The US Consumer Product Safety Commission (Commission or CPSC) published a final rule in the Federal Register on July 21, 2023, after determining that there is an unreasonable risk of injury and death associated with entrapment and other hazards from adult portable bed rails (APBRs). The rule is effective on August 21, 2023.
In 2013, the CPSC received two requests to initiate rulemaking proceedings under the Consumer Product Safety Act (CPSA) to address an unreasonable risk of injury associated with APBRs. The petitioners stated that many of the deaths and injuries involving APBRs resulted from asphyxiation caused by entrapment within openings of the APBR rail or between the rail and the mattress or bed frame. The petitioners requested that the CPSC initiate rulemaking proceedings under section 8 of the CPSA to ban all APBRs. Alternatively, the petitioners requested that the Commission initiate a rulemaking under section 9 of the CPSA to promulgate mandatory standards, including warning labels, to reduce the unreasonable risk of asphyxiation and entrapment posed by APBRs. Petitioners also requested action under section 27(e) of the CPSA to require manufacturers of APBRs to provide performance and technical data regarding the safety of their products.
CPSC identified 284 fatal incidents related to entrapment by APBRs between January 2003 and December 2021. To address the risk, the Commission promulgated a rule under the CPSA to require that APBRs meet the requirements of the existing voluntary standard for APBRs, with modifications. CPSC estimates that the final rule will provide up to $298 million per year in societal benefits, while the costs associated with the rule’s requirements are expected to be approximately $2 million per year.
Access the final rule here.
Compliance Perspective
Issue
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.
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 bed 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.*
