Regulatory Compliance

Shortly following the recent United States Food and Drug Administration (FDA) clearance of the first duodenoscopes with disposable components, the bureau is now recommending that facilities move to the new models where available. The FDA firmly believes that a move to disposable parts, and in some cases fully disposable scopes, will help reduce infection risks. […]

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

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

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

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