Product Overview

ivWatch 400 (ivWatch LLC, Hampton, VA, USA) is intended to detect infiltration events in patients with peripherally inserted IVs and produce auditory and visual alarms to notify clinicians and notify them sooner than clinician observation can detect. IV infusion pumps, which clinicians must routinely monitor, are not equipped with alarms for infiltrations (for more information, see ECRI Guidance for Infiltration during Infusion Therapy: Why It Occurs and How to Prevent It). ivWatch uses a sensor placed near the inserted IV and emits visible and near-infrared light through a patient's skin to detect reflected light. ivWatch detects changes in reflection due to accumulation of subcutaneous fluid that is detected as an infiltration event. (See the manufacturer's website for more information.) The amount of light the sensor detects depends on the tissue's scattering and absorptive properties. When infiltration occurs, the optical scattering properties purportedly decrease because of fluid in the subcutaneous tissue. Yellow or red notifications are displayed on the monitor; yellow notifications indicate possible infiltration, and red notifications indicate probable infiltration. A notification's intent is to prompt clinical assessment of the IV site and catheter function to ensure proper sensor placement; that the IV line flushes without resistance, swelling, or pain; and to assess whether redness or leakage is present.

ivWatch consists of a display monitor, a reusable sensor cable, and a disposable sensor receptacle. A clinician first plugs the sensor cable into the monitor and follows a series of on-screen commands to begin monitoring. The clinician attaches a sterile sensor receptacle to the sensor cable and positions the receptacle on the patient, within one inch of the inserted catheter tip. The clinician covers the catheter with occlusive dressing, according to facility protocols, without covering the sensor receptacle. The monitor displays a yellow or red screen that states “Check IV" when a possible or probable infiltration is detected, respectively. The clinician uses the monitor controls to confirm that the IV has been checked and to review monitoring history. (For additional information see the ivWatch user manual.)

Regulatory Status

FDA granted 510(k) marketing clearance for ivWatch 400 for patients 18 years of age or older in February 2015 (K142374). FDA granted the ivWatch Model 400 an updated clearance to include pediatric patients) in December 2016 (K162478). The labeled indications are as follows:

The ivWatch Model 400 is indicated for the detection of subcutaneous infiltrations and extravasations of 10 cc or less of optically clear infusates, as an adjunctive device to the clinical evaluation in the healthcare setting of adults and pediatrics with peripherally-inserted catheters (PIVs). The device is indicated to assess patients for subcutaneous infiltrations and extravasations but should not serve as a substitute for regular clinician assessment of the PIV site. The ivWatch Model 400 is intended for use by healthcare practitioners who have been trained in the use of the device.

Clinical Literature

We searched PubMed, EMBASE, and selected web-based resources for all available literature published through September 3, 2019. Our search strategies included the following keyword: IvWatch. Please see the Selected Resources and References section for detailed search strategies. We identified and reviewed full text of 1 diagnostic cohort study (n = 213) that assessed ivWatch's clinical validity for detecting infiltration events in pediatric patients receiving continuous PVC infusions. Clinician-confirmed infiltrations served as the reference standard; however, the study reported only on sensitivity (not specificity, positive predictive value, or negative predictive value).

The study allocated patients to 2 groups: those with ivWatch alarms enabled (n = 57) and those with alarms disabled (n = 156). Authors also reported the time difference between ivWatch and clinician detection of infiltrations in the disabled-alarm group.(1) See Table 1 for a study summary.

We identified no studies assessing ivWatch's clinical utility. ivWatch's original FDA 510(k) premarket notification summary (K142374) mentions six Institutional Review Board–approved ivWatch studies but does not provide data for these studies; our searches identified no publications for these studies.

Evidence Limitations

The sole study is at risk of patient selection bias because of small sample size and at high risk of bias due to single-center focus and lack of blinding to the patient's other clinical information. Authors do not report whether they enrolled consecutive patients or a random sample of patients. The study did not report on ivWatch's specificity or on patient-oriented outcomes. Most catheters were positioned in patient's hands and forearms, and findings may not generalize to foot or leg infiltrations.

Ongoing Trials

Our search of ClinicalTrials.gov did not identify any ongoing clinical trials assessing ivWatch.

Safety

We searched ECRI Institute's Health Devices Alerts database and FDA's Manufacturer and User Facility Device Experience (MAUDE) database for product-specific alerts or recalls and adverse events. We identified no relevant information.

Table 1. Product-specific Clinical Literature