Severe infections in hospital patients around the country have been attributed to unclean and unsterilized endoscopes used in surgeries and routine examinations. It is believed that more than 30 patients have died in the last three years as a direct result of endoscope infections. The Food and Drug Administration (FDA) is investigating the causes and consequences.
Unclean Clinic Conditions & Bad Practices
Federal regulators have found several instances of surgical teams failing to properly clean endoscopes and duodenoscopes after procedures. One medical center in Detroit allegedly did not enforce or follow basic cleaning routines and practices; inspectors witnessed one set of instruments being put away after being used without sterilization. There have also been cases where blood was mopped in the operating room without first clearing out equipment. The report raises concerns across the country of a general lack of oversight and due diligence in hospitals when it comes to properly cleaning medical utensils.
At least 12 hospitals were also cited for failing to report patient deaths or injuries linked to potentially-dangerous medical devices, such as infected endoscopes. Hospitals need to tell the FDA about such injuries or deaths within 10 days of the incident. Manufacturers that learn about an issue firsthand have 30 days to report it.
Endoscopes Dangers By Design
Not all of the blame for patient infections can be placed directly on medical practitioners and surgeons. In some cases, endoscopes have been designed defective, making it impossible to fully clean the device. Some endoscopes are also given to clinics without full instructions on how to sterilize them, forcing doctors to do their best guesswork. The end result is putting patients at risk of serious infections.
If you or a loved one have been seriously injured by an endoscope infection, the hospital or the endoscope manufacturer could be to blame. Contact Kaiser Gornick, LLP and our defective product attorneys in San Francisco. We also represent clients nationwide for defective medical device cases.