Dive Brief:
- Medline is updating its instructions for using home care beds in response to two issues linked to injuries and deaths, the Food and Drug Administration said Friday.
- The company received reports of hand control pendants sparking, burning, melting, smoking and catching on fire. As of Dec. 18, Medline has reported 12 injuries and one death associated with the electrical safety risk.
- Medline also identified a risk of patient entrapment when using third-party accessories with the beds. The entrapment risk, which could lead to asphyxiation, has been linked to two injuries and one death.
Dive Insight:
The affected devices are AC-powered adjustable beds for medical use. A built-in electric motor and remote control allow the patient to adjust the height and surface contour of the bed. The electrical safety risk applies to five items in the Medline Basic Bed franchise.
To mitigate the risk, Medline asked customers not to operate beds above their weight limits, ensure none of the components are jammed, check that there is no obstruction to the movement of the bed and hang the pendant on the headboard or footboard when not in use.
Medline told customers to unplug beds and call for service if motors jam, the controls stop working or the pendant becomes hot. The FDA has recommended that affected beds be left unplugged from wall power unless adjustments that require electricity need to be made.
The other issue stems from the potential for non-Medline accessories or user error when handling the pendant to unintentionally cause the bed to adjust position. If that happens, the patient could be trapped between the bed and the accessory, leading to asphyxiation, serious injury and death.
The FDA said people with reduced monitoring, such as home care patients, are at increased risk because of delays in detecting and responding to entrapment incidents. Medline has asked customers to use only its own side rails and accessories with the beds.
The entrapment risk applies to the Basic Beds and Medline’s Medlite Homecare Beds.
