The United States Food & Drug Administration (FDA) recalled a specific type of breast implant manufactured by Allergan. The recall, announced earlier in 2019, included the textured Biocell breast implants and expanders. The implants have been linked to a certain cancer, called BIA-ALCL. While the exact link between these implants and the cancer is unknown, […]
FDA Recalls Allergan Textured Breast Implants Read More »
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
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
FDA Discussion Of Duodenoscopes Points To Several Causes For Safety Issues Read More »
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
How Community Hospitals and ASCs Can Keep Up With Endoscope Documentation Requirements Read More »
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
How To Determine When To Sterilize Flexible Endoscopes Read More »
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
ECRI Top Health Technology Hazards List Includes Poor Sterilization Practices Read More »
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
A Scope Tracking Solution That Can Grow With Your Hospital Read More »
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
Why Channel Drying Is So Crucial To Endoscope Infection Control Read More »
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
How To Reduce Unnecessary Contact With Endoscopes Using RFID Technology Read More »
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
FDA Presses Industry To Use Duodenoscopes With Disposable Components Read More »