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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS150003 / PSS001 |
| Date Original Plan Accepted |
09/01/2017
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| Date Current Plan Accepted |
09/01/2017
|
| Study Name |
Human Factors Study
|
| Device Name |
Duodenoscopes
|
| 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
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| Analysis Type |
Descriptive
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| Study Population |
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| Detailed Study Protocol Parameters |
| Study Objectives |
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
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| Study Population |
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.
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| 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
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| Key Study Endpoints |
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.
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| 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.
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