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| Chaffin Luhana LLP

About a year ago, the FDA announced that Olympus America was recalling their TJF-Q180V duodenoscope to update it with new design and labeling modifications. This was to help reduce the risk of antibiotic-resistant infections that have been linked to the device and have plagued several hospitals over the past few years. The recall was big news across the country because Olympus hold around 85 percent of the market share for these types of endoscopes..

In January 2017, however, the FDA released another safety communication, warning about the Pentax-brand duodenoscopes. The FDA warns that these devices are also linked to a potential increased risk of infection.

Pentax Updated Their Duodenoscope Cleaning Instructions Last Year

This recent FDA communication is an update to their previous February 19, 2016 safety communication, which informed healthcare providers about potential design issues with the Pentax Ed-3490TK duodenoscope. Pentax also issued updated cleaning instructions for this device at that time, to replace the instructions they delivered with the original device labeling.

The company modified its cleaning instructions because of concerns about antibiotic-resistant infections. Duodenoscopes are small, tube-like tools that doctors use to examine the stomach, gallbladder and pancreatic duct, and to diagnose and treat problems in these areas. They are meant to be cleaned and disinfected after each use, and then to be re-used in patient after patient.

If not properly cleaned, however, residual body fluids and debris can remain in tiny crevices in these devices, potentially exposing other patients to the risk of infection. The FDA stated in early 2016 that they were working with duodenoscope manufacturers to validate their cleaning instructions to “further enhance the safety margin of their devices.”

Pentax’s new cleaning instructions included a more rigorous protocol for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilization procedures. The changes were supposed to help protect patients, but now, just a year later, Pentax has announced another potential safety issue.

Pentax Duodenoscope May Increase Risk of Patient Infection

On January 17, 2017, the FDA announced that the Pentax ED-3490TK has a “design issue” that could increase the risk of patient infections. According to the FDA, “[c]racks and gaps in the adhesive that seals the device’s distal cap to its distal tip may occur, which can lead to microbial and fluid ingress. These areas can be challenging to clean and high-level disinfect and may increase the risk of infection transmission among patients.”

To address these safety issues, the FDA recommends that hospitals, medical centers, and their staff members be sure they’re using Pentax’s updated cleaning instructions for the device. They were also told to repair or replace any duodenoscopes that show visible signs of damage, including kinks or bends in tubing, loose parts, cracks and gaps in the adhesive, or other signs of wear and tear.

So far, however, Pentax has chosen not to issue a recall of these devices. Olympus, which recalled their devices last year to update the design, created a tighter seal to reduce the potential for leakage of patient fluids and tissue. The FDA approved this new design last year. Prior to that, at least 16 hospitals in the U.S. had reported antibiotic-resistant infections related to the Olympus and other brands of duodenoscopes.

Olympus is currently defending several duodenoscope infection lawsuits. Pentax may soon face its own liability issues.

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