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January 13, 2016: FDA, Hospitals, Manufacturers at Fault According to Duodenoscope Superbug Outbreak Report

Duodenoscope Superbug Outbreak Report News

After several nationwide duodenoscope superbug outbreaks, Senator Patty Murray (D-WA) initiated an investigation and subsequently released a report analyzing the U.S. Food and Drug Administration’s (FDA), hospitals’, and medical device manufacturers’ role in causing and response to the epidemics.

Senator Patty Murray (D-WA)

Senator Patty Murray (D-WA)

Sen. Murray was motivated to generate this duodenoscope superbug outbreak report, which was released January 13, 2016 and titled “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” by a duodenoscope superbug outbreak in Murray’s home state of Washington.

Duodenoscope Superbug Outbreaks

Duodenoscopes may be used in procedures to drain fluids from blocked pancreatic and biliary ducts, inject contrast dyes, obtain tissue samples for biopsy, or to treat certain medical conditions. The design of certain duodenoscopes may interfere with the ability to sterilize these reusable medical devices, putting patients at risk for infection with potentially deadly multidrug-resistant bacteria called a “superbug”.

Between 2012 and spring 2015, duodenoscopes were linked to at least 25 different instances of superbug infections that sickened at least 250 patients worldwide.

OBTAIN A FREE DUODENOSCOPE LAWSUIT EVALUATION

The Weinberg Law Firm is currently accepting Duodenoscope-linked infection personal injury cases nationwide. If you or someone you know has suffered a CRE infection (also called a “Superbug Infection”) after undergoing ERCP with a reprocessed duodenoscope, please contact our firm toll free at 1-877-934-6274 for a free legal case evaluation. You can also submit our online “Free Legal Case Evaluation Form” to contact one of our lawyers.

• “Device Manufacturers Failed to Meet Regulatory Requirements and Endangered Patients”

Sen. Murray’s investigation revealed that Olympus Corp., the manufacturer of most of the duodenoscopes used in the United States, knew that their duodenoscope could cause infections despite “sterilizing” the device according to the manufacturer’s own instructions. Olympus allegedly knew of this information by early 2013, yet did not share these crucial findings with the FDA, hospitals, or patients in the U.S. until February 2015.

To learn more about duodenoscope manufacturers’ alleged role in perpetuating superbug infection outbreaks visit Olympus Corp. May Have Known Of Duodenoscope Superbug Outbreak Risk.

• “Hospitals Were Slow to Report Infections”

The report also revealed that although at least 16 separate U.S. hospitals traced superbug infections directly to duodenoscope contamination, almost every hospital neglected to timely and urgently alert the manufacturer, the FDA, or the Centers for Disease Control and Prevention (CDC) of the outbreaks.

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If you or a family member has been injured as a result of medical malpractice, and you have a question regarding your legal rights, you can request a free medical malpractice lawsuit case evaluation from our firm by submitting our easy-to-use Lawsuit Case Evaluation Form. You can also call us toll free at 1-877-934-6274. Our phones are answered 24/7.

• “FDA Failed to Recognize the Prevalence of Duodenoscope-Linked Infections and Respond Quickly”

Due to Murray’s investigation, the duodenoscope superbug outbreak report also determined that the FDA was negligent in their handing of duodenoscope superbug outbreaks. The report alleges that the FDA was slow to accept that hospital cleaning errors were not the source of duodenoscope superbug outbreaks.

The FDA began looking into the efficiency of the manufacturer-provided cleaning procedure in preventing infection in late 2013; however, the agency responsible for protecting public health took 17 months to alert hospitals and patients of their suspicions. In those intervening 17 months, at least 68 patients in seven U.S. hospitals caught a duodenoscope superbug infection.

“Preventable Tragedies” Conclusion

The “Preventable Tragedies” report summarizes the organizational and policy flaws that allowed these duodenoscope superbug outbreaks to remain uninvestigated and unimpeded for years:

“Without improved communication for each stakeholder from hospitals to manufacturers to state and local health departments, to FDA and CDC, and without a comprehensive postmarket device surveillance system that supplements self-reporting from hospitals and manufacturers, future device-related safety issues are likely to go undetected for far too long and with life-threatening consequences.”

To see the Senate Press Release and entire Duodenoscope Superbug Outbreak Report visit Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.

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