Following Karl Storz’s recall of urological endoscopes, the agency wants to make sure that healthcare providers have seen the company’s urgent labeling update involving sterilization methods.
The COVID-19 pandemic has changed hospital processes and made people more aware of the need to thoroughly sterilize medical instruments between patients. This article discusses some of the changes that may occur due to lessons learned throughout the global health emergency.
The medical device reports describe both patient infections and other possible contamination issues.
To avoid delays in timelines, companies should develop IFU cleaning instructions with the worst-case clinical use and contamination method in mind.
COVID-19 requires us to rethink our current device disinfection procedure.
During an outbreak, it is critical to treat reusable medical devices as potential sources of transmission.
The company developed the device as an alternative to reusable duodenoscopes, enabling the use of a new and sterile product for each procedure.
CooperVision, Inc. and Pentax of America won the agency approvals, respectively.
The agency wants healthcare facilities to start using duodenoscopes that do not require reprocessing but recognizes the transition will take time.
Minimally invasive surgical endoscopes can tackle both the challenges of cost as well as durability.