Pentax gets FDA signoff for updated duodenoscope cleaning instructions

Pentax's ED-3490TK's video duodenoscope--Courtesy of Pentax Medical

The FDA has signed off on updated cleaning and operating instructions for Pentax Medical's video duodenoscope. The move comes as devicemakers face increased scrutiny after superbugs linked to the devices cropped up at U.S. healthcare centers last year.

Pentax's new cleaning instructions replace those in its original device's label and include stricter requirements for pre-cleaning, manual cleaning, high-level disinfection and liquid chemical sterilization procedures. Updated instructions also lay out additional warnings that should clear up questions surrounding how to best clean the devices.

"The agency believes that when followed, these updated, validated reprocessing instructions demonstrate consistent and reliable cleaning, high-level disinfection and sterilization of Pentax's ED-3490TK's video duodenoscope," the FDA said in a safety notice.

Regulators began looking into cleaning for duodenoscopes last year after superbug outbreaks at healthcare centers such as UCLA pointed to problems with the devices. The agency warned that the device's complex design might impede cleaning and cause bacteria to linger, which could in turn infect patients. The FDA also said that it would work with duodenoscope manufacturers to correct the problems.

Pushback over the devices caused many duodenoscope makers, including Pentax, to update their cleaning instructions. Last year, Pentax tested new cleaning procedures for its product and sent reports to the FDA. The FDA called for additional cleaning tests, but Pentax's most recent data were enough to satisfy the agency's requirements.

"We have been working closely with FDA to update these Instructions. Maintaining patient safety and quality is our utmost priority," Frank Canonica, Pentax's chief infection control officer said in a statement. The company recently sent a note to customers about the new cleaning instructions. And Pentax "has a dedicated team of clinical specialists who will be visiting customer facilities to conduct reprocessing in-servicing and training," Canonica said.

Pentax is also discontinuing some older models of its duodenoscope devices in light of the fallout. The company is retiring Pentax Medical 30, 40 and 70 Series duodenoscopes, which hit the market more than 10 years ago. The devices have since been swapped out for Pentax's latest model, the ED-3490TK. Company reps will reach out to customers with the older model to help them make the switch, Pentax said.

Pentax is not the only duodenoscope maker rolling out new cleaning instructions. Last year, Olympus got an FDA signoff for updated cleaning instructions for its device after the company came under fire for its role in the superbug outbreaks. Last month, Fujifilm got an FDA signoff for updated reprocessing instructions for its ED-530XT duodenoscope.

- read the FDA safety notice
- here's Pentax's statement
- get Pentax's letter to customers

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