80°
Baton Rouge, Louisiana
7 Day Forecast
Follow our weather team on social media

FDA: scope manufacturer waited years to report problems

2 years 2 months 1 day ago Monday, August 17 2015 Aug 17, 2015 August 17, 2015 10:34 AM August 17, 2015 in Health
Source: Associated Press
By: APNewsNow

WASHINGTON - Federal regulators have uncovered new violations by the manufacturer of medical scopes recently linked to outbreaks of deadly "superbug" bacteria at U.S. hospitals.

Olympus Corp. failed to alert regulators to a cluster of 16 infections in patients who underwent procedures with the company's scope in 2012, according to a warning letter issued Monday by the Food and Drug Administration. Olympus did not report the problems to the FDA until 2015, when the company was already under scrutiny for a more recent series of outbreaks. 

Additionally, FDA inspectors say that the company has no procedure for promptly reporting serious problems with its devices, a requirement for medical device makers.

Olympus medical scopes were linked to infections of antibiotic-resistant bacteria at two separate Los Angeles hospitals early this year.

More News

Desktop News

Click to open Continuous News in a sidebar that updates in real-time.
Radar
7 Days