FDA Investigates Possible Infections

A recipient of an MS in pharmacy from Uppsala University, Robert Gadimian draws on 20 years of experience working in large pharmaceutical and small biotechnology companies. The president of Perceptive Regulatory Consulting firm in California, Robert Gadimian engages with several drug industry clients, including the European Medicines Agency (EMA) of the European Union and the U.S. Food and Drug Administration (FDA).

On April 01, 2021, the U.S. Food and Drug Administration announced an active investigation based on numerous medical device reports that describe possible contamination issues linked with reprocessed urological endoscopes, including ureteroscopes, cystoscopes, and cystourethroscopy. The aforementioned devices are utilized by healthcare professionals in the assessment of patients' urinary tracts. Three recent reports have announced mortality associated with these infections outside of the United States, which necessitates action to help communicate educated information to health care providers and the general public.

The current reprocessing method for medical devices, like urological endoscopes, employs high-level disinfection or sterilization, in addition to cleaning, which had made these reprocessed devices considered safe by experts until the recent issue. However, some reports suggest that these infections' potential causes could be poor device maintenance or inadequate reprocessing. FDA is currently evaluating every known possibility, such as device design and reprocessing instruction in labels. Although the risk of infection has been low based on data so far, the FDA aims to pay serious attention to all reports of such adverse events and encourages prompt reporting of such cases to the administration to identify and understand possible risks more effectively.