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FDA Hopes new Rules will Make Endoscopes Blamed on a Superbug Outbreak Cleaner and Safer

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FDA Hopes new Rules will Make Endoscopes Cleaner and Safer

FDA Hopes new Rules will Make Endoscopes Cleaner and Safer

Under new federal rules, endoscope manufacturers will need to prove to the U.S. Food and Drug Administration (FDA) that its devices can be thoroughly cleaned. The move comes on the heels of an outbreak of a superbug at two Los Angeles hospitals.

Duodenoscope manufacturers will now need to provide scientific evidence that duodenoscopes can be cleaned reliably, but the FDA cannot require manufacturers to change the design of the devices to make them easier to disinfect. The FDA said it was issuing new rules for cleaning the duodenscopes, along with a wide range of other reusable medical devices. The agency proposed the rules in draft form in 2011, but they were never finalized, the Los Angeles (LA Times) reported.

Some experts and patient-safety advocates have called for the scopes to be recalled, but the FDA declined to do so. The agency stood by their decision not to recall the duodenoscopes, even though they have been blamed for the spread of antibiotic-resistant bacteria known as carbapenem-resistant Enterobacteriaceae, or CRE, at Ronald Reagan UCLA Medical Center and Cedars-Sinai Medical Center, both in Los Angeles. Eleven people total were sickened at the hospitals, and two patients died. More than 200 patients were possibly exposed to the superbug. CRE kills up to 50 percent of those infected, according to the LA Times.

Medical experts and lawmakers alike have applauded the agency’s move, but question why it took the FDA so long to act, and wonder if even tougher measures may be needed, according to the LA Times.

“I continue to be concerned about why these infections occurred in the first place and whether there is more we can do to prevent them from happening again,” said Sen. Patty Murray, a Democrat from Washington.

Dr. Stephen Ostroff, the FDA’s chief scientist, said the agency had “accelerated” its work on the proposed rules after the recent outbreaks in Los Angeles. Ostroff said the agency had received 135 reports of patient infections linked to duodenscopes from January 2013 through December 2014. Some doctors, health officials and patient-safety experts say the actual number of scope-related infections may be higher because many cases have gone undetected and unreported, according to the LA Times.

“There are indications the infection rate is significantly underreported, and that calls into question the FDA’s conclusions and lack of action,” Lawrence Muscarella, a hospital-safety consultant in Montgomeryville, Pennsylvania, told the LA Times.

Olympus Corp., the maker of the scopes blamed for the infections at UCLA and Cedars-Sinai, along with Pentax Medical and Fujifilm were asked by the FDA in spring 2014 to submit test results showing that their devices could be fully disinfected. All three companies have failed twice to submit adequate data to the agency, according to the LA Times. disclaimer: This article: FDA Hopes new Rules will Make Endoscopes Blamed on a Superbug Outbreak Cleaner and Safer was posted on Friday, March 13th, 2015 at 2:57 pm at and is filed under Medical Device Lawsuits.

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