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FDA Wants Postmarket Studies on Scopes
The three manufacturers of duodenoscopes sold in the United States must run postmarket surveillance studies focused on reprocessing practices and results.
Marie Thibault
October 6, 2015
3 Min Read
Marie Thibault
FDA continues its scrutiny of duodenoscopes with a request for postmarket study plans from the three manufacturers of duodenoscopes used in the United States. Olympus America, Inc, Fujifilm Medical Systems, USA, Inc., and the PENTAX Life Care Division of Hoya Corp. must give FDA their postmarket surveillance proposals within 30 days.
Duodenoscopes, a type of endoscope used to diagnose and treat diseases of the liver, bile duct, and pancreas, have been blamed for causing numerous cases of carbapenem-resistant enterobacteriaceae (CRE) infections. FDA previously published recommendations and finalized guidance on cleaning and reprocessing these devices.
The regulator wants to see studies the focus on whether reprocessing and cleaning instructions can be followed effectively, how often reprocessed scopes are still contaminated, and what it takes to ensure these still-contaminated scopes are clean.
"These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA's actions to protect the public health and help reduce the risk of infections," said William Maisel, MD, MPH, deputy director for science and chief scientist at CDRH, in an FDA press release.
In an e-mail, an Olympus spokesperson wrote, "Olympus is reviewing the 'Postmarket Surveillance order for Duodenoscopes' received from the FDA. We take this matter extremely seriously and we intend to comply and provide the requested information."
A spokesperson from Fujifilm Medical Systems USA wrote, "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."
PENTAX Medical said in an e-mailed statement, "PENTAX Medical intends to cooperate fully with FDA to meet this request. The Company is committed to ensuring that our devices meet the highest standards of safety and quality. We have been working closely with FDA, healthcare providers, industry leaders, CDC, and others to address concerns related to duodenoscopes and emphasize patient safety."
FDA want the postmarket studies to examine these three issues:
"Are user materials, such as user manuals, brochures and quick reference guides included in the manufacturers' duodenoscope labeling and instructions for use, sufficient to ensure user adherence to the manufacturers' reprocessing instructions?
"After use of the manufacturer's validated reporcessing instructions, what percentage of clinically used duodnoscopes remain contaminated with viable microorganisms?
"For devices that remain contaminated after use of the manufacturers' labeled reprocessing instructions, what factors contribute to microbial contamination and what steps are necessary to adequately decontaminate the device?"
FDA expects the findings from these studies to lead to improved methods for preventing future infections from duodenoscopes.
Editor's note: This article has been updated to include comment from PENTAX Medical.
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Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.
[Image courtesy of RENJITH KRISHNAN/FREEDIGITALPHOTOS.NET]
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