The “superbug” infections were a global wave of infections eventually linked to contaminated duodenoscopes. The United States Senate has concluded that the problem could have been partially minimized if communication had been better facilitated.
From 2012 to 2015, there were at least 250 people affected by contaminated endoscopes in 25 separate outbreaks throughout the world, according to a Senate Health, Education, Labor, and Pensions Committee report.
The study, called "Preventable Tragedies: Superbugs and How Ineffective Monitoring of Medical Device Safety Fails Patients,” also notes that Olympus (the manufacturer of more than 85% of the duodenoscopes that are used in this country) was aware of the infection risks. In fact, Olympus knew of the risks as early as 2013. However, they made no move to let the FDA know about the risks until 2015.
The FDA and Olympus
Once Olympus alerted them, the FDA did not tell hospitals, the public or health care workers of this risk for another 17 months. The report notes that during that 17-month period, another 68 people were infected by bacteria-laden duodenoscopes.
All of these outbreaks, and now the report noting Olympus's silence, have set off a wave of lawsuits. These lawsuits allege that Olympus had a hand in wrongful deaths and committed fraud and negligence.
While the Senate report does single out Olympus, it also takes issue with the FDA. The Senate calls the agency's information gathering system outdated, and notes that they need to revamp their current processes.
Others at Fault
While Olympus and the FDA should take their share of the blame when it comes to the superbug infections outbreak, hospitals are not completely blameless. They seemed to fail at noting just how dangerous the situation could be. The Senate report says that "…not a single hospital that experienced infection outbreaks tied to the duodenoscopes sent the required adverse event form to the device manufacturers.”
The report also noted that if the communication had been better, lives could have been saved.
The Senate report concludes "When hospitals did take required action to report adverse events to device manufacturers, it was often late, notification was made informally by phone or email, and reports were not inclusive of all the information necessary for the manufacturers to themselves submit accurate and complete information to the FDA.”
The Senate then called for a number of reforms, including:
• The mandate of unique medical device identifiers to be included in insurance claims. They also want a federally funded National Medical Device Evaluation System that will ensure the agency is able to monitor these medical devices.
• The Senate wants the FDA to reevaluate the design of closed-channel duodenoscopes, noting which need to be repaired.
• Most importantly, the Senate wants the FDA to implement a process to work more quickly to disseminate information to health care providers when the agency becomes aware that patient safety may be at risk.
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