Tags: endoscopes | patient | infections | ucla | fda

FDA Took Years to Link Dirty Endoscopes to Patient Risks

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Thursday, 11 Feb 2016 02:54 PM

The U.S. Food and Drug Administration took years to decide that infections associated with abdominal endoscopes were a health risk to patients, despite outbreaks dating back as far as 2012, the Los Angeles Times reports.

An outbreak at a Pennsylvania hospital in late 2012 should have been an early warning that a reusable medical scope was spreading deadly infections and nearly impossible to disinfect, the report concludes.

But FDA staff lost the report, which allowed doctors and hospitals to continue using the scope for three more years even as dozens of patients were sickened.

The findings, based on an analysis of reports from a recent Senate inquiry, underscores the serious shortcomings in the antiquated national database used to monitor the safety of medical devices, the Times concludes.

"We need to build a better system to find these problems more quickly," said Dr. Josh Rising, director of healthcare programs at the Pew Charitable Trusts. Further postponement, he said, "could compromise the safety of millions of Americans."

The device known as a duodenoscope was used in tens of thousands of patients before regulators pinpointed a deadly problem in its design. Regulators did not warn hospitals until after The Times reported an outbreak at UCLA that killed three patients.

After the Senate report’s release on the issue last month, Olympus Corp., the scope's leading maker, said it would recall and redesign the device. Olympus did not respond to a request for comment.

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The FDA took years to decide that infections associated with abdominal endoscopes were a health risk to patients, despite outbreaks dating back as far as 2012, according to a new report.
endoscopes, patient, infections, ucla, fda
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2016-54-11
Thursday, 11 Feb 2016 02:54 PM
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