The QMN Weekly Bulletin
Medical Devices / Postmarket Safety

Pentax Updates Reprocessing Guidelines for Duodenoscopes

April 29, 2016

The FDA has signed off on reprocessing instructions for Pentax’s ED-3490TK video duodenoscope that aim to prevent future of infections related to drug-resistant bacteria.

Pentax and two other companies that make duodenoscopes — Olympus and Fujifilm — have faced intense scrutiny after reports of antibiotic-resistant infections in Chicago, Pittsburgh, Seattle and Los Angeles. In early 2015, the FDA revealed that between January 2013 and December 2014, it had received 75 reports involving about 135 patients suffering from carbapenem-resistant Enterobacteriaceae transmissions linked to these devices.

All three companies received warning letters last year for a range of problems related to duodenoscopes, including failure to inform the FDA in a timely manner about patient injuries.

For its part, Pentax has updated its instructions include a more rigorous protocol for precleaning, manual cleaning, manual high-level disinfection and liquid chemical sterilization procedures. In addition, updated instructions include additional text, figures, cautions and warnings intended to clarify the validated reprocessing procedure.

The key changes include additional detail for:

  • Flushing the elevator mechanism with detergent during precleaning;
  • Preparation and use of detergent solution during manual cleaning;
  • Brushing the instrument channel inlet during manual cleaning;
  • High-level disinfectant preparation and use during high-level disinfection; and
  • Flushing the elevator mechanism during high level disinfection.

Other changes involve increased volumes of fluids for internal channels during cleaning and high-level disinfection, an increased number of endoscope rinses after detergent immersion, as well as the removal of ethylene oxide and addition of Steris System 1E as a liquid chemical sterilization method.

Pentax has sent a letter to healthcare facilities and other users of the ED-3490TK video duodenoscope outlining the updated, validated reprocessing instructions.

Pentax began modifying its reprocessing protocol in February 2015 and initiated testing three months later to validate its updated reprocessing instructions. Between July and September 2015, the company conducted additional testing to ensure its high-level disinfection protocols demonstrated an adequate safety margin. In October 2015, Pentax submitted cleaning, high-level disinfection and sterilization reports to the FDA.

The FDA reviewed the data and requested additional cleaning tests, which Pentax conducted. In January of this year, the company submitted additional test data, which the agency reviewed and found to be adequate.

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