U.S. Senate Report Cites FDA, Hospitals, Manufacturers for Inadequate Safety of Medical Devices Linked to “Superbug” Outbreaks

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After an extensive investigation, the United States Senate’s Health, Education, Labor, and Pensions Committee recently issued a report implicating medical device manufacturers, hospitals, and the U.S. Food and Drug Administration (FDA) in the hundreds of illnesses and deaths involving antibiotic-resistant bacteria linked to endoscope medical devices. Multiple endoscope manufacturers have affirmed their commitment to patient safety, but this issue may provide grounds for significant product liability lawsuits involving medical device failure to warn. Similarly, hospitals that failed to protect or disclose essential information to patients who undergo endoscopy or other medical procedures involving use of endoscopes may be exposed to lawsuits for hospital negligence. The attorneys at Fronzuto Law Group regularly represent clients in cases of hospital negligence, medical malpractice, and medical device failure to warn throughout New Jersey. If you are faced with a similar situation and have questions, simply contact our offices anytime at 973-435-4551 for additional information. We are available anytime to discuss your case and provide a consultation free of charge.

The aforementioned report, entitled Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients, summarizes the results of the investigation, which was initiated because of the at least 250 antibiotic-resistant bacterial infections that have occurred internationally since 2012. In particular, these “superbugs” have been linked to contaminated endoscopes, many of which have caused these illnesses in U.S. hospitals.

Infections Caused by Endoscopes

The first link between antibiotic-resistant infections and endoscopes was made in September of 2013, when multiple patients were infected at Virginia Mason Hospital and Medical Center in Seattle, Washington. After an investigation at the hospital, these illnesses were tied to a medical device called a  closed channel duodenoscope, which is used primarily to identify and treat issues in the pancreas and bile duct. A second similar instance occurred at a hospital near Chicago during the same time period.

According to the Senate report, the phenomenon of antibiotic-resistant infections caused by unsanitary endoscopes continued until media attention brought the issue to the forefront in 2015. Now, investigators say that the FDA has been inadequately ensuring the safety of the America public through its failure to monitor and disseminate information regarding dangerous medical devices.

The Senate cited multiple instances of failure on the part of the FDA, including:

  • Delayed warnings to the American public: the FDA warned hospitals and the public about the risk of the endoscope and antibiotic-resistant bacteria connection 17 months after the link was first detected in U.S. hospitals in Seattle and Illinois
  • Failure to identify a pattern: the FDA utilizes a “passive” monitoring system, accumulating reports from hospitals and companies to assess potential dangers. Although at least 11 hospital outbreaks of superbugs were linked to duodenoscope devices by September 2013, the agency failed to identify a pattern until informed by the United States Centers for Disease Control (CDC).

The investigation also pointed to negligent behavior on the part of device manufacturers and hospitals. As for duodenoscope device manufacturers, particularly the company Olypmus, which produces the majority of duodenoscopes in the U.S., they allegedly failed to inform U.S. hospitals of the potential contamination issues with their products, but did inform European hospitals that they may present problems for effective cleaning.

With regard to hospitals, the Senate investigation revealed lack of reporting protocol in many of the hospitals that saw superbug outbreaks. According to the report, 16 U.S. hospitals that experienced antibiotic-resistant bacterial infections connected with  duodenoscopes failed to expediently and thoroughly disclose the incidents to the product manufacturers or the FDA. Some hospitals didn’t even inform patients whose health was in jeopardy.

So, how far does the problem extend? Duodenoscope devices are employed in 700,000 medical procedures each year in the United States alone. Internationally, these devices have been involved in at least 25 outbreaks of antibiotic-resistant bacteria and have caused 250 documented cases of illness thus far. Although the FDA has indicated that it will attempt to inform the public more quickly of potential dangers to medical devices, the need for direct and immediate action is clear.

Suffered an Infection from Endoscopy Malpractice? Get NJ Lawyer Help Now

If you or a loved one suffered a bacterial infection or another illness due to a contaminated endoscope or unsanitary conditions during an endoscopy, contact Fronzuto Law Group today at 973-435-4551 for a free review of your case. Our lawyers have years of experience handling medical malpractice litigation and we are here to answer your questions, address your concerns, and discuss the options you may have to file suit against those responsible for your injuries. Contact us online or by phone today to learn more.

For additional information pertaining to this issue, access the following article: Senate Report Says FDA Fails to Ensure Medical Devices Are Safe

To read the recent Senate report in its entirety, follow this link: Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients

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