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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies Database

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The FDA has the authority to require device manufacturers to perform postmarket surveillance under Section 522 of the Food, Drugs and Cosmetics (FD&C) Act, when questions are identified for devices that meet the statutory criteria. This database contains information about 522 Postmarket Surveillance Studies that have been required. This database allows you to search information about the postmarket surveillance requirements by manufacturer or device.

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  To search for Manufacturer beginning with a specific letter, select that letter

Human Factors Study

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Study Status Completed
522 Number / Requirement Number PS150002 / PSS001
Date Original Plan Accepted 08/01/2017
Date Current Plan Accepted 08/01/2017
Study Name Human Factors Study
Device Name Fujifilm duodenoscopes
Root Document Number K944759  K944620  K042076 
General Study Protocol Parameters
Study Design Other Study Design
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population
Detailed Study Protocol Parameters
Study Objectives The objective of this study is to determine if representative reprocessing personnel can understand and follow the recommended reprocessing instructions for ED-530XT duodenoscopes without causing reprocessing errors or failures. Duodenoscopes are flexible side-viewing gastrointestinal endoscopes used in patients undergoing ERCP procedures to address problems with the bile ducts or pancreatic ducts.

In this simulation study, trained healthcare facility staff (including GI nurses and GI techs) will reprocess ED-530XT duodenoscopes in accordance with Fujifilm’s reprocessing manual for this device model.
Study Population The study population consists of Fujifilm model ED-530XT duodenoscopes that will be reprocessed by trained healthcare facility staff in accordance with the duodenoscope reprocessing manual.

The ED-530XT Operation Manual reprocessing instructions serve as the instructions for use (IFU) for the required manual cleaning, disinfection, and sterilization (CDS) processes users must follow prior to using the duodenoscope for the first time and immediately following each use during a surgical procedure. The ED-530XT Quick Reference Guides (QRGs) serve as supplements to the IFU for the required CDS processes.

Test participants will reprocess ED-530XT duodenoscopes in accordance with Fujifilm’s reprocessing manual. Participants in this simulation study will represent the actual population of intended users for the ED-530XT CDS IFU and QRGs. Two user groups of representative users will be included in the human factors testing: (1) nurses who perform duodenoscope/ GI flexible endoscope reprocessing activities, and (2) technicians who perform duodenoscope/ GI flexible endoscope reprocessing activities.
Sample Size A minimum of 30 test participants (including 15 GI nurses and 15 GI techs) will reprocess the ED-530XT duodenoscopes.

Key Study Endpoints During the simulation testing session, trained human factors moderators will record each participant-device interaction. Results of the usability portion of the study will represent the number of successful critical CDS labeling uses as well as the number of occurrences of critical failures, use errors, close calls (near misses), and reprocessing difficulties/hesitations for each scenario. User performance data (i.e., observable data from use scenarios, completion times for higher level tasks, and responses to critical task questions), debriefing interview data (subjective data), and knowledge interview data (knowledge data) will be analyzed to evaluate if users can understand and follow the labeling to safely and effectively reprocess the ED-530XT duodenoscope.
Interim or Final Data Summary
Final Effectiveness Findings The Human Factors study results indicate that the current reprocessing instruction manual for the Fujifilm ED-530XT duodenoscope is not sufficient to consistently ensure user adherence in these core reprocessing areas: precleaning, manual cleaning and manual high-level disinfection. Among the critical precleaning tasks, two of the eight precleaning tasks were not successfully performed by a majority of participants. For example, 41% of participants failed to correctly provide air, then water through the air/water channel, and 67% failed to correctly clean the forceps elevator. Of the 33 critical manual cleaning tasks, only two tasks were successfully performed by all participants, and in one manual cleaning task, 100% of participants failed to correctly flush the surfaces and inspect the movable parts. Among the critical manual high-level disinfection tasks, 13 of 21 high-level disinfection tasks were not successfully performed by all participants. For example, 93% of participants failed to wipe and dry the scope and cleaning kit as instructed in the labeling and 67% of participants failed to purge the channels with compressed air for the required time. In addition, most participants expressed some difficulty adhering to the reprocessing manual, including misunderstanding information and difficulties finding information.

Human Factors Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
2 month report 09/30/2017 09/29/2017 On Time
4 month report 11/29/2017 11/29/2017 On Time
6 month report 01/28/2018 01/26/2018 On Time
50% Data Collection Report 03/19/2018 03/13/2018 On Time
8 month report 03/29/2018 03/29/2018 On Time
10 month report 05/28/2018 05/29/2018 On Time
Final report 07/27/2018 07/27/2018 On Time