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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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Sampling and Culturing

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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

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.

Sampling and Culturing Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
interim report 02/18/2020 02/18/2020 On Time
3 month report 03/05/2020 03/12/2020 On Time
6 month report 06/05/2020 06/08/2020 On Time
9 month report 09/05/2020 09/08/2020 On Time
1 year report 12/05/2020 12/07/2020 On Time
15 month report 03/05/2021 03/05/2021 On Time
18 month report 06/05/2021 06/07/2021 On Time
interim report 07/28/2021 07/22/2021 On Time
21 month report 09/05/2021 09/07/2021 On Time
24 month report 12/05/2021 12/06/2021 On Time
interim report 03/05/2022 03/07/2022 On Time
final report 03/28/2022 03/29/2022 On Time

Contact Us

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

Additional Resources