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Posts tagged "#duodenoscope"

FDA demands endoscope recall

Impelled by reported infections spread by contaminated intestinal probes, the U.S. Food and Drug Administration on Friday cracked down on the maker of devices used to clean the instruments between insertions into patients' bodies. The FDA ordered Custom Ultrasonics to recall all of its automated endoscope re-processors, or AERs, from health care facilities due to regulatory infractions that the agency said in a statement "could result in an increased risk of infection transmission."

FDA demands endoscope recall

Impelled by reported infections spread by contaminated intestinal probes, the U.S. Food and Drug Administration on Friday cracked down on the maker of devices used to clean the instruments between insertions into patients' bodies. The FDA ordered Custom Ultrasonics to recall all of its automated endoscope re-processors, or AERs, from health care facilities due to regulatory infractions that the agency said in a statement "could result in an increased risk of infection transmission."

Believe it: more suspected duodenoscope 'superbugs'

Bacteria-resistant infections potentially connected to procedures involving the reusable duodenoscope have been reported across the country, notably in Southern California, where reportedly three infected patients died. If manufacturers and federal officials had thought they had contained the problem, they were mistaken, as another hospital announced Wednesday that some of its patients developed a suspected duodenoscope-related infection.

Believe it: more suspected duodenoscope 'superbugs'

Bacteria-resistant infections potentially connected to procedures involving the reusable duodenoscope have been reported across the country, notably in Southern California, where reportedly three infected patients died. If manufacturers and federal officials had thought they had contained the problem, they were mistaken, as another hospital announced Wednesday that some of its patients developed a suspected duodenoscope-related infection.

FDA issues new 'scope' superbug prevention procedures

The use of the duodenoscope, which is used to examine a part of the small intestine, has been linked to the outbreak of drug-resistant so-called "superbugs" at hospitals in Los Angeles and elsewhere in the U.S. While some of the victims have filed product liability lawsuits against one of the device's leading manufacturers, the U.S. Food and Drug Administration has issued a new list of measures intended to clean the device between uses.

FDA issues new 'scope' superbug prevention procedures

The use of the duodenoscope, which is used to examine a part of the small intestine, has been linked to the outbreak of drug-resistant so-called "superbugs" at hospitals in Los Angeles and elsewhere in the U.S. While some of the victims have filed product liability lawsuits against one of the device's leading manufacturers, the U.S. Food and Drug Administration has issued a new list of measures intended to clean the device between uses.

Medical scopes linked to serious superbugs

The makers of medical scopes that are used to evaluate and to treat problems in the bile and pancreatic ducts turned down invitations to speak at a medical device safety panel discussion that the U.S. Food and Drug Administration held May 14. Meanwhile, the FDA continues to investigate the link between the use of these reprocessed devices, known as duodenoscopes, and the emergence of potentially fatal superbugs.

Medical scopes linked to serious superbugs

The makers of medical scopes that are used to evaluate and to treat problems in the bile and pancreatic ducts turned down invitations to speak at a medical device safety panel discussion that the U.S. Food and Drug Administration held May 14. Meanwhile, the FDA continues to investigate the link between the use of these reprocessed devices, known as duodenoscopes, and the emergence of potentially fatal superbugs.

FDA issues new anti-infection duodenoscopes guidance

Reacting to the association between the use of duodenoscopes and some patients' development of drug-resistant infections, the U.S. Food and Drug Administration issued new industry recommendations March 12 aimed at helping manufacturers to develop safer reusable medical devices.

FDA issues new anti-infection duodenoscopes guidance

Reacting to the association between the use of duodenoscopes and some patients' development of drug-resistant infections, the U.S. Food and Drug Administration issued new industry recommendations March 12 aimed at helping manufacturers to develop safer reusable medical devices.

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