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| General |
| Study Status |
Completed |
| 522 Number / Requirement Number |
PS150003 / PSS002 |
| Date Original Plan Accepted |
11/22/2016
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| Date Current Plan Accepted |
11/22/2016
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| Study Name |
Sampling and Culturing Study
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| Device Name |
Duodenoscopes
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| Root Document Number |
K853585
K954451
K024033
K080403
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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 |
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.
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| 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.).
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| Sample Size |
The pilot study will be conducted in approximately four sites which have access to all five duodenoscope models listed.
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| 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.
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| 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
Mitigations
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
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