The US Food and Drug Administration (FDA) is giving three duodenoscope makers 30 days to submit plans to conduct safety studies to help the agency understand the effectiveness of current cleaning instructions for these products.

Background

In recent years, insufficient cleaning procedures have linked duodenoscopes to several bacterial outbreaks. The most notable was an outbreak of carbapenem-resistant Enterobacteriaceae (CRE) at the Ronald Reagan UCLA Medical Center in late 2014 and early 2015, which left two patients dead.

In February 2015, FDA released a safety communication warning healthcare professionals that design flaws could make these scopes difficult to clean, even if cleaning instructions are closely followed.

In May 2015, the agency's Gastroenterology-Urology Devices Panel met to discuss:

• The effectiveness of cleaning, high level disinfection and sterilization methods;
• The amount and type of premarket validation data and information needed to support labeling claims and technical instructions;
• The appropriate use of other risk mitigations such as surveillance cultures;
• Best practices and guidelines for reprocessing duodenoscopes and endoscopes at user facilities to minimize the transmission of infections;
• Recommended approaches for ensuring patient safety during ERCP procedures, including a discussion of appropriate patient selection.

On 4 August 2015, after hearing the panel's recommendations, FDA released supplemental instructions intended to aid facilities that reprocess duodenoscopes to do so more effectively.

Shortly thereafter, on 12 August, FDA warned the three manufacturers marketing duodenoscopes in the US –Olympus, Fujifilm and Hoya – for failures related to cleaning procedures and reporting known infections.

New Postmarket Surveillance Requirements

Now, FDA is requiring the three aforementioned companies to develop postmarket surveillance studies at healthcare facilities that use their devices to assist the agency in collecting "useful data about the effectiveness of current reprocessing instructions and practices."

FDA says its investigations have shown that "reprocessing instructions are not always being followed correctly, as these instructions are labor intensive and prone to human error.”                  

The agency is asking the three manufacturers to answer the following questions related to their devices:

• 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 reprocessing instructions, what percentage of clinically used duodenoscopes 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 says that the results of these studies should help the agency determine additional measures to reduce the risk of infection with these devices in the future.

FDA