Senate Report Says FDA, Scope Makers Failed to Warn about Superbug Risk

A Senate report says that medical device makers, the U.S. Food and Drug Administration (FDA) and hospitals all share blame in the outbreak of several superbug infections linked to contaminated duodenoscopes. The devices, which are used to treat and diagnose disorders in the pancreas and bile duct, have been under scrutiny in light of the outbreaks, which took place over a three year period. The U.S. Food and Drug Administration (FDA) warned last year that the devices could spread antibiotic-resistant bacteria, even when cleaned according to manufacturer’s instructions. The agency said the complex design of the scopes may prevent them from being sterilized effectively.

Device maker Olympus controls most of the market for duodenoscopes in the United States. Duodenoscopes are also manufactured by Pentax and Fujifilm. In January 2015, Sen. Patty Murray’s office launched an investigation into the scopes. The Senate report stemming from that investigation revealed that Olympus knew its scopes could spread bacteria after cleaning as early as 2012. However, the report states, the company did not notify hospitals, patients or the FDA.

The report also criticizes the FDA for its delayed action. The agency learned of the scope-linked infections in 2013, but took an additional 17 months to warn the public. In the time it took the FDA to issue a safety alert, 68 patients in seven hospitals across the US were infected with antibiotic-resistant bacteria following procedures with a duodenoscope. “The failure of FDA’s device surveillance system to rapidly identify and respond to duodenoscope-related superbug and antibiotic-resistant infections serves as just one example of the fallacy of a system that is primarily reliant on hospitals and device manufacturers to self-report information to FDA,” the report states.

According to the report, hospitals also failed to take the necessary steps to prevent further superbug infections. The scopes were linked to infections at 16 different hospitals, but they failed to notify the FDA. The report states that at least 250 people became ill from 25 different superbug infections between 2012 and the spring of 2015.

The report found Olympus did not alert the FDA about the risk of spreading infection. The company learned of two independent lab reports showing bacteria could still be alive after cleaning in early 2013, but did not inform the FDA until February 2015. Additionally, the report says that Olympus, Pentax and Fujifilm all failed many regulatory requirements. “The duodenoscope manufacturers and Custom Ultrasonics failed at every level to meet basic expectations of transparency and openness and to actively engage with FDA to address contamination issues,” Sen. Murray wrote, according to Law360. “This disregard for the spirit, and sometimes the letter, of the law resulted in potentially preventable serious and potentially fatal illnesses in hospitals around the world.”

from Parker Waichman http://www.yourlawyer.com/blog/senate-report-says-fda-scope-makers-failed-to-warn-about-superbug-risk/