ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - Pentax Validates Reprocessing Instructions

[Posted 02/19/2016]

AUDIENCE: Risk Manager, Gastroenterology, Surgery, Infectious Disease, Nursing

ISSUE: PENTAX has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using PENTAX ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible.

BACKGROUND: As noted in the FDA’s February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. If not properly reprocessed, residual body fluids and organic debris may remain in microscopic crevices of the device following an attempted cleaning and high level disinfection. If these residual fluids contain microbial contamination, subsequent patients may be exposed to serious infections. The FDA has been working with duodenoscope manufacturers as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.

In February 2015, PENTAX began modifying its reprocessing protocol and, in May 2015, initiated testing to validate its updated reprocessing instructions. Between July and September 2015, PENTAX conducted additional testing to ensure its high-level disinfection protocols demonstrated an adequate safety margin. In October 2015, PENTAX submitted their cleaning, high-level disinfection and sterilization reports to the FDA. The Agency reviewed this data and requested additional cleaning tests, which PENTAX conducted. PENTAX submitted additional test data in January 2016, which the Agency reviewed and found to be adequate.

RECOMMENDATION: The updated reprocessing instructions for the ED-3490TK Video Duodenoscope include a more rigorous protocol for pre-cleaning, manual cleaning, 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 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.

PENTAX sent a letter dated February 19, 2016 disclaimer icon to health care facilities and other users of the ED- 3490TK Video Duodenoscope outlining the updated, validated reprocessing instructions. Updated Reprocessing Instructions for Use (IFU) and the Operation IFU accompanied the notification letter that PENTAX sent to its ED-3490TK customers.  Please see the FDA Safety Communication for more details.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[02/19/2016 - FDA Safety Communication - FDA]