Three major suppliers of duodenoscopes have received warning letters from the FDA for failing to conduct postmarket surveillance studies into the effectiveness of reprocessing the devices. Olympus, Fujifilm and Pentax were ordered by the FDA in 2015 to conduct studies to assess whether healthcare facilities were able to properly clean and disinfect the devices. The ...
Duodenoscope makers get FDA warning over disinfection studies
15 Mar 2018