoscope reprocessors (AERs). If the reprocessing is not performed according to the manufacturer’s instructions—and even if medical professionals use the device correctly and follow the manufacturer’s instructions—endoscopes can remain contaminated after cleaning and high-level disinfection. While disposable (single-use) endoscopes appear to offer a solution to the problem of reprocessing, acquiring U.S. Food and Drug Administration (FDA) approval for these devices can be challenging.

Our team can help clients navigate these challenges throughout the medical device life cycle, from pre-market development through the regulatory submission process and post-market activity. Drawing from experience in fields such as biomedical engineering, human factors, epidemiology, microbiology, regulatory affairs, and medicine, we offer expertise in all aspects of pre-market design testing and development, including material selection and development of innovative designs to improve or eliminate reprocessing.
To assist companies that are considering adopting these new technologies, we offer health economics analyses to enable clients to weigh technology costs and savings, and we provide post-market support through surveillance and monitoring studies to better understand how endoscopes are reprocessed in real-world settings. To improve stakeholders’ reprocessing instructions and labeling, we offer human factors testing to improve users’ understanding of instructions for using, cleaning, and disinfecting their devices. We also help to evaluate the incidence and risk of adverse events, including infection, by examining the distribution and patterns of disease and their potential causes.

Exponent’s medical device development team offers the following services:

• Safety signal identification and adverse event evaluations

• Preparation of robust FDA and EU regulatory submissions and pre- and post-market regulatory strategies

• Risk assessment support based on post-market surveillance data analytics, human factors failure modes and effects analysis (FMEA)/usability hazards, root-cause analysis, fault tree analysis (FTA), and other approaches

• Integration of multi-modal approaches for collecting behavioral, psychological, and physiological measures to support the design phase

• Design of device labeling, including instructions for use (IFU) and warnings and caution statements

• Human factors formative and validation testing, including simulated-use studies and labeling comprehension studies

• Development support, creating robust and relevant preclinical verification and validation testing that considers the interaction of device user groups, use environments, use scenarios, and user interfaces

• Risk management planning and documentation of human factors/usability engineering testing for inclusion in design history file

• Product liability and risk mitigation analysis (design, labeling/IFU)

• Causal analysis of adverse events, including randomized controlled trials, post-market observational studies, and other epidemiologic data, as well as case reports and spontaneous adverse event reports.

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