On May 30, 2024, the US Consumer Product Safety Commission (CPSC) and Medline Industries LP, of Northfield, Illinois, announced the recall of two models of Bed Assist Bar adult portable bed rails. The recalled bed rails pose a risk of entrapment and asphyxia because users can become entrapped within the rail, or between the rail and mattress.
Medline has received two reports of entrapment deaths associated with the Bed Assist Bars. The deaths occurred in July 2019 and November 2023 and involved a 76-year-old woman at a senior nursing facility in Iowa and an 87-year-old woman at a residential care facility in South Carolina.
The recalled bed rails have model numbers MDS6800BA and MDS6800BAH. The two models are identical, but model MDS6800BA was sold individually and model MDS6800BAH was sold in cases of three units. The bed rails are made of black metal tubing with a rounded black foam rubber grip handle and a fabric pouch. The name “Medline” and the model number are printed on a label located on the support frame of the bed rail near the vertical portion of the bed rail.
Medline sold about 1.5 million of the recalled bed rails from July 2009 through March 2024 for between $32 and $64. The recalled bedrails were sold through Medline’s websites, Medline.com and athome.medline.com, major online retailers including Amazon and Walmart.com, online pharmacies including CVS.com and Walgreens.com, and online medical supply stores nationwide including Cascade Healthcare Solutions and Magic Medical. They were manufactured in China.
Consumers should immediately stop using the recalled bed rails and contact Medline for a refund. Contact Medline toll-free at 866-359-1704 from 8 a.m. to 5 p.m. CT Monday through Friday, by email at recalls@medline.com, or online at https://recalls.medline.com or https://athome.medline.com and click on “Product Recalls” at the bottom of the page for more information.
CPSC urges consumers to report any related incidents to the agency at www.SaferProducts.gov.
Compliance Perspective
Issue
Facilities should immediately stop using the recalled bed rails and contact Medline for a refund. CMS F700 Bed Rails states that a facility must attempt to use appropriate alternatives prior to installing a side or bed rail. If a side or bed rail is used, the facility must ensure correct installation, use, and maintenance of the rails. CMS states in F909 that a facility must conduct regular inspection of all bed frames, mattresses, and bed rails (if any) as part of a regular maintenance program to identify areas of possible entrapment. When bed rails or mattresses are used and purchased separately from the bed frame, the facility must ensure that the rails, mattress, and bed frame are compatible. A bed gap analysis should be repeated each time a resident has a change of condition, receives a new mattress, or moves to a different bed. When recalls are issued, facilities should check to make sure they are not using any items listed in the recall.
Discussion Points
- Review policies and procedures for resident safety, including entrapment risks and bed safety checks. Update as needed.
- Train all appropriate staff on resident safety policies and procedures. Also train appropriate staff, including maintenance, on the proper procedures for bed safety checks. Document that the trainings occurred, and file the signed documents in each employee’s education file.
- Audit to make sure facility is not using recalled bed rails and that safety checks are being done regularly and correctly. You can obtain a useful resource for conducting entrapment risk checks for all beds, whether bed rails are in use or not, at this link: Guidance for Industry and FDA Staff – Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
*This news alert has been prepared by Med-Net Concepts, LLC for informational purposes only and is not intended to provide legal advice.*
