The three manufacturers that market duodenoscopes in the U.S.--Olympus America, Fujifilm Medical Systems and Hoya through its Pentax division--have all been required by the FDA to submit postmarket surveillance plans to the agency within 30 days. This comes after all three received warning letters from the agency in August and an FDA committee panel took up the same issue in May.
It's just the next step in a years-long saga as the FDA works to prevent the spread of infections, sometimes of antibiotic-resistant bacteria, between patients because reusable duodenoscopes have been ineffectively cleaned. Other types of reusable endoscopes have also been called into question as potential sources of infection, since these devices uniformly have difficult-to-clean joints. Meanwhile, industry and hospitals are turning to a variety of solutions including novel cleaning and sterilization approaches and disposable device covers.
The postmarketing data is intended to offer a means for the FDA to better understand precisely how the infections are still occurring, despite cleaning methodologies that have been scrutinized by the FDA and the companies as well as hospitals and healthcare providers themselves.
The proposals must include detailed plans on how the manufacturer will evaluate how well healthcare providers are following instructions on the cleaning and disinfection of duodenoscopes between patients. They are also intended to offer a better tool for assessing the rate of contamination by duodenoscopes in clinical use.
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| CDRH's William Maisel |
"This is a significant step in the effort to combat infections spread through duodenoscopes," said Dr. William Maisel, deputy director for science and chief scientist at the FDA's Center for Devices and Radiological Health, in a statement. "The FDA has undertaken an in-depth investigation into the factors that may play a role in infection transmission associated with duodenoscopes, and is now requiring manufacturers to study the devices in the clinical setting where they are being used."
The postmarket study plans must address the following three questions, the agency said:
- "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?"
Concluded Maisel, "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."
- here is the FDA statement