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FDA Issues Stricter Guidelines to Endoscope Manufacturers Following the Deaths of Two Patients Infected with Antibiotic-Resistant Bacteria

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FDA Issues Stricter Guidelines to Endoscope Manufacturers

FDA Issues Stricter Guidelines to Endoscope Manufacturers


Outbreaks of a deadly superbug caused by lingering bacteria on duodenoscopes have triggered federal health officials to issue stricter guidelines for manufacturers that are intended to ensure the devices are sufficiently disinfected.

The guidelines not only apply to the scopes, but to reusable medical instruments, in general.  The U.S. Food and Drug Administration (FDA) will ask duodenoscope manufacturers to submit scientific data showing that their devices can be adequately disinfected. FDA officials have admitted that the agency’s previous guidelines from 1996 made no such request from manufacturers, according to the Associated Press (AP).

Dr. Stephen Ostroff, the FDA’s chief scientist, told the AP that the agency hastened to write new guidelines because of the recent outbreaks. After spending several years working on new guidelines, the FDA finally issued a drafted version of them in 2011, but the agency’s action stopped there. Two Los Angeles hospitals have grappled with deadly superbug outbreaks in recent weeks, including Ronald Reagan UCLA Medical Center, where seven patients who underwent endoscopic procedures using duodenoscopes manufactured by Olympus Corp. contracted an antibiotic-resistant strain of bacteria. Two patients died. Cedars-Sinai Medical Center officials announced last week that four patients were infected with the same bacteria after undergoing endoscopic procedures using the same Olympus duodenoscope.

The FDA originally responded by recommending that hospitals follow manufacturers’ instructions for disinfecting the duodenoscopes, but the agency acknowledged that those procedures alone may not disinfect the scopes. The FDA said Thursday they are trying to determine how the devices’ design could be improved, but stressed that the agency could not force manufacturers to redesign the scopes. Outside experts say that it would be years before redesigned duodenoscopes reached the market, the AP reported.

“Unfortunately, it’s going to take manufacturers some time to design a different way to do this,” Chris Lavanchy, engineering director at the ECRI Institute, which studies medical product issues, explained to the AP. “And then it’s going to take the FDA time to confirm that it’s a safer approach.”

Some hospitals have started sterilizing scopes with toxic ethylene oxide gas, while others have taken to quarantining the scopes after use and performing laboratory testing to identify any dangerous bacteria. Experts say that regularly culturing the scopes would require U.S. hospitals it expand their inventory of duodenoscopes in order to cycle the devices in and out of use. The devices themselves cost about $40,000 a piece, the AP reported.

are taking extra steps to try and disinfect the scopes, including sterilizing scopes with ethylene oxide gas, which can be toxic to both patients and clinicians. Some hospitals have also been quarantining the duodenoscopes after use and performing laboratory testing to identify any dangerous bacteria, according to the AP.

breakinglawsuitnews.com disclaimer: This article: FDA Issues Stricter Guidelines to Endoscope Manufacturers Following the Deaths of Two Patients Infected with Antibiotic-Resistant Bacteria was posted on Friday, March 13th, 2015 at 2:56 pm at breakinglawsuitnews.com and is filed under Medical Device Lawsuits.

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