|
|
| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS190002 / PSS001 |
| Date Original Plan Accepted |
01/24/2020
|
| Date Current Plan Accepted |
05/19/2021
|
| Study Name |
Sampling and Culturing
|
| Device Name |
Duodenoscope
|
| Root Document Number |
K181745
|
| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
|
| Data Source |
New Data Collection
|
| Comparison Group |
No Control
|
| Analysis Type |
Descriptive
|
| Study Population |
|
| Detailed Study Protocol Parameters |
| Study Objectives |
This is a bench study in which clinically-used model ED-580XT duodenoscopes will be sampled and cultured after reprocessing by trained healthcare facility staff using Fujifilm’s reprocessing instructions.
The study objectives are as follows:
1. Determine the percentage of clinically used duodenoscopes that remain contaminated with viable microorganisms after being reprocessed according to the Fujifilm’s reprocessing instructions.
2. Identify the factors contributing to microbial contamination and the steps necessary to adequately decontaminate the device that remain contaminated after being reprocessed according to the Fujifilm’s reprocessing instructions.
|
| Study Population |
The study population consists of Fujifilm model ED-580XT duodenoscopes that have been used in ERCP procedures and reprocessed by trained healthcare facility staff in accordance with the duodenoscope reprocessing manual.
All duodenoscopes will be subjected to sampling following completion of the cleaning and manual disinfection, or disinfection using AERs listed on the FDA webpage (https://www.fda.gov/medical-devices/reprocessing-reusable-medical-devices/information-about-automated-endoscope-reprocessors-aers-and-fdas-evaluation).
|
| Sample Size |
The study will include a minimum of 36 ED-580XT duodenoscopes at a minimum of 10 sites. The study will continue until 727 properly collected samples are obtained. A maximum of 30 samples will be collected from each scope. No more than 10% of total samples (72 of 727 samples) will come from brand new duodenoscopes. In addition, at least 29 of the 36 scopes used in the study cannot be brand new duodenoscopes.
Study Milestones:
- First sample collected by November 2020
- 20% of samples collected by February 2021
- 50% of samples collected by July 2021
- 100% of samples collected by December 2021
- Final Report submission by March 2022
|
| Key Study Endpoints |
The primary endpoint is successful completion of duodenoscope sampling and culturing to determine real-world contamination rates, where samples are collected from clinically used duodenoscopes from healthcare facilities. Although the expectation is that none of the duodenoscope samples should be positive for high concern organisms or have >100 CFU of low/moderate concern organisms, a thorough investigation will be conducted to identify the root causes of such test results for the identification of the steps necessary to adequately decontaminate the device.
|
| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
Total samples required: 727
Number of properly collected samples: 729
|
| Actual Number of Sites Enrolled |
10 sites
|
| Final Safety Findings |
Results for ED-580XT Duodenoscopes:
# of Samples Positive for Low/Moderate Concern Organisms >=100 CFU: 0/729 (0%)
# of Samples Positive for High Concern Organisms: 8/729 (1.1%)
High concern organisms are defined as organisms that are more often associated with disease. Examples of high concern organisms include Gram-negative rods (e.g., Escherichia coli, Klebsiella pneumoniae or other Enterobacteriaceae as well as Pseudomonas aeruginosa), Staphylococcus aureus, Beta-hemolytic Streptococcus, Enterococcus species, and yeasts.
Factors that May Contribute to Microbial Contamination
o Insufficient reprocessing due to failure to adhere to manufacturer’s recommended reprocessing instructions
o Environmental contamination during reprocessing, handling, sampling, storage
Mitigations
o Strict adherence to manufacturers’ validated instructions including, not only from Fujifilm but also those for third party (non-Fujifilm) products associated with duodenoscope reprocessing including (but not limited to) AERs, channel flushing aids, leak testers, detergents, and channel drying devices.
|
