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U.S. Department of Health and Human Services

522 Postmarket Surveillance Studies

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CENTER FOR DEVICES AND RADIOLOGICAL HEALTH

DIVISION OF EPIDEMIOLOGY

"PROTECTING & PROMOTING PUBLIC HEALTH THROUGH DEVICE SURVEILLANCE AND RESEARCH"



WELCOME TO THE 522 POSTMARKET SURVEILLANCE STUDIES WEBPAGE

 

 

 

 

            

Sampling and Culturing Study


 
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General
Study Status Noncompliant
522 Number / Requirement Number PS150004 / PSS002
Date Current Plan Accepted 12/08/2016
Study Name Sampling and Culturing Study
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 Design Description 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 Description 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

Data Collection 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
Interim Safety Information As of the interim report dated November 1, 2018:



Total # of Samples Required: 850

# of Sites Enrolled: 2

# of Samples Analyzed: 205



# of Samples Positive for Low/Moderate Concern Organisms >100 CFU: 3/107 (2.8%)*

# of Samples Positive for High Concern Organisms: 3/107 (2.8%)*

* Pentax culturing results for subset of samples collected using sterile methods (“properly collected”).



# of Samples Positive for Low/Moderate Concern Organisms >100 CFU: 5/205 (2.4%) **

# of Samples Positive for High Concern Organisms: 21/205 (10.2%) **

** Pentax culturing results for all samples collected (including protocol violations collected using non-sterile methods). Because many of these samples were collected using non-sterile methods, FDA does not believe these data reflect real-world contamination rates.



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.



Sampling and Culturing Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
28 month report 03/30/2019    
29 month report 04/29/2019    
30 month report 05/29/2019    
31 month report 06/28/2019    
32 month report 07/28/2019    


  • The 522 Postmarket Surveillance Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated under section 522 of the Federal Food, Drug and Cosmetic Act. The program helps ensure that well-designed 522 postmarket surveillance (PS) studies are conducted effectively and efficiently and in the least burdensome manner.
  • In May 2008, the oversight responsibility of the 522 Postmarket Surveillance Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH). DEPI continues to build the 522 program.
  • CDRH has established an automated internal tracking system that efficiently identifies the reporting status of active 522 PS studies based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all 522 PS commitments are fulfilled in a timely manner.
  • In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each 522 PS study. The webpage displays general information regarding each study, as well as the overall study status (based on protocol-driven timelines and adequacy of the data) and the applicant's reporting status for each submission due.

Links

Contact Information

Cheryl Reynolds
Project Manager, 522 Postmarket Surveillance (PS) Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-2252
Silver Spring, MD 20993-0002

Phone: (301) 796-6068
Fax: (301) 847-8140
Cheryl.Reynolds@fda.hhs.gov
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