Adult portable bed rails — which are installed on the sides of beds to facilitate mobility and reduce the risk of falling — are advertised as safety devices for elderly people or those with medical conditions.
But they can also pose a safety hazard, creating a risk of entrapment that could lead to serious injury or even death. Several companies, as well as the Consumer Product Safety Commission, have recalled thousands of units in recent months, citing the risk of asphyxia and reports of deaths.
The independent federal agency is now urging Americans to stop using another brand of adult portable bed rails, cautioning against 10 specific models after reports of three deaths between 2006 and 2013.
The CPSC is warning consumers to stop using 285,000 bed rails that were manufactured and sold by two companies: Mobility Transfer Systems Inc. between 1992 and 2021, and Metal Tubing USA Inc. in 2021 and 2022.
The devices were sold by online retailers including Walmart.com, Amazon.com, MTSMedicalSupply.com, VitalityMedical.com and Alimed.com, as well as secondhand sites like Ebay.
The agency says at least three people died after becoming entrapped in one model of the bed rails, including a 78-year-old woman in a Michigan assisted living facility, an 85-year-old man in an Oklahoma nursing home and a 90-year-old disabled woman in California.
"CPSC evaluated the bed rails and found that consumers can become entrapped between the bed rail and mattress, or within portions of the bed rail itself, leading to asphyxia," it said in a Thursday statement.
It said neither company has agreed to recall the bed rails or to offer a remedy to consumers, adding that it is "assessing possible future action in this matter." NPR has reached out to both companies for comment.
The bed rails in question are made of white or chrome metal tubing, and have a label on the grip handle that displays the name "Mobility Transfer Systems" and a model number. The models are:
The agency is asking consumers to immediately stop using the bed rails, disassemble and throw away the devices, and to report any related incidents online.
Adult portable bed rails have been linked to hundreds of deaths and injuries
Many portable bed rails can be purchased online without the recommendation of a health care provider, while some are considered medical devices subject to U.S. Food and Drug Administration oversight, says the FDA, noting that all should be used with caution.
"Adult portable bed rails and hospital bed rails are not for everyone, nor every situation," the agency states on its website. "Even when portable bed rails and hospital bed rails are properly designed to reduce the risk of entrapment or falls, are compatible with the bed and mattress, and are used appropriately, they can present a hazard to certain individuals, particularly to people with physical limitations or altered mental status, such as dementia or delirium."
The FDA says it received reports of seven deaths associated with portable bed rails between 2005 and 2013. It also tracked 901 incidents of patients being "caught, trapped, entangled or strangled" in hospital beds — including 531 deaths — between 1985 and 2013.
Meanwhile, the CPSC reviewed 260 incidents — 247 of which were fatal — involving adult portable bed rails between January 2003 and December 2019, according to an 2020 briefing. The vast majority of incidents were related to rail entrapment, while others were associated with falls, structural integrity and miscellaneous issues.
"CPSC staff's analysis found that the overwhelming majority of the reported decedents were age 70 or older," it wrote, referring to those who had died. "In addition, the majority of incidents involved victims with underlying medical conditions."
The commission also estimates that some 196,848 people were injured by adult portable bed rails between 2003 and 2019 — an average of about 11,579 people per year.
The FDA encourages people who are considering bed rails to make sure they understand who should use them and at what risk, and to be sure to install and use the devices properly.
There are alternatives to bed rails, as the advocacy organization National Consumer Voice points out. The other options include lowering the bed as close to the floor as possible or investing in an adjustable-height bed; placing non-slip mattress pads or cushions alongside the bed for potential falls; and using a secured vertical pole or bed trapeze to assist with getting in and out of bed.
Consumer groups have long campaigned for a federal ban or safety standard
There are federal efforts underway to better regulate these products, which consumer advocates have been demanding for years.
Here's a brief history of that process, according to a CPSC document from March of this year.
Back in 2013, the commission received two separate requests (one from the Public Citizen Health Research Group and one from a coalition of more than 60 consumer organizations) to address the hazards posed by adult portable bed rails, which it combined into a single petition.
It voted to defer action on that petition in 2014 and 2015, while the independent standards organization ASTM was working to develop a voluntary standard for adult bed rails. It published those standards in August 2017. The following year, the CPSC said it planned to test 35 randomly selected models to determine whether they met the new guidelines.
They came to a grim conclusion in 2020: While the voluntary standard adequately addresses the product's known hazards, there was "little-to-no evidence" that manufacturers were complying with it.
"Despite staff's outreach efforts, several product recalls, and the additional time allowed manufacturers to comply with the voluntary standard, fatal entrapment incidents continue to occur, as demonstrated by incident data," it said.
As of this spring, the CPSC has recorded an average of 16 fatal incidents related to adult portable bed rails each year. It says that 92% of those are related to entrapments — "which staff has found would likely be eliminated in products that comply" with the ASTM voluntary standard.
As such, CPSC staff recommended that the commission grant the original petition requiring a ban or standard.
Commissioner Rich Trumka Jr. announced in mid-March that the body had officially voted to start working on a formal federal rule to address the safety risk posed by adult portable bed rails, which he said "have trapped and strangled older adults at alarming rates."
"In the time period between when the petition was submitted and the Commission granted it, at least 129 people were killed by adult portable bed rails," Trumka added, calling this the "right decision to protect older Americans" and encouraging public health groups to continue bringing issues to the commission's attention.
Copyright 2022 NPR. To see more, visit https://www.npr.org.