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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 Study


 
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General
Study Status Terminated
522 Number / Requirement Number PS150002 / PSS002
Date Original Plan Accepted 12/21/2016
Date Current Plan Accepted 12/21/2016
Study Name Sampling and Culturing Study
Device Name Fujifilm duodenoscopes
Root Document Number K944759  K944620  K042076 
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 the pilot phase (phase 1) of the Sampling and Culturing Study for Fujifilm. This is a laboratory study in which clinically used duodenoscopes will be reprocessed, sampled, and cultured for microbial growth. Duodenoscopes are flexible side-viewing gastrointestinal endoscopes used in patients undergoing ERCP procedures to address problems with the bile ducts or pancreatic ducts.

The objectives of this pilot phase are as follows:
1. Identify clinical sites to collect duodenoscope samples and identify laboratories for culturing those samples.
2. Train staff on sampling and culturing protocols.
3. Pilot the sampling and culturing protocols to identify errors and inefficiencies in the pilot protocols which will allow for streamlining of the sampling and culturing protocols during the pivotal phase (phase 2) of the study.
Study Population The study population consists of Fujifilm model ED-530XT duodenoscopes that have been used in ERCP procedures and reprocessed by trained healthcare facility staff in accordance with the duodenoscope reprocessing manual. Duodenoscopes will be subjected to sampling following completion of the cleaning and manual disinfection or disinfection using any of the following automated endoscope reprocessors (AERs):
• ASP EvoTech ECR
• Medivators Advantage Plus
• Medivators DSD Edge
• Steris Corporation System 1E Liquid Chemical Sterilant Processing System
Sample Size Max # of Pilot
Install Samples Min # of Sample
Base per Scope Scopes Size .
214 30 3 85
Key Study Endpoints The primary endpoint of the pilot phase is successful completion of duodenoscope sampling and culturing, where the duodenoscope samples were collected from clinically used duodenoscopes from the identified 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 to identify the root causes of positive samples will be conducted for any positive sample.
Interim or Final Data Summary
Final Safety Findings To complete the 522 Sampling and Culturing Study, Fujifilm is required to enroll 10 sites and to collect 727 samples. Fujifilm did not enroll a sufficient number of sites or collect a sufficient number of samples to establish a real-world contamination rate.

In their limited data set, Fujifilm was not able to identify the root causes for microbial contamination. They noted that environmental contamination during handling, storage, and sampling could have contributed to microbial contamination of the duodenoscope. Given that the root cause analysis for contaminated duodenoscopes was unable to definitively identify all root causes and in light of the limited data set, their findings may not be representative of all Fujifilm ED-530XT duodenoscopes.

Although Fujifilm was unable to identify all root causes, Fujifilm identified several general mitigations to potentially improve the safe use of duodenoscopes. In addition to those general mitigations, Fujifilm has conducted a market withdrawal of all ED-530XT with fixed distal end caps. FDA has ordered Fujifilm to conduct a sampling/culturing study on their new duodenoscope model with a disposable endcap.

Mitigations
• Market withdrawal of older scope models with fixed components and introduction of newer scope models with disposable end caps
• Conduct 522 sampling/culturing study on new scope model
• Improve the Reprocessing Instructions for Use
• Develop a reprocessing video which will graphically, and with audible text, describe the proper reprocessing process
• Improve training for company personnel and end users


Sampling and Culturing Study Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 month report 01/20/2017 01/19/2017 On Time
2 month report 02/19/2017 02/17/2017 On Time
3 month report 03/21/2017 03/21/2017 On Time
4 month report 04/20/2017 04/20/2017 On Time
5 month report 05/20/2017 05/19/2017 On Time
6 month report 06/19/2017 06/19/2017 On Time
7 month report 07/19/2017 07/19/2017 On Time
8 month report 08/18/2017 08/18/2017 On Time
9 month report 09/17/2017 09/15/2017 On Time
10 month report 10/17/2017 10/17/2017 On Time
11 month report 11/16/2017 11/16/2017 On Time
1 year report 12/21/2017 12/21/2017 On Time
13 month report 01/20/2018 01/19/2018 On Time
14 month report 02/19/2018 02/20/2018 On Time
15 month report 03/21/2018 03/22/2018 On Time
16 month report 04/20/2018 04/20/2018 On Time
17 month report 05/18/2018 05/21/2018 On Time
18 month report 06/19/2018 06/19/2018 On Time
19 month report 07/19/2018 07/19/2018 On Time
20 month report 08/18/2018 08/17/2018 On Time
21 month report 09/17/2018 09/17/2018 On Time
22 month report 10/17/2018 10/17/2018 On Time
23 month report 11/17/2018 11/16/2018 On Time
24 month report 12/17/2018 12/17/2018 On Time
25 month report 01/17/2019 01/17/2019 On Time
26 month report 02/16/2019 02/15/2019 On Time
interim report 03/11/2019 03/11/2019 On Time
27 month report 03/18/2019 03/18/2019 On Time
28 month report 04/17/2019 04/17/2019 On Time
29 month report 05/17/2019 05/17/2019 On Time
30 month report 06/16/2019 06/14/2019 On Time
31 month report 07/16/2019 07/16/2019 On Time
32 month report 08/15/2019 08/15/2019 On Time
33 month report 09/14/2019 09/13/2019 On Time
34 month report 10/14/2019 10/11/2019 On Time
final report 12/30/2019 12/30/2019 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
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