Archive photo: An electric hospital bed, not an identified recalled Medline model. Blogotron / CC0; cropped.
The Food and Drug Administration’s early safety alert covers Medline’s October 14 customer safety notice, updated October 24, concerning all Medline-brand beds and associated accessories and potential fire and entrapment hazards.
The FDA alert covers homecare, bariatric and long-term-care beds, as well as their hand-control pendants, accessories, replacement parts and bed-containing order packages. The reported deaths and serious-injury count was current as of October 20, according to the agency. The alert does not establish that the beds caused every reported event.
Medline is discontinuing and exiting the market for the affected products. But updated instructions allow beds, rails, mattresses and accessories to remain in use under specified precautions until they are repaired or replaced. The action does not cover every manufacturer’s hospital beds.
What patients, families and facilities should do
The FDA says Medline’s updated instructions call for users to unplug affected beds from electrical outlets. When a necessary adjustment is needed, plug the bed in while repositioning the patient, then unplug it when the patient is not being repositioned.
Do not use extension cords to power the bed. Whenever possible, have a second person available to help with using and moving it. Users should not attempt repairs, modifications or alterations unless Medline specifically directs them through an authorized repair process.
The agency says some beds may qualify for repair. Where repair is not available, Medline will work with customers to determine eligibility for a replacement or a full or partial refund. Those remedies may be available for certain beds, rails, mattresses and accessories purchased in the past five years. Older products are still covered by the field action and updated safety instructions.
Customers can call Medline Recall Customer Service at 800-950-0128, option 7 to start the applicable process or ask about affected products. The FDA links a full list of affected products from its alert.
Why the FDA is warning users
According to the FDA, electrical components can overheat under conditions that include excessive loading, jammed motors or components, damage or fluid entering the pendant, extension-cord use, or unapproved pendants and accessories. Overheating can progress to smoke, sparks, melting, burning or fire, with a risk of shock, burns, serious injury or death.
The agency also describes potential entrapment or asphyxiation risks involving accessories, loose or wobbly rails, or a user lying on a pendant.
Medline sent an initial customer safety notice on October 14 and updated its recommendations on October 24, the FDA says. The agency says it continues reviewing information about this potentially high-risk device issue. The early alert is not a final FDA recall classification.
For families caring for someone at home and for long-term-care facilities, the immediate task is to identify the bed and accessories and follow the updated instructions while arranging the appropriate remedy. The FDA says it will update its alert page as significant new information becomes available.
JBizNews Desk | Washington
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