Manufacturers failed to report infections from duodenoscopes, US investigation findsBMJ 2016; 352 doi: https://doi.org/10.1136/bmj.i240 (Published 14 January 2016) Cite this as: BMJ 2016;352:i240
- Michael McCarthy
Manufacturers of hard to clean duodenoscopes that spread potentially life threatening, antibiotic resistant bacterial infections to hundreds of patients in the United States and Europe failed to meet their legal obligations to report serious infections and deaths to federal regulators, says a US Senate committee report released on 13 January.1
The report, the result of a year long investigation by the Senate Health, Education, Labor, and Pensions Committee, also found that almost all the US hospitals where the infections occurred failed to properly inform health officials of the outbreaks. The investigators estimated that the outbreaks, which occurred in 2013 and 2014, were responsible for at least 250 deaths, considerably more than previous estimates.
“These outbreaks occurred despite the fact that the manufacturer of 85% of the duodenoscopes used in the United States, Olympus, was aware by early 2012 that its …