This archive report was first published on 30 August 2019.
On August 29, 2019, the Food and Drug Administration (F.D.A.) urged hospitals to switch to safer duodenoscope models, citing concerns over the risk of infection to patients.
According to the F.D.A., the current models of duodenoscopes, which are used in approximately 500,000 procedures annually in the United States, cannot be properly sterilized and have been implicated in hospital outbreaks that have sickened hundreds of patients.
Tests ordered by the F.D.A. found that one in 20 duodenoscopes harbored disease-causing microbes like E. coli even after being properly cleaned.
Dr. Jeff Shuren, the director of the agency's Center for Devices and Radiological Health, acknowledged that hospitals would face difficulties in switching to different devices, but emphasized that the risk of infection is relatively low.
"Patients should not cancel or delay any planned procedure without first discussing the benefits and risks with a health care professional," Dr. Shuren said.
However, he urged health care facilities to begin developing a transition plan to replace conventional duodenoscopes with newer models that have disposable components.
There are currently two duodenoscopes with disposable parts available on the market, one made by Pentax Medical and one by Fujifilm, but the F.D.A. is only now ordering the manufacturers to conduct studies on the contamination rates of these new models.
Dr. William H. Maisel, director of the Office of Product Evaluation and Quality in the F.D.A.'s Center for Devices and Radiological Health, said that the agency is convinced that duodenoscopes with disposable parts called endcaps will reduce contamination.
