(537 days)
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing can be used to cover and protect catheter sites and to secure devices to skin. Common applications include securing I.V. catheters, other intravascular catheters and percutaneous devices.
Tegaderm™ CHG I.V. Securement Dressing is intended to reduce vascular catheter colonization and catheter-related bloodstream infections (CRBSI) in patients with central venous or arterial catheters.
3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing is used to cover and protect catheter sites and to secure devices to skin. It is available in a variety of shapes and sizes.
Tegaderm™ CHG I.V. Securement Dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w Chlorhexidine Gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity.
The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria, and yeast, and protects the I.V. site.
In vitro testing (log reduction and barrier testing) demonstrates that the Tegaderm™ CHG gel pad in the Tegaderm™ CHG I.V. Securement Dressing has an antimicrobial effect against, and is a barrier to, a variety of gram-positive and gram-negative bacteria, and yeast in the dressing. The gel pad absorbs fluid.
Tegaderm™ CHG I.V. Securement dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
The device is single-use, provided sterile and the sterilization method is ethylene oxide. There are no associated accessories.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes the performance of the 3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing in reducing Catheter-Related Bloodstream Infections (CRBSI). While explicit "acceptance criteria" (i.e., pre-defined thresholds the device must meet to be cleared) are not stated in a tabular format, the study results demonstrate the device's efficacy, which served as the basis for its expanded indication.
Implicit Acceptance Criteria (Based on Study Findings supporting Expanded Indication):
| Metric | Acceptance Criterion (Implicitly met by demonstrated performance) | Reported Device Performance (Tegaderm™ CHG I.V. Securement Dressing) | Control Group Performance (non-CHG dressing) | P-value |
|---|---|---|---|---|
| CRBSI Reduction (Timsit Definition) | Statistically significant reduction in CRBSI rate | 0.96% (9/938 patients) | 2.2% (21/941 patients) | 0.020 |
| CRBSI Infections per 1000 Catheter Days (Timsit Definition) | Statistically significant reduction in CRBSI rate per 1000 catheter-days | 0.52 | 1.29 | N/A (derived from patient reduction) |
| CRBSI Reduction (IDSA Definition - Sensitivity Analysis) | Statistically significant reduction in CRBSI rate | 0.85% (8/938 patients) | 1.7% (16/941 patients) | 0.095 |
| CRBSI Infections per 1000 Catheter Days (IDSA Definition) | Statistically significant reduction in CRBSI rate per 1000 catheter-days | 0.46 | 0.94 | N/A (derived from patient reduction) |
| Percent Reduction in Patients with Infections (Timsit Definition) | Significant percentage reduction | 57% reduction | N/A | N/A |
| Percent Reduction per 1000 Catheter Days (Timsit Definition) | Significant percentage reduction | 60% reduction | N/A | N/A |
| Percent Reduction in Patients with Infections (IDSA Definition) | Significant percentage reduction | 50% reduction | N/A | N/A |
| Percent Reduction per 1000 Catheter Days (IDSA Definition) | Significant percentage reduction | 51% reduction | N/A | N/A |
Additional Performance Data Mentioned (In Vitro):
- Antimicrobial Effect: Log reduction and barrier testing demonstrate antimicrobial and antifungal effect against gram-positive and gram-negative bacteria, and yeast.
- Suppression of Regrowth: Demonstrated suppression of regrowth over time.
2. Sample Size and Data Provenance
- Sample Size for Test Set: The randomized controlled clinical trial included 1,879 subjects with 4,163 central venous and arterial catheters.
- Data Provenance: The study was conducted at 11 hospitals (12 ICUs) in France. The data is prospective, as it was a randomized controlled trial.
3. Number of Experts and their Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for diagnosing CRBSI within the study. However, the study authors (Timsit JF et al.) likely followed established clinical protocols and expert consensus for CRBSI diagnosis within a critical care setting.
4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). However, the definition of CRBSI used in the Timsit study (and subsequent re-analysis using IDSA guidelines) implies a structured diagnostic process based on clinical criteria and laboratory results. This often involves review by infectious disease specialists or hospital epidemiologists, though the specific adjudication process is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The study was a randomized controlled clinical trial comparing a medical device (dressing with CHG) to a control (dressing without CHG) in a real-world clinical setting, not assessing human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not done. The study evaluated the clinical effectiveness of a medical device (a dressing containing CHG) in a human-in-the-loop scenario (patients with catheters). There is no "algorithm" in the context of an antimicrobial dressing.
7. Type of Ground Truth Used
The ground truth used for determining CRBSI in the clinical study was based on clinical definitions of infection and laboratory confirmation. Two definitions were applied:
- Timsit et al. (2012) Definition: A specific combination of positive peripheral blood cultures, positive quantitative catheter-tip culture, and absence of other infectious foci. For coagulase-negative staphylococci, matching pulse-field gel electrophoresis patterns were required.
- Infectious Diseases Society of America (IDSA) 2009 Guidelines: A re-analysis incorporated IDSA's definition, which includes bacteremia/fungemia with an intravascular device, clinical manifestations, absence of other sources, and a combination of positive semiquantitative/quantitative catheter cultures or differential time to positivity.
8. Sample Size for the Training Set
The concept of a "training set" is not applicable here, as this is a medical device (dressing) and not an AI/ML algorithm. The study was a clinical trial evaluating the effectiveness of the dressing.
9. How the Ground Truth for the Training Set Was Established
As mentioned in point 8, there is no "training set" for this type of medical device. The clinical trial directly assessed the device's impact on CRBSI rates in patients.
N/A