Managing Endoscopes

FDA Introduces Pilot Programs For EtO Sterilization Initiatives

The United States Food and Drug Administration (FDA) announced new initiatives to spur innovation in Ethylene Oxide (EtO) sterilization for medical devices. EtO has recently come under pressure as a practice due to the hazardous release of ethylene oxide into the environment from facilities performing the sterilization process. This year, the United States Environmental Protection […]

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FDA Clears First Duodenoscope With Disposable Elevator Component To Reduce Infection Risk

The United States Food and Drug Administration (FDA) has cleared the first duodenoscope on the market with a disposable elevator piece. The industry believes that a move to disposable parts, like the elevator, will help reduce infection risks. The elevators of duodenoscopes have been identified in numerous instances as a difficult to clean component that

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FDA Discussion Of Duodenoscopes Points To Several Causes For Safety Issues

The United States Food and Drug Administration (FDA) recently held a panel discussion to review the causes and possible solutions to safety issues arising from the use of duodenoscopes. Participants in the FDA’s General Hospital and Personal Use Panel of the Medical Devices Advisory Committee discussed how particular aspects of duodenoscopes have led to recent

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How Community Hospitals and ASCs Can Keep Up With Endoscope Documentation Requirements

When community hospitals and ambulatory surgery centers (ASCs) are visited by accreditation agencies like The Joint Commission (TJC) or DNV, they are held to the same strict endoscope documentation requirements as academic medical centers. While it may seem unfair for these smaller facilities with access to fewer resources to be held to the same strict

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How To Determine When To Sterilize Flexible Endoscopes

As the major endoscope manufacturers continue to work with regulators such as The United States Food and Drug Administration (FDA) to improve the safety of their endoscopes, many possible long-term solutions have been raised for discussion. Some thought leaders say that improving current high-level disinfection (HLD) processes will improve safety significantly, while many other experts

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ECRI Top Health Technology Hazards List Includes Poor Sterilization Practices

The ECRI Institute, based in Philadelphia, has just released its annual list of health technology hazards for 2020.  This year’s list includes an entry at number 3 for poor sterilization practices, echoing prior year concerns about sub-standard disinfection practices for flexible endoscopes. ECRI’s list is the result of extensive research by its own engineers, scientists

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A Scope Tracking Solution That Can Grow With Your Hospital

The Joint Commission (TJC), the United States Food & Drug Administration (FDA) and several other regulatory and accreditation agencies have recently put more focus on flexible endoscopes in their guidance to US hospitals and surgery centers. It comes as no surprise, as over the last decade the number of reported outbreaks based on inadequately reprocessed

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Why Channel Drying Is So Crucial To Endoscope Infection Control

Because endoscopes are reusable medical instruments, one of their biggest risks is the very real possibility of passing diseases to patients through contact with inadequately disinfected scopes. Though the risk of passing diseases through scopes is relatively low, the danger is always there, especially when high-level disinfection (HLD) protocols aren’t closely followed. One area where

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How To Reduce Unnecessary Contact With Endoscopes Using RFID Technology

One of the biggest risks of using flexible endoscopes in healthcare stems from the reusable nature of the expensive instruments. Though the risk of passing disease on through endoscopes is relatively low, the danger is always there even when following the instructions for use provided by the manufacturers. The high-level disinfection process for medical endoscopes

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FDA Presses Industry To Use Duodenoscopes With Disposable Components

The United States Food and Drug Administration (FDA) has begun its effort to move the US healthcare industry to use duodenoscopes with disposable components, such as end caps. The effort is being made to reduce the incidences of superbug transmissions through inadequately reprocessed duodenoscopes that have been reported in recent years. The FDA is urging

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