The agency wants the three makers of duodenoscopes in the U.S.--Olympus, Fujifilm, and Hoya (Pentax)--to conduct postmarket surveillance studies.
FDA has ordered the three companies that sell duodenoscopes in the United States to study how the hard-to-clean devices are reprocessed in actual clinical settings.
Used in about half a million U.S. procedures each year, the scopes have been linked to deadly superbug outbreaks since early this year 2015.
In its latest move to reduce patient risk, FDA has ordered Olympus America Inc., Fujifilm Medical Systems U.S.A. Inc., and Hoya Corp. (Pentax Life Care Division) to submit postmarket surveillance plans to the agency within 30 days.
The companies must detail their plans to conduct studies that will evaluate, among other things, how well healthcare workers follow instructions to clean and disinfect duodenoscopes between patient procedures. The studies may also increase understanding of the scopes' contamination rates.
FDA has ordered the studies based on its understanding of factors that may be contributing to infection outbreaks following endoscopic retrograde cholangiopancreatography procedures (ERCP), as well as the information needed to help fill gaps in knowledge, the agency said in a statement.
Duodenoscopes are flexible, lighted tubes that are threaded down through the digestive tract and into the small intestine to provide the least invasive way of draining fluids from pancreatic and biliary ducts blocked by cancerous tumors, gallstones, or other conditions. The scopes' movable "elevator" mechanism at the tip, while improving efficiency and effectiveness, is challenging to disinfect, according to FDA.
FDA wants the manufacturers' studies to answer three questions:
- Are user materials, such as manuals, brochures, and quick reference guides included in the manufacturers' duodenoscope labeling and instructions for use, sufficient to ensure that users adhere to the manufacturers' reprocessing instructions?
- After reprocessed according to the manufacturer's validated reprocessing instructions, what percentage of clinically used duodenoscopes remains contaminated with viable microorganisms?
- What factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?
Olympus is reviewing the FDA order, according to spokesperson Mark Miller.
"We take this matter extremely seriously, and we intend to comply and provide the requested information," Miller wrote in an email.
A Fujifilm spokesperson, Diane Rainey, also responded: "We are currently reviewing the Postmarket Surveillance Study order issued by the FDA on October 5th. As patient health and safety is the number one priority for Fujifilm, we will continue to work with the agency to ensure the best long-term sustainable practices."
The other manufacturers did not respond to requests for comment.
Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.
Nancy Crotti is a contributor to Qmed and MPMN.
Like what you're reading? Subscribe to our daily e-newsletter.