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 medical device reports describe both patient infections and other possible contamination issues.
Minimally invasive surgical endoscopes can tackle both the challenges of cost as well as durability.
Hackers and their ability to access systems remotely and disrupt healthcare organizations are a key concern.
Reusable devices have become more difficult to clean, disinfect and sterilize. FDA is now requiring clear instructions for effective reprocessing.
The agency released a guidance document with product design recommendations to help prevent contamination from device components.
With the consent decree, the risk of financial death is very real.
Complexity of design and frequency of use play a large role in how effectively scopes are reprocessed.
ECRI’s top 10 hazards list drew attention to technology issues, and device manufacturers should be communicating with hospitals to address the problems.
ECRI’s annual list points the finger at poor cleaning of flexible endoscopes.