January 9, 2023
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Thank you for the opportunity to express our views on the Consumer Product Safety Commission’s (CPSC) proposed ruling of safety standards for adult portable bed rails (APBR).
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and products are most beneficial for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
NCHR strongly agrees with CPSC’s proposed ruling that APBR has an “unreasonable risk of injury and death associated with entrapment hazards” and enthusiastically supports CPSC’s plan to make the voluntary safety standards mandatory, include new requirements for testing and labeling, and consider banning the products if the new standards do not substantially improve their safety. Testing requirements focused on structural integrity and safety, such as assessing “the potential entrapment in four different zones”, will improve safety. In 2013, we strongly urged CPSC to make mandatory standards for APBR or ban these products, and although it is disappointing that it is taking 10 years to follow through, we appreciate CPSC finally taking this important step.1 We are confident that these mandatory standards, including tests and new labeling, will help prevent more APBR-related injuries and deaths.
From January 2003 to December 2021, 310 fatalities and 80,000 injuries were reported in the U.S. due to APBR; asphyxiation was the most common cause of death.2 Among the 80,000 injuries, the majority were head and neck related. Of those who died, 75% were older than 70 years. Elderly and frail individuals are the most likely to use APBRs and most likely to suffer from APBR-related injuries or deaths, especially those with dementia or limited cognitive function.1,3
We urge CPSC to hold manufacturers accountable for complying with these mandatory tests and standards and recommend monetary fines for manufacturers or recalls of products that do not comply, as CPSC did for the Endurance Hand Bed Rails in 2021.4 We also urge CPSC to develop and distribute an updated fact sheet for manufacturers to give to consumers, providing specific information about the 17 possible entrapment zones when using APBR, with emphasis on the top four zones. This fact sheet should be a resource that is easily accessible and written at the average U.S. reading level (8th grade) in English and other languages, so that it can be easily read and understood.
It is important to consider alternatives to APBR’s if it becomes necessary to ban them. If the purpose of APBRs is to help patients adjust themselves in bed, alternatives include bed trapezes and/or adjustable beds.3 Like any other medical device, bed trapezes and adjustable beds need to be used with the guidance of a healthcare provider to prevent misuse or injuries. To prevent falling out of bed due to tossing and turning, consumers may choose non-slip mattress pads.3 They could also create a barrier on the edge of the bed with cushion materials such as pillows under the fitted bedsheet. We agree with the National Consumer Voice for Quality Long-Term Care that another safe way to reduce the chances of injury from a fall is placing cushioned floor mats or other similar products on the ground next to the bed. The final alternative that we suggest, which was recommended by the Pennsylvania Patient Safety Authority, is installing Bed Exit Alarms (BEA) that alerts caregivers when patients try to leave their bed.5 These alarms alert caregivers of a potential fall as well as warning patients they are doing something that could harm them. Alarms can be especially useful for patients who become disoriented or have dementia.
References:
1.National Center for Health Research. Comments on Proposed Order “Requests for Ban or Standard on Adult Portable Bed Rails”https://www.center4research.org/comments-proposed-order-requests-ban-standard-adult-portable-bed-rails/ . July 30, 2013.
2. Consumer Product Safety Commission. Safety Standard for Adult Portable Bed Rails. Federal Register. https://www.federalregister.gov/documents/2022/11/09/2022-22692/safety-standard-for-adult-portable-bed-rails. November 9, 2022.
3.The National Consumer Voice for Quality Long-Term Care. Protecting Long-Term Care Consumers from the Dangers of Bed Rails. https://theconsumervoice.org/issues/other-issues-and-resources/dangers-of-bed-rails.
4. Consumer Product Safety Commission. Essential Medical Supply Recalls Adult Portable Bed Rails Due to Entrapment and Asphyxia Hazard; One Death Reported. https://www.cpsc.gov/Recalls/2022/Essential-Medical-Supply-Recalls-Adult-Portable-Bed-Rails-Due-to-Entrapment-and-Asphyxia-Hazard-One-Death-Reported. December 22, 2022.
5. Pennsylvania Patient Safety Authority. Bed Exit Alarms to Reduce Fall Risk. http://patientsafety.pa.gov/ADVISORIES/Pages/200409_14.aspx. September, 2004