Washington, DCA damning report issued at the beginning of the year by Senate Health, Education, Labor, and Pensions (HELP) Committee Ranking Member Patty Murray (D-Washington) paints a troubling picture reflective of the risks and realities inherent with endoscope infection, and specifically the increasing difficulties in keeping such complex medical devices clean and germ-free.
Many an Endoscope lawsuit has alleged that duodenoscopes - carrying bacteria from previous patients - were not cleaned properly, or were not capable of thorough cleaning due to a design flaw, thereby passing infections on to other patients. Various design changes, together with the ever-increasing complexity of the devices, make cleaning a chore that health care workers are allegedly not performing properly due to lack of time, or training.
The report is dubbed “Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients.” Murray pulls no punches.
“Following the tragic impacts outbreaks have had on patients and families in my home state and across the nation, I made it my priority to ensure we fully understood how this could have happened in the first place, and what could be done to protect patients going forward,” Senator Murray said. “Patients should be able to trust that the devices they need for treatment are safe and effective. Unfortunately this investigation makes clear that current policies for monitoring medical device safety put patients at risk, and in this case, allowed tragedies to occur that could have, and should have, been prevented. This report lays out steps to address these failures and ensure FDA can appropriately respond to device safety issues, and I am going to continue fighting to protect patients.”
The report was a year in the making, and was initiated following the outbreak of antibiotic-resistant infections (superbugs) at Virginia Mason Hospital and Medical Center in Seattle and Advocate Lutheran General Hospital near Chicago, amongst similar infections at other facilities.
It has been reported that the infections were traced to so-called closed-channel duodenoscopes that remained contaminated even after proper cleaning protocols had been followed.
One of the manufacturers named in the report is Olympus Corp., which makes the vast majority - 85 percent - of duodenoscopes in the United States. According to Murray’s investigative report, Olympus knew as early as 2013 that closed-channel duodenoscopes could harbor trapped bacteria. The revelations were contained in two independent lab reports.
The report found that Olympus never brought this information to the US Food and Drug Administration (FDA), and did not alert hospitals, physicians or patients in the United States to the risk of infection until February of last year.
Meanwhile, the The Philadelphia Inquirer (03/02/16) reports that a whistleblower lawsuit brought against Olympus Corp. by one of its former employees has resulted in a $646 million settlement to resolve various criminal and civil complaints.
It is alleged that between 2006 and 2011, Olympus made various kickbacks and other improper payments to various parties with regard to promotion of its products. The whistleblower, John Slowik, was fired in 2010. His share of the settlement is $51.1 million.
Plaintiffs filing an endoscopic lawsuit have alleged manufacturers including Olympus have known about the potential for dangerous infections spreading between medical devices and unsuspecting patients but did little to notify regulators or the health care community, and could have taken steps to mitigate infections, but failed to do so.
Many an endoscope negligence lawsuit has followed.
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