When the nurse entered the room, she was stunned. Before her lay the lifeless body of an elderly patient who had fallen out of bed. The woman's head was lodged between the mattress and a bed rail, a device designed to increase mobility and independence.
"I couldn't believe what I was seeing," said the nurse, who discovered the body in a long-term care center and retirement community in Decatur, according to a 2012 inspection report issued by the Illinois Department of Health. "The rail was pressed against her right ear and her face was into the mattress."
Federal agencies have known for decades that bed rails can injure or kill elderly patients who get stuck and are too sick, confused or feeble to free themselves. Serious harm also can occur when patients climb over rails and fall or when rails are used as a restraint, especially for those with dementia or anxiety.
The Food and Drug Administration, which regulates bed rails that qualify as medical devices, has received 901 reports of patients caught, trapped, entangled or strangled in hospital bed rails, including 531 deaths, since 1985. The Consumer Product Safety Commission has collected reports of 160 incidents related to portable bed rails — including 155 adult fatalities — between 2003 and 2012.
In Illinois, state and federal regulators have cited at least 10 nursing homes since 2011 for placing patients at risk of entrapment or suffocation, failing to protect residents from injuries related to bed rails and for using bed rails as restraints, according to a Tribune review of state inspection reports. Illinois health officials don't specifically track deaths linked to bed rails.
Under federal law, bed rails for young children must meet specific safety requirements, but those for adults aren't held to the same standard. Even when products have been associated with the death of an elderly patient, they have not been recalled or taken off the market.
"Issues that affect the elderly are not seen as important as those that affect children," said patient advocate Gloria Black of Portland, Ore., who has been campaigning for safer bed rails since her 81-year-old mother suffocated in a 2007 accident. "At some level, they think, 'Well, they were going to die anyway.' But that's not a way to treat the elderly."
After years of pressure by advocacy groups, the FDA and the CPSC last month announced that ASTM International, an organization that develops standards for industry, would begin the process of creating voluntary guidelines for adult bed rails that are not medical devices.
Bed rails, sometimes called side rails, are meant to help patients turn, pull themselves up or get out of bed. Made of metal or plastic bars, rails may be raised and lowered; those called bed handles stay in place. On one website, customers can select from about 50 types of safety rails with prices ranging from $29 to $180.
Of particular concern to consumer advocates are portable bed rails, which can attach to almost any bed. (In hospitals, rails are usually part of an integrated bed system.) As consumer products, such items are under the jurisdiction of the CPSC. Critics say this type often doesn't fit snugly to the mattress, which can create dangerous gaps.
Patients have died when their neck or chest becomes compressed between the rail and the bed, according to research published by Steven Miles in the Journal of the American Geriatrics Society.
In some cases, the patient can't inhale, said Miles, a professor at the Center for Bioethics at the University of Minnesota who in 1995 became one of the first to alert federal regulators to deaths involving bed rails.
"They can't even scream; air is squeezed out of the lungs," he said. "The problem is worse because this mostly happens to small people who can go into slots between the mattress and the rail. They don't have the strength to extricate themselves or are confused and demented."
In 2008, a 99-year old resident of Rest Haven Central in Palos Heights who had severe dementia and was a high fall risk died of "compressional asphyxia, due to trapping between the bed rail and the mattress," according to a state inspection report. A medical examiner found that compression also fractured a bone in her neck, the report said.
The facility, now owned by Providence Life Services and operating under a different name, reworked its protocols for side rail assessments and removed the rails if the patient agreed. Those who wanted the rails for mobility could keep them with a doctor's order, according to the report.
A spokeswoman for the company did not return calls for comment.
Some consumer advocates say portable adult bed rails are inherently dangerous and that it is not possible to create acceptable safety standards; the consumer advocacy group Public Citizen filed a petition this year asking the CPSC to ban them.
Separately, Black and a coalition of more than 60 organizations filed a petition in May that calls for the CPSC to recall and ban portable adult bed rails — or, in lieu of a ban, to set safety standards.
CPSC spokesman Scott Wolfson said the agency cannot create mandatory rules unless all other options — including voluntary consensus standards — have been pursued.
As of August 2012, bed rails for children must meet federal safety standards that CPSC put into effect under a federal law passed a few years earlier in response to a Tribune investigation of dangerous toys and other children's products.