The U.S. Food and Drug Administration (FDA) announced it is investigating possible infections caused by reprocessing urinary tract observation devices such as urological endoscopes, including cystoscopes, ureteroscopes, and cystourethroscopes.
According to the FDA, there are 450 medical device reports (MDRs) om Jan. 1, 2017, through Feb. 20, 2021, stating post-procedure patient infections or other possible contamination issues associated with reprocessing.
“We are very concerned about the three reported deaths—outside of the United States—associated with these infections, and we’re acting fast to communicate with health care providers and the public about what we know and what is still an emerging issue,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health.
According to Shuren, the infections might be caused by improper reprocessing procedures or device maintenance issues.
Shuren said that they are already looking for possible solutions despite the low risk of infection based on available data.
Shuren said that they are reminding healthcare providers to follow the labeling and reprocessing instructions.