FDA orders duodenoscope makers to conduct studies on devices

duodenoscope 210x210 FDA orders duodenoscope makers to conduct studies on devicesThe Food and Drug Administration (FDA) is ordering three manufacturers of specialized endoscopes called duodenoscopes, blamed for spreading drug resistant superbugs at several hospitals in the United States, to conduct studies to evaluate how the devices work and what can be done to stop the spread of more infections.

Duodenoscopes are flexible tubes that are fed down a patient’s esophagus to treat or diagnose various gastrointestinal conditions. The surgical tools, considered key in illness detection and treatment, are used in about a half million procedures each year.

The devices have small crevasses that researchers say can harbor bacteria. These spaces are difficult to reach during cleaning and disinfecting, thus bacteria can remain and, when the device is reused, can spread the bacteria from patient to patient.

Duodenoscopes are made by three manufacturers – Olympus America, Fujifilm Medical Systems, and Pentax Medical. The FDA ordered all three manufacturers to submit plans for postmarket surveillance to the agency within 30 days. Those plans are required to include details about cleaning and disinfecting of the devices and how health care staff can better understand the rate and threat of contamination with these devices.

Recently, the FDA issued new guidelines for cleaning and disinfecting the devices, however the agency pointed out that some medical facilities may not be equipped to follow the new guidelines. And even if the guidelines are followed, there are no guarantees all the bacteria will be eliminated.

Source: Tech Times