Olympus Gets Another FDA Warning Letter for Failing to Address Duodenoscope Complaints
The FDA has issued another warning letter to Olympus Medical, indicating the company has ignored complaints over problems with its duodenoscopes.
The FDA has issued another warning letter to Olympus Medical, indicating the company has ignored complaints over problems with its duodenoscopes.
A new study appears to confirm the effectiveness of disposable elevator caps in preventing duodenoscopes from passing infections from one patient to another.
The FDA has issued warning letters to Olympus over a failure to meet quality control requirements, including reporting of complaints, involving its endoscope products.
The FDA says disposable duodenoscopes should be adopted by every hospital in the U.S. to cut down on infection risks linked to the endoscopic devices.
The FDA warns that instructions for cleaning dozens of models of Karl Storz urological endoscopes is insufficient, and could leave patients vulnerable to infections.
The FDA is warning that certain urological endoscopes have been linked to hundreds of infections and several deaths in recent years.
The FDA has issued a new draft guidance on how arthroscopy tubing sets can be designed to prevent transfer of infectious materials between patients.
The FDA urges hospitals to start using duodenoscopes that are fully disposable or use disposable parts to protect their patients from potential infections.
The FDA has approved the first fully disposable duodenoscope in an effort to eliminate the risk of infections linked to ineffective sterilization techniques.
The FDA has approved the first duodenoscope with a disposable elevator tip, which should reduce infection risks.