WebMD News from HealthDay
March 5, 2015 -- Four patients at Cedars-Sinai Medical Center in Los Angeles were sickened by a "superbug" that has been linked to a type of medical scope, the Los Angeles-based hospital said Wednesday.
Just two weeks ago, Ronald Regan UCLA Medical Center in Los Angeles announced that seven patients were infected with the superbug after undergoing endoscopic procedures. Two died.
The news from Cedars-Sinai came the same day as ABC News reported that the U.S. Food and Drug Administration said the endoscopes linked to the superbug infections at UCLA had been redesigned by the maker and were sold without approval.
In total, 179 patients may have been exposed to the CRE superbug at UCLA, according to the hospital.
Those cases were traced to two duodenoscopes, which are inserted into the mouth to access patients' small intestine, pancreas and liver. The scopes had only been in use since June and were cleaned according to manufacturer guidelines, hospital officials said.
Both scopes were made by Olympus Corp. The FDA says Olympus changed the design of the scopes and sold them without seeking permission to do so, ABC News reported.
Companies must notify the FDA of design changes 90 days before marketing redesigned devices, the FDA website says.
The FDA did not clarify what changes were made to the scopes or whether they could have increased the chances the scopes would be more difficult to clean or more likely to harbor bacteria, ABC News reported.
Officials at Cedars-Sinai said the hospital stopped all procedures using the endoscopes in question after learning about the UCLA outbreak and began its own investigation. The superbug may have been transmitted through a duodenoscope made by Olympus Corp., hospital officials said.
One patient died, but hospital officials said the cause was an underlying medical condition and not the superbug infection.
Cedars Sinai said that, as a precaution, it sent home-test kits to 71 patients who had procedures there to diagnose pancreatic and bile-duct problems.
source : 2nd Hospital Reports Superbug Linked to Endoscopes
