Sam Brusco, Associate Editor11.28.22
The U.S. Food and Drug Administration has identified Baxter-Hillrom’s September 30th recall of its WatchCare incontinence management system (IMS) as Class I.
The technology includes certain Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. It discreetly alerts caregivers of an incontinence event and is typically used in critical care and medical-surgical settings.
The company recalled WatchCare IMS following of possible radiofrequency (RF) emissions interfering with other medical devices in the room, such as infusion pumps, insulin pumps, glucose sensors, fetal monitors/dopplers, telemetry devices, and bladder scanners. The FDA said other third-party devices can also risk being affected.
The RF interference may cause erroneous readings or malfunctions in the other devices, leading to inadequate treatments or lack of treatment.
To date, Baxter-Hillrom has reported 96 interference complaints, with all cases but two occurring at distances under one meter. There have not yet been reports of serious injuries or deaths related to the issue.
Baxter-Hillrom advised customers to remove affected devices where possible until the WatchCare functionality is disabled.
Altogether, 8,550 devices distributed between August 1, 2018 and September 1, 2022 were recalled in the U.S.
The technology includes certain Centrella, Progressa, and VersaCare hospital beds and disposable incontinence pads. It discreetly alerts caregivers of an incontinence event and is typically used in critical care and medical-surgical settings.
The company recalled WatchCare IMS following of possible radiofrequency (RF) emissions interfering with other medical devices in the room, such as infusion pumps, insulin pumps, glucose sensors, fetal monitors/dopplers, telemetry devices, and bladder scanners. The FDA said other third-party devices can also risk being affected.
The RF interference may cause erroneous readings or malfunctions in the other devices, leading to inadequate treatments or lack of treatment.
To date, Baxter-Hillrom has reported 96 interference complaints, with all cases but two occurring at distances under one meter. There have not yet been reports of serious injuries or deaths related to the issue.
Baxter-Hillrom advised customers to remove affected devices where possible until the WatchCare functionality is disabled.
Altogether, 8,550 devices distributed between August 1, 2018 and September 1, 2022 were recalled in the U.S.