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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Human Factors Study


 
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General
Study Status Completed
522 Number / Requirement Number PS150003 / PSS001
Date Current Plan Accepted 09/01/2017
Study Name Human Factors Study
Root Document Number K853585  K954451  K024033  K080403 
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 To demonstrate that representative reprocessing personnel can follow the recommended reprocessing instructions in the Duodenoscope labeling and user materials without causing reprocessing errors or failures that could result in harm to patients.



The study design consists of the human factors protocol (simulation HF study) which is located on the following pages of the study plan:

TJF-Q180V: pp. 22-35

TJF-160VF and TJF-160F: pp. 732-746 PJF-160: pp. 1516-1530

JF-140F: pp. 1776-1790

Study Population Description The study population consists of Olympus duodenoscope models PJF-160, JF-140F, TJF-160F, TJF-160VF, and TJF- Q180V.



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 Per FDA’s human factors guidance, this study will include a minimum of 15 participants from each user group (i.e., minimum of 15 GI nurses and a minimum of 15 GI technicians), for a total sample size of 30 test participants (at minimum) for each of the 4 Human Factors Study protocols
Data Collection This is a human factors study in which 30 test participants (including 15 GI nurses and 15 GI techs) will reprocess Olympus duodenoscopes in accordance with the manufacturer’s reprocessing manual for the specific device model. The model-specific HF protocols are included on the following pages of the study plan:

TJF-Q180V: pp. 22-35

TJF-160VF and TJF-160F: pp. 732-746 PJF-160: pp. 1516-1530

JF-140F: pp. 1776-1790

Descriptive analyses of the simulation testing results and root cause analyses will be reported.

Interim or Final Data Summary
Final Effectiveness Findings The Human Factors study results indicate that the current user materials for Olympus duodenoscopes are not sufficient to consistently ensure user adherence in these core reprocessing areas: precleaning, manual cleaning, manual high-level disinfection, rinsing, and storage and disposal. The results included the following:



TJF-Q180V: Among the precleaning tasks, 9 out of 12 precleaning tasks were not successfully performed. For example, 40% of participants failed to raise and lower the forceps elevator 3 times by turning the elevator control lever (while continuing the immersion and the aspiration), and 27% of participants failed to release the air/water channel cleaning adapter button to flush air for 10 seconds. Of the 73 critical manual cleaning tasks, 45 were not successfully performed by 27% or more of participants.



TJF-160VF model: Among the precleaning tasks, 17 of the 21 precleaning tasks were not successfully performed. For example, 60% of participants failed to lower the forceps elevator by turning the elevator control lever and immerse the distal end of the insertion section in the water and depress the suction valve (MH-443) on the endoscope and aspirate the water through the endoscope for 30 seconds. Similar examples were observed among the manual cleaning tasks, for example, 87% of participants failed to complete the elevator brushing task described in the user materials.



PJF-160 and JF-140F models: Among the critical manual cleaning tasks, 75 of 111 manual cleaning tasks were not successfully performed. For example, 53% of participants failed to brush the corner of the instrument channel outlet 3 times with the single use soft brush (MAJ-1888) while the bending section is kept straight. Among manual high-level disinfection tasks, 33% of participants failed to confirm that there are no air bubbles on the surfaces of the endoscope and accessories and if air bubbles adhered to the surfaces, wipe them away using a gloved finger or clean, lint-free cloth.



Human Factors Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
2 month report 10/31/2017 10/31/2017 On Time
4 month report 12/30/2017 12/29/2017 On Time
6 month report 02/28/2018 02/28/2018 On Time
8 month report 04/29/2018 04/26/2018 On Time
10 month report 06/28/2018 06/28/2018 On Time
12 month report 08/27/2018 08/27/2018 On Time
Final report 10/04/2018 10/04/2018 On Time


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • CDRH efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov
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