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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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Human Factors Study

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Study Status Completed
522 Number / Requirement Number PS150004 / PSS001
Date Current Plan Accepted 08/10/2017
Study Name Human Factors Study
Root Document Number K961568  K963056  K092710 
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 Design Description Study objectives for the human factors study are as follows:

1. To demonstrate that representative reprocessing personnel can follow the recommended reprocessing instructions in the ED-3490TK labeling and user materials without causing reprocessing errors or failures that could result in harm to patients.

2. To demonstrate that the ED-3490TK Reprocessing Instructions for Use (RIFU), which collectively refers to both the RIFU itself and related educational materials provided by PENTAX Medical (e.g., reprocessing posters, user checklists, etc.), is sufficient to promote user adherence and comprehension.

In addition, the study seeks to identify human factors that may contribute to microbial contamination of duodenoscopes.

Study Population Description The study population consists of PENTAX model ED-3490TK Video Duodenoscopes, which are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Biliary Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: Esophagus, Stomach, Duodenum, Common Bile, Hepatic and Cystic Ducts.

In this simulation study, trained healthcare facility staff (including GI nurses and GI techs) will reprocess the scopes in accordance with the manufacturer’s duodenoscope reprocessing manual.

Sample Size A minimum of 30 test participants (including 15 GI nurses and 15 GI techs) will reprocess the ED-3490TK duodenoscopes.
Data Collection This is a simulation human factors study that does not have the traditional safety assessments. Representative test participants will use the manufacturers’ reprocessing instructions to complete manual cleaning, disinfection, and sterilization activities for ED- 3490TK duodenoscopes. During the testing session, trained human factors moderator(s) will record each participant-device interaction. The overall performance of test participants will be graded based upon three factors: a. Performance data (user adherence) collected during simulated use testing to determine whether the assigned task was performed correctly

b. Subjective data (user comprehension) collected in response to neutral, open-ended questions posed during a post-performance interview at the end of validation testing

c. Knowledge data (user comprehension) collected after the subjective interview and based upon the RIFU

Interim or Final Data Summary
Final Effectiveness Findings Initial Human Factors testing of the current cleared version of the reprocessing user manual for the PENTAX ED-3490TK evaluated users’ performance and knowledge of the 522 individual tasks in the process. Pentax had set the acceptance criterion for the study for users successfully completing the process. This metric was met, but based on the numbers of failures or near-misses in knowledge and performance in pre-cleaning, manual cleaning, and high-level disinfection tasks, Pentax concluded that the instructions required revision to support user comprehension of and adherence to the reprocessing instructions. The company used root cause analysis to guide a revision of the reprocessing manual to improve the clarity of the instructions, especially in those three areas. The reprocessing protocol itself was not deemed at fault and was not revised.

Pentax conducted a second Human Factors study of the revised Reprocessing Instructions for Use (RIFU). Test participants were able to perform 95% of the reprocessing tasks appropriately. Test participants were able to provide appropriate responses demonstrating understanding of 99% of the tested reprocessing information from the user manual. Based on this, Pentax concluded that the revised RIFU adequately supported user comprehension of and adherence to the reprocessing instructions.

Human Factors Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
2 month report 10/09/2017 10/11/2017 Overdue/Received
4 month report 12/08/2017 12/07/2017 On Time
6 month report 02/06/2018 02/06/2018 On Time
8 month report 04/07/2018 04/06/2018 On Time
10 month report 06/06/2018 06/13/2018 Overdue/Received
12 month report 08/10/2018 08/22/2018 Overdue/Received
14 month report 10/09/2018 10/09/2018 On Time
16 month report 12/03/2018 12/06/2018 Overdue/Received
Final report 02/01/2019 01/23/2019 On Time