Dive Brief:
- Baxter issued an Urgent Medical Device Correction after learning its WatchCare incontinence management system can interfere with other medical devices.
- The device radiates radio frequency (RF) that may affect nearby devices, causing insulin overdoses, incorrect fetal heart tone readings and other errors.
- Baxter, which acquired WatchCare in its takeover of Hillrom, has asked facilities to stop using the affected devices if possible until the functionality is temporarily disabled.
Dive Insight:
The WatchCare system integrates sensors and connected technology into hospital incontinence pads to detect moisture and alert caregivers. In a study at a 36-bed med-surg unit, the system reduced the time that patients’ skin was exposed to moisture from two hours to 19 minutes.
According to Baxter, the system complies with the most recent RF standards. Still, the company has received reports of interference. In most cases, the interference involved devices within 1 meter of the system. Baxter has insufficient data on the distances involved in the other two cases. RF interference may affect insulin pumps, fetal monitors, telemetry devices, bladder scanners and infusion pumps.
Baxter has asked users to switch to standard, non-RF-based, incontinence management pads until it fixes the problem. If sites are still using the technology, they should double check all unexpected results and monitor infusions closely. Baxter is validating the impact WatchCare may have on nearby devices and looking into ways to improve the product.
The Food and Drug Administration shared Baxter’s urgent notice, while it hasn’t yet taken any action. Baxter’s notice states that the problem could cause serious harm or death — the criteria for a Class I recall — by affecting the operation of blood glucose sensors, insulin pumps, fetal monitors and general infusion pumps.
