The US Food and Drug Administration has issued an alert over Medline beds for home and long-term care after two people died and 16 others were seriously injured by the product. The Northfield-based medical supply company said it was removing the beds from sale and exiting the market.
The FDA's Early Alert, issued Thursday, detailed a potential fire hazard. According to the agency, the electrical components in the beds have the potential to overheat, causing the casing to melt and potentially produce smoke or cause fires. Accessories such as mattresses and side rails were also flagged over the risk of entrapment or asphyxiation.
Medline issued its own alert earlier this month, saying it was removing the product from sale and exiting the market for the beds. “We believe this action best supports our commitment to product quality and safety for healthcare providers and the patients and communities they serve,” the company said. Medline said it recognizes the impact the decision may have on the healthcare system and is taking actions to support affected customers and minimise disruption.
For current product owners, Medline says the beds can still be used but suggests only plugging them in to reposition a patient and not using extension cords. Some beds may be able to be repaired; those that cannot will be eligible for a full refund or replacement. Customers can contact the company's recall service line to begin the process.
The FDA said it is continuing to review the matter and will keep the public informed as significant new information becomes available.
Analysis
Why This Matters
- Two people have died and 16 others were seriously injured in incidents involving the product, highlighting an acute safety failure.
- The products are used in vulnerable patient settings, specifically home and long-term care.
- Medline’s decision to exit the bed market entirely suggests the safety issues may be systemic to the product line.
Background
Medline is a Northfield-based medical supply company. The recall covers its range of beds and accessories used in home and long-term care settings. The FDA issued its Early Alert after the company flagged a potential fire hazard and a risk of entrapment or asphyxiation from accessories.
Key Perspectives
- FDA: Issued an Early Alert warning the public and is continuing to review the matter, stating it will keep the public informed as new information becomes available.
- Medline: States the decision best supports its commitment to product quality and safety, and that it is taking actions to support affected customers and minimise disruption.
What to Watch
- Whether the FDA escalates its alert to a formal recall or other enforcement action.
- The full extent of how many units are affected and the progress of the refund and repair process.
- Potential legal action from families of the deceased or injured patients.
Checked
12 claims in this story checked against 1 source: 11 supported.
Show each claim
- SupportedThe FDA issued an alert over a potential fire hazard in Medline beds.Chicago Sun-Times: “The U.S. Food and Drug Administration issued an alert about Northfield-based medical supply company Medline’s beds Thursday after two people died and 16 others were seriously injured by the product. The FDA issued an Early Alert warning Thursday about Medline beds”
- SupportedMedline is exiting the market for the beds.Chicago Sun-Times: “Medline issued its own alert earlier this month saying it was removing the product from sale and exiting the market for the beds.”
- Partly supportedMedline was aware of at least two deaths and 16 injuries.Chicago Sun-Times: “As of Oct. 20, the company said it was aware of at least two deaths and 16 injuries related to the products.”
- SupportedTwo people died and 16 others were seriously injured by the product.Chicago Sun-Times: “after two people died and 16 others were seriously injured by the product.”
- SupportedThe FDA’s Early Alert was issued Thursday.Chicago Sun-Times: “The FDA issued an Early Alert warning Thursday about Medline beds”
- SupportedThe beds’ electrical components could overheat, melt the casing, and produce smoke or cause fires.Chicago Sun-Times: “The beds’ electrical components have the potential to overheat, causing the casing to melt and produce smoke or cause fires”
- SupportedAccessories such as mattresses and side rails could entrap or asphyxiate patients.Chicago Sun-Times: “the related accessories have the potential to entrap or asphyxiate patients, per the alert.”
- SupportedThe company said, “We believe this action best supports our commitment to product quality and safety for healthcare providers and the patients and communities they serve.”Chicago Sun-Times: ““We believe this action best supports our commitment to product quality and safety for healthcare providers and the patients and communities they serve,” the company said in a statement.”
- SupportedMedline said it recognizes the decision’s impact on the healthcare system and is taking actions to support affected customers and minimise disruption.Chicago Sun-Times: ““We recognize the impact this decision may have on the healthcare system. Medline is taking actions to support affected customers and healthcare providers and to help minimize disruption while prioritizing patient safety.””
- SupportedMedline says owners can still use the beds, but should plug them in only to reposition a patient and should not use extension cords.Chicago Sun-Times: “For current product owners, Medline says they can still be used, but suggests only plugging in the beds to reposition the patient and not to use extension cords to power them.”
- SupportedSome beds may be repairable; beds that cannot be repaired are eligible for a full refund or replacement.Chicago Sun-Times: “Some of the beds may be able to be repaired, according to the alert, though those that aren’t will be eligible for a full refund or replacement.”
- SupportedThe FDA is continuing to review the matter and will keep the public informed as significant new information becomes available.Chicago Sun-Times: ““The FDA is currently reviewing information about this potentially high-risk device issue and will keep the public informed as significant new information becomes available,” the agency said in a statement.”