Dive Brief:
- The Food and Drug Administration has categorized Baxter’s recall of its WatchCare incontinence management system as a Class I event.
- Officials assigned the recall to the highest risk category because of the potential for radio frequency emitted from the system to affect the operation of medically necessary devices such as insulin pumps and fetal monitors.
- Baxter, which warned customers about the device last month, has received 96 complaints but no reports of serious injuries or deaths related to this issue.
Dive Insight:
The recall covers a system that integrates sensors and connected technology into hospital incontinence pads to detect moisture and alert caregivers. After acquiring the system in its takeover of Hillrom, Baxter learned that its product radiates radio frequency (RF) that may affect nearby devices and lead to outcomes including insulin overdoses and incorrect fetal heart tone readings.
Following Baxter's urgent notice to customers, the FDA categorized the recall as Class I, noting that it affects 8,550 devices distributed in the U.S. between August 2018 and September 2022.
Baxter has reported 96 complaints of interference, all but two of which occurred at distances of less than one meter. The company has insufficient data about the distance on the two interferences. None of the reports involve serious injuries or deaths but, given that the device fault could result in inappropriate medical treatment or lack of treatment, the FDA assigned the recall to its highest risk category.
The FDA notice reiterates the advice Baxter provided previously. Hospitals should stop using the system, and Baxter will contact customers to arrange for WatchCare functionality to be switched off.
