Product News and Recalls

Manufacturers May Have Under-Reported Duodenoscope Infection Rates

duodenoscope infection rates may have been under-reportedThe bacterial infections attributed to non-sterile duodenoscopes that sickened and killed patients in hospitals in California and Washington last year may have represented just a small fraction of the total number of cases.

A report issued by the United States Senate accuses device manufacturers of failing to report infections within the required 30-day guideline. Such a failure would lead to artificially low numbers.

Washington Senator Patty Murray launched her investigation after a spike in cases of antibiotic-resistant hospital-acquired infections in her home state. Analysis of FDA data showed that 75 infections had been reported worldwide in the two years between January 2013 and December 2014. However, searches of non-governmental data and further investigation showed that at least 250 infections had been discovered from 2012 to the first months of 2015.

The history of duodenoscope-related infections in United States hospitals actually starts outside of the United States. Research showed that Olympus, the primary manufacturer of the devices, had been alerted to a possible issue as early as 2013. The company began notifying hospitals throughout Europe of a possible link between duodenoscopes and patient infections but negated to raise the alarm in the U.S. until just last year. Once notified, some hospitals then delayed notifying their patients until even further into the year.

Putting all of this another way, patients in hospitals throughout the United States seemingly died as the result of an infection and the risk of contracting that infection had been known by multiple parties for years prior.

The FDA, at this point all-too-well accustomed to public second-guessing as a result of several missteps and controversies last year, was cordial to the senator. In a statement, the agency said that they “appreciate the report from Senator Murray and will carefully consider its recommendations, many of which FDA is already taking steps to address. We agree with the senator that a broader approach to understanding how well duodenoscope devices work in real-time use is critical to public health.”

Senator Murray’s report makes recommendations such as a re-evaluation of the design of the duodenoscope with an eye toward recall if necessary. It also suggests the use of unique device identifiers in insurance claims to aid tracking of specific devices’ roles in spreading infections.

The report also urges the creation and funding of a “national medical device evaluation system” – an entity that would ‘monitor the safety of medical devices on the market.”

One would think that this job is already occupied by the FDA.