The U.S. Food and Drug Administration has ordered three duodenoscope manufacturers — Olympus, Fujifilm and Hoya Corp. (Pentax Life Care Division) — to perform postmarket surveillance studies to increase their understanding of how the devices are reprocessed in real-world settings.
The manufacturers will have 30 days to submit their postmarket surveillance plans to the FDA. The plans are required to include details on the following three concerns.
1. Do the manufacturers' manuals, brochures and reference guides provide adequate reprocessing instructions?
2. After the reprocessing instructions are validated, what percentage of the clinically used duodenoscopes remains contaminated?
3. For devices that remain contaminated after being reprocessed according to the manufacturer's instructions, what do users need to do to adequately decontaminate the device?
According to the FDA, the goal of these studies is to collect data about the effectiveness of current reprocessing instructions, which is necessary to protect the public health and reduce the risk of duodenoscope infections.
"This is a significant step in the effort to combat infections spread through duodenoscopes," said William Maisel, MD, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health.
Earlier this year, infection outbreaks at Ronald Reagan UCLA Medical Center in Los Angeles, Cedars-Sinai Medical Center in Los Angeles and Seattle-based Virginia Mason Medical Center were linked to these types of scopes.
More articles on scope-related infections:
Superbug infections tied to scopes may have affected VA medical centers
FDA releases new guidance for cleaning 'unsafe' scopes
Scope-related infection estimates inaccurate and outdated, researchers say