FDA issues highest alert about 9,000 high-tech hospital beds that could KILL patients: Smart mattresses first released in 2018 are recalled because they cause lifesaving medical equipment to malfunction
Thousands of high-tech hospital beds have been recalled amid concerns they could kill or cause life-threatening injuries to patients.
Smart beds have been found to interfere with nearby medical devices, including baby heart rate monitors, infusion pumps and other crucial equipment.
Illinois-based healthcare company Baxter International has initiated a recall of 8,550 units of its WatchCare continence management system.
They are mainly used in intensive care and operating rooms and alert caregivers when incontinence patients have had an accident. The faulty units were first released in August 2018.
Staff at hospitals where beds are used are urged to double check all unexpected or atypical results and monitor infusions closely.
The US Food and Drug Association (FDA) has classified the recall as ‘class one’, the most serious type.
The Centrella bed (bottom left), Progressa bed (top left) and VersaCare bed (bottom right) contain the WatchCare incontinence management system (white pad shown top right)
One of the affected smart beds is the Centrella P7900B bed with WatchCare
The WatchCare system for the Progressa bed may also interfere with medical equipment
The recall was based on 96 reports of interference with no reports of product-related injuries or deaths, the FDA said.
All but two of the 96 interference incidents occurred when the medical device was within three feet of the hospital bed.
The beds are believed to be used on a wide range of patients, from women in labor to people with dementia.
Baxter, one of the nation’s leading providers of hospital beds, notified customers of the recall in a letter in late September.
In the letter, Baxter warned users about the possibility of WatchCare’s radio frequencies interfering with other medical devices.
The correction letter was updated last month to include actions that healthcare professionals could take if they found any malfunction or interference.
The device was also found to interfere with insulin pumps, blood glucose sensors and bladder scanners.
Baxter said it sought the location and removal of the device from clinical care areas, where possible.
All hospitals with beds should identify all affected devices and stop use of the WatchCare system accessory while they resolve the cause of the problem, Baxter said.
In the meantime, the company will also contact users to coordinate the temporary deactivation of the accessory.
Physicians and patients experiencing adverse product-related reactions should report them to the FDA’s Adverse Event Reporting and Safety Information program via an online form, mail, or fax.
Health professionals should use ‘standard, non-radiofrequency based incontinence management pads’ until the problem is resolved.
Many of the recalled WatchCare devices were made by Hillrom, which was acquired by Baxter in late 2021.
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