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New procedure for making medical devices safer

Back in February 2015, Digital Journalist Karen Graham reported on the deaths of two patients at a Los Angeles hospital (UCLA’s Ronald Reagan Medical Center.) The fatalities were linked to members of the bacterial group Carbapenem-resistant Enterobacteriaceae (CRE), which are resistant to one of the antibiotics of last resort. In addition to the deaths, over 179 additional patients were exposed to the antibiotic-resistant bacteria.

In a follow up report, Karen Graham raised the concern that the Olympus Corporation, the manufacturer of the endoscope involved in the two superbug deaths, did not obtain permission to sell the device. This led to criticism about the effectiveness of he jurisdiction provided by the U.S. Food and Drug Administration (FDA).

In an addendum to these two important investigative reports, Olympus America has issued new protocols for cleaning and disinfecting the medical instruments of concern: duodenoscopes. The instrument is a special an endoscope for examining the duodenum (the first section of the small intestine.)

The FDA, in the wake of criticisms, has issued a general warning that the devices can be difficult to disinfect between uses and “may facilitate the spread of deadly bacteria,” according to The Washington Post. The federal agency has been working with manufacturers of the devices in recent months to figure out more reliable ways to clean duodenoscopes and to examine potential design changes.

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Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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