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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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  To search for Manufacturer beginning with a specific letter, select that letter

Sampling and Culturing Study

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Study Status Completed
522 Number / Requirement Number PS150003 / PSS002
Date Original Plan Accepted 11/22/2016
Date Current Plan Accepted 11/22/2016
Study Name Sampling and Culturing Study
Device Name Duodenoscopes
Root Document Number K853585  K954451  K024033  K080403 
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 The objectives of the 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 of the study.
The study design consists of the sampling and culturing protocol (microbiological study) which is located on pages 5-27 of the study plan.
Study Population The study population consists of Olympus duodenoscope models PJF-160, JF-140F, TJF-160F, TJF-160VF, and TJF- Q180V. After clinical use, each duodenoscope under study will be cleaned and reprocessed according to approved Olympus instructions before being sampled. Duodenoscopes can either be reprocessed manually or with the aid of the Olympus OER-Pro AER. If the OER-Pro is used to reprocess the duodenoscopes, detailed
information will be collected to document the specifics of the procedure (e.g. germicide used, concentration, expiration date, cycle setting, number of cycles, etc.).
Sample Size

The pilot study will be conducted in approximately four sites which have access to all five duodenoscope models listed.
Key Study Endpoints This is a microbiological study in which reprocessed duodenoscopes will be sampled and cultured. The laboratory protocol is included on pages 5-27 of the study plan. In brief, clinically used duodenoscopes will be cleaned and reprocessed using Olympus’s approved instructions. The duodenoscopes may be reprocessed manually or with the aid of an automated endoscope reprocessor (the Olympus OER-Pro AER). Samples will be collected from the reprocessed scopes and cultured for microbial growth. This study will report on the number of samples that are positive for any microbial growth, low concern organisms and high concern organisms. 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 # of Sites Enrolled: 18
Total # of Samples Required: 1736
# of Properly Collected Samples: 1718 *

Results for TJF-Q180V Duodenoscopes
# of Samples Positive for Low/Moderate Concern Organisms >100 CFU: 3/859 (0.3%) †
# of Samples Positive for High Concern Organisms: 35/859 (4.1%) †

Results for TJF-160F/VF Duodenoscopes
# of Samples Positive for Low/Moderate Concern Organisms >100 CFU: 10/850 (1.2%) †
# of Samples Positive for High Concern Organisms: 56/850 (6.6%) †

Results for JF-140F and PJF-160 Duodenoscopes
To complete the 522 Sampling and Culturing Study, Olympus is required to collect 18 samples from each of the JF-140F and PJF-160 duodenoscope models (total of 36 samples). Olympus has not collected all of the required samples from these models, and there is an insufficient number of samples to establish a real-world contamination rate.

* An additional 286 samples were collected using unsterile sampling equipment.
† Culturing results for subset of samples collected using sterile equipment (“properly collected”).

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 improper reprocessing procedure
o Insufficient reprocessing due to the duodenoscope design including damage such as problems with glue/adhesives
o Environmental contamination during handling, storage or sampling


Short-Term Action Plan
o Market withdrawal of older duodenoscope models with fixed components and introduction of newer duodenoscope models with disposable end caps
o Conduct additional sampling/culturing studies
o Improve the Reprocessing Instructions for Use
o Improve training
o Partner with professional societies to raise awareness of the importance of reprocessing
o More frequent duodenoscope inspections
o Improve sampling procedure
o Improve endoscope storage and transport
o Monitor and maintain AER condition

Mid/Long-Term Action Plan
o Simplify reprocessing
o Improve the glue
o Develop additional reprocessing technologies
o Collaborate with 3rd parties to improve reprocessing outcomes

Sampling and Culturing Study Reporting Schedule

Reporting Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
1 month report 12/22/2016 12/27/2016 On Time
2 month report 01/21/2017 01/19/2017 On Time
3 month report 02/17/2017 02/17/2017 On Time
4 month report 03/22/2017 03/22/2017 On Time
5 month report 04/24/2017 04/24/2017 On Time
6 month report 05/23/2017 05/24/2017 On Time
7 month report 06/22/2017 06/22/2017 On Time
8 month report 07/22/2017 07/21/2017 On Time
9 month report 08/21/2017 08/18/2017 On Time
10 month report 09/20/2017 09/18/2017 On Time
11 month report 10/21/2017 10/20/2017 On Time
12 month report 11/22/2017 11/20/2017 On Time
13 month report 12/22/2017 12/22/2017 On Time
14 month report 01/21/2018 01/19/2018 On Time
15 month report 02/20/2018 02/20/2018 On Time
16 month report 03/22/2018 03/23/2018 On Time
17 month report 04/21/2018 04/20/2018 On Time
18 month report 05/21/2018 05/21/2018 On Time
19 month report 06/20/2018 06/21/2018 On Time
20 month report 07/20/2018 07/20/2018 On Time
21 month report 08/19/2018 08/17/2018 On Time
22 month report 09/18/2018 09/18/2018 On Time
23 month report 10/18/2018 10/18/2018 On Time
25 month report 12/17/2018 12/17/2018 On Time
26 month report 01/16/2019 01/16/2019 On Time
27 month report 02/15/2019 02/15/2019 On Time
28 month report 03/17/2019 03/18/2019 On Time
29 month report 04/16/2019 04/16/2019 On Time
30 month report 05/16/2019 05/16/2019 On Time
31 month report 06/15/2019 06/13/2019 On Time
32 month report 07/15/2019 07/15/2019 On Time
33 month report 08/14/2019 08/12/2019 On Time
34 month report 09/13/2019 09/13/2019 On Time
35 month report 10/13/2019 10/11/2019 On Time
final report part one 11/04/2019 11/07/2019 On Time
final report part two 12/31/2019 12/31/2019 On Time
final report part three 02/28/2020 02/27/2020 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