Reprocessed Urologic Endoscopes Harbor Infection Risk

The warning comes after submission of more than 450 reports by manufacturers relating post-procedure infections and other possible contamination problems associated with the cleaning and sterilization of the devices.

Among these, Olympus (Tokyo, Japan) submitted three reports of deaths attributed to a bacterial infection. In two of these, the infection was linked to a forceps/irrigation plug, an accessory component used to control water flow and enable access to the working channel of the endoscope. The third victim's death involved a cystoscope that did not pass a leak test. According to the FDA, while not officially confirmed, it is possible that the damaged devices were a factor in the patients’ becoming infected.

“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, MD, JD, director of FDA’s Center for Devices and Radiological Health. “While some reports indicate the potential causes could be inadequate reprocessing or device maintenance issues, we’re also evaluating other possibilities, including device design or the reprocessing instructions in the labeling.”

“Although we believe that the risk of infection is low based on available data, we’re reminding health care providers how important it is to follow the labeling and reprocessing instructions to properly clean and reprocess the devices, including accessory components,” concluded Dr. Shuren. “We take all reports of adverse events seriously, and we encourage prompt reporting to the FDA to help us identify and better understand the risks associated with reprocessed medical devices.”

Inadequate reprocessing of endoscopic devices between patients can result in the retention of blood, tissue, and other biological debris, which can allow microbes to survive the disinfection or sterilization process. Inadequate reprocessing can also result in other adverse patient outcomes, such as tissue irritation from residual chemical disinfectants.


Related Links:
US Food and Drug Administration
Olympus