After learning that its WatchCare incontinence management system can conflict with other medical devices, Baxter has issued an Urgent Medical Device Correction. The device emits radio frequency (RF) that could interfere with nearby devices, leading to insulin overdoses, inaccurate readings of fetal heart tones, and other mistakes.
Hospital incontinence pads equipped with the WatchCare system have sensors and connected technologies that can detect moisture and notify caretakers. The technology decreased the amount of time that patients’ skin was exposed to dampness in a study at a 36-bed medical-surgical facility ranging from 120 minutes to just 19 minutes. The system complies with the latest RF standards, claims Baxter. Nevertheless, the business has been notified of meddling. The interference most frequently affected objects that were less than 1 meter from the system. Regarding the distances involved in the other two cases, Baxter lacks sufficient information to verify the claim. The following list, provided in a statement from the FDA, refers to equipment that has been found to affect RF interference to a certain degree:
- Insulin pump/blood glucose sensor: Sensor readings can be affected and result in overdosing of insulin related to incorrect high glucose readings; as a precaution, users should be vigilant of any erratic or incorrect (high or low) glucose level(s) or insulin dosing events
- Fetal monitor/doppler: May cause “phantom” incorrect fetal heart tone readings up to 200 bpm; as a precaution, users should be vigilant of any erratic or incorrect (high or low) fetal heart tones
- Telemetry devices: Could cause telemetry “artifact” of unknown specificity; as a precaution, users should be vigilant of any telemetry rhythm displays that do not match patient’s clinical presentation
- Bladder scanner: May cause interference of unknown specificity; as a precaution, users should be vigilant of any potential false (elevated or low) residual urine volume readings
- Infusion injection pump: May cause interference of unknown specificity; as a precaution, users should be vigilant of any erratic or incorrect dosing events
Users of the incontinence pads have been advised to switch to conventional incontinence control pads without RF technology until Baxter can resolve the issue. If sites are still use the technique, they should carefully watch infusions and double-check any unexpected findings. Baxter is investigating ways to develop the product while validating the potential effects WatchCare may have on nearby devices.