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.
Bed Handles Inc., based in Blue Springs, Mo., makes the Bedside Assistant, a portable bed rail marketed as a way to help people get in and out of bed. In 2011, Public Citizen filed a petition asking the FDA to recall it and similar products, saying the FDA's adverse events database showed it was associated with at least four deaths.
Company owner Bon Shaw developed the bed handles to help his wife, who struggled with multiple sclerosis and has since died. He said the handles give people a degree of much-needed independence and freedom in a difficult time and said he has added a safety strap to help prevent accidents, among other adjustments.
"People will die using this or another bed rail type product," Shaw acknowledged. "But there is a significant risk even without a product involved. We're dealing with a very fragile and vulnerable population. But I have many cards and letters from people, saying it has changed their lives."
Some say bed rails can make sense in the right context, but much depends on the patient and how the rails are used. Connie Wilcosky of OSF Home Care Services in Peoria said she recently had an 80-year-old patient fall on his way to the bathroom in the middle of the night. The man didn't realize he'd gotten out of bed. As a reminder and to help him get to his feet safely, his daughter purchased a bed rail.
"Now he says that when he wakes, he sits at the side of the bed for a minute and has the bed rail to safely assist him to his feet," said Wilcosky.
Mary Kay Maas, of Chicago, who has a seizure disorder, had two half-rails placed on her bed after four consecutive episodes led to a concussion and monthlong hospital stay.
"They've proven to be a lifesaver in preventing her from hitting her nightstand if and when a seizure occurs," said her sister, Nancy Spillo, a home care nurse for Presence Home Care Services. "They have their place for safety but should not be used merely as a restraint."
It may seem sensible to use bed rails to restrain people from falling out of bed, but "putting up barriers isn't something that's been found to be effective," said geriatric nurse researcher Elizabeth Capezuti, a professor of aging at the New York University College of Nursing.
In fact, patients can be more seriously injured in a fall after climbing over bed rails because of the longer drop to the ground, she said. Capezuti's own work has found that falls do not increase when side rails are removed.
Illinois officials cited Morton Villa HealthCare and Rehabilitation Center last year for using side rails without a medical need for five patients. In one case, the patient went over the side rail and landed on the floor, suffering femur and wrist fractures.
A spokeswoman for Morton Villa, , near Peoria, declined to comment on the facility's use of bed rails.
In home settings, family caretakers sometimes use bed rails to keep their charges in bed because "they don't know what else to do," said Beryl Goldman, director of Kendal Outreach, a nonprofit that works to educate health care professionals about restraint-free care.
The best way to keep vulnerable people safe from falls, some experts say, is to watch them vigilantly, lower the bed if possible and place a mattress or padding on the floor.
In 2006, after seven years of discussion, the FDA established voluntary guidelines for bed-rail use in hospitals and nursing homes but stopped short of requiring warning labels. Entrapment reports decreased from 85 in 2005 to 40 in 2010, according to the agency.
Both the Centers for Medicare & Medicaid Services and the Joint Commission, which accredits health care organizations, prohibit the use of restraints, which includes bed rails. Medicare, meanwhile, no longer pays for the treatment of falls from bed or bed-rail entrapment.
Today, most hospitals and long-term care facilities have policies prohibiting the use of four rails at once, which is considered a restraint. Instead they might use two short side rails near the head to help increase mobility, in conjunction with a doctor's order.
In Decatur, Fair Havens Christian Home made changes to its protocols after the elderly woman's death last year, according to the state inspection report. Ellen O'Neil, vice president of nursing for Christian Homes, which owns 14 facilities in four states, including Fair Havens, said patient confidentiality rules prevented her from commenting on specific cases.
"We do use side rails as an aid to assist with mobility and we don't use them as a restraint," said O'Neil. "Each resident is assessed individually to determine whether they are medically necessary. They are usually used to promote independence."
Ronald Shorr, who directs geriatric research at the Veterans Affairs Medical Center in Gainesville, Fla., said rails can provide a false sense of security to nursing staff, in part because patients who feel confined may struggle and fight, leading to injury.
"Things that are meant to be safe may actually increase the risk," Shorr said.