Baxter Issues Urgent Medical Device Correction for WatchCare System
Baxter International put out an Urgent Medical Device Correction for its WatchCare incontinence management system because of the potential for radio frequency (RF) interference with other medical devices.
The WatchCare system uses smart technology integrated into hospital incontinence pads to alert caregivers of an incontinence event.
Although the company says the system was developed to comply with the most recent standards, the RF it emits could affect other devices in the vicinity, including wearable devices such as blood glucose sensors, insulin pumps, fetal monitors and general infusion pumps.
“This RF interference could result in erroneous readings or additional malfunctions of these other devices and could therefore result in inappropriate medical intervention,” the company said.
Baxter said users and facilities should “stop use of all WatchCare system accessories where possible until this functionality is temporarily disabled and while Baxter continues to work to determine the cause of this problem.”
No serious injuries or deaths have been reported, the company said.