On November 14, 2024, the US Consumer Product Safety Commission (CPSC) and Home 4U, Inc., dba. Medical King, of Brooklyn, New York, announced the recall of three models of Medical King Bed Assist Rail 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.
Medical King has received one report of a death involving the Bed Assist Rail with Adjustable Heights, model number 7007. In November 2023, at a residential care facility in South Carolina, a 66-year-old man died after becoming entrapped between his mattress and the bed rail.
This recall involves the Bed Assist Rail with Adjustable Heights (model numbers 7007 and 7057) and the Bed Assist Rail Without Legs (model number 7037). The Bed Assist Rail with Adjustable Heights is made of black or white metal tubing with a rounded black foam rubber grip handle and a fabric pouch. The Bed Assist Rail Without Legs is made of silver metal tubing with a black foam rubber grip handle and a black fabric pouch. There are no model numbers or brand-specific labels on the recalled bed rails.
Medical King sold about 222,000 of the recalled bed rails from January 2020 through March 2024 for about $40. The recalled bed rails were sold online via Amazon.com, Walmart.com, Target Plus, eBay, Kohls.com and medicalkingusa.com. They were manufactured in China.
Consumers should immediately stop using the recalled bed rails and contact Medical King for a free repair kit or a replacement bed rail, depending on the model.
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 Medical King for a free repair kit or a replacement bed rail. 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, Inc. for informational purposes only and is not intended to provide legal advice.*
