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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 PS150004 / PSS002
Date Original Plan Accepted 12/08/2016
Date Current Plan Accepted 12/08/2016
Study Name Sampling and Culturing Study
Device Name Duodenoscopes
Root Document Number K961568  K963056  K902710 
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 Pentax. 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 Pentax duodenoscope model ED-3490TK. After clinical use, each duodenoscope under study will be cleaned and reprocessed according to approved instructions before being sampled. Duodenoscopes can either be reprocessed manually or with the aid of an automated endoscope reprocessor (AER). If an AER is used, specific details regarding the AER use will be documented in the study records (e.g., germicide used, concentration, expiration date, cycle setting, number of cycles etc.)
Sample Size Max # of Pilot
Install Samples Min # of Sample
Base per Scope Scopes Size .
=225 17 5 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 # of Sites Enrolled: 8
Total # of Samples Required: 850
# of Properly Collected Samples: 794 *

Results for ED-3490TK Scopes
# of Samples Positive for Low/Moderate Concern Organisms >100 CFU: 65/794 (8.2%) †
# of Samples Positive for High Concern Organisms: 48/794 (6.0%) †

* An additional 98 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, which may include variability in AER usage, maintenance, and calibration, reprocessing personnel staffing resources and turn-over, use of improper reprocessing equipment
o Insufficient reprocessing due to the duodenoscope design including problems with duodenoscope damage that may be related to handling, transport, and storage
o Environmental contamination during reprocessing, handling, sampling, storage

o Improve device design: Remove fixed endcap scope models from market and introduce new scope models, including ED34-i10T2 with a disposable end cap/elevator mechanism
o Conduct 522 sampling/culturing study on new scope model
o Decrease use error: Improve the human factors of the RIFU, simplify instructions, improve training
o Improve reprocessing methods: Improve storage and transport and collaborate with AER manufacturers
o Raise awareness of reprocessing, reprocessing deficiencies, and device damage: Partner with key stakeholders, promote cleaning verification assays and sampling/culturing, conduct more scope inspections

Sampling and Culturing Study Reporting Schedule

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

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