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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS150004 / PSS002 |
| Date Original Plan Accepted |
12/08/2016
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| Date Current Plan Accepted |
12/08/2016
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| Study Name |
Sampling and Culturing Study
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| Device Name |
Duodenoscopes
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| Root Document Number |
K961568
K963056
K902710
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| General Study Protocol Parameters |
| Study Design |
Bench/Lab Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
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| 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.
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| 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.)
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| Sample Size |
Max # of Pilot
Install Samples Min # of Sample
Base per Scope Scopes Size .
=225 17 5 85
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| 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.
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| 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
Mitigations
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
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