Death beds: Siderails are killers — and little is being done to make them saferEditor's note: This story originally appeared Oct. 25, 1998.
By: Kendra Rosencrans and Craig Lincoln, Duluth News Tribune
Editor's note: This story originally appeared Oct. 25, 1998.
Older people are dying needlessly in nursing homes every year, strangled or suffocated by the bed siderails that are supposed to protect them from injury.
At least 10 people have died in bed siderail accidents in Minnesota and Wisconsin nursing homes since 1996, state records show. Officials in Minnesota are investigating two other deaths that could have been caused by siderails.
Nationally, 74 such deaths were reported to the federal government between 1993 and 1996.
A News-Tribune analysis of national death records suggests that the number of deaths related to these beds could be considerably higher.
No one knows exactly how big the problem is or how many people die annually in bed siderail accidents. The federal General Accounting Office has concluded that many deaths go unreported.
The problem itself is quite well known, however.
Medical researchers have known since the 1970s that people strangle or suffocate in siderails. Government regulators and bed manufacturers have known of the danger since at least the mid-1980s. And manufacturers, regulators and nursing homes have known since the 1950s that siderails often don't even do what they were designed to do: keep people in bed.
Yet, despite clear evidence that these devices are killing people, federal and state regulators only recently have begun to pay attention to the threat that the beds and siderails pose.
``The government is asleep on this,' said Steven Miles, a University of Minnesota physician and bioethicist who practices geriatric medicine at Regions Hospital in St. Paul. ``I think it's a terrible scandal that precisely measures the degree of bias against institutionalized older people."
Common beds, common devices
The beds and siderails in question are in hospitals and nursing home throughout the United States.
They're used primarily to help people adjust themselves in bed or to keep them from falling out of bed.
Some siderails extend the full length of the bed; others, called half siderails, are about 2 1/2 feet long. Some are metal, others are plastic. Most can be raised and lowered.
Siderails are divided, either vertically or horizontally, with slats spaced about six or more inches apart.
That is the deadly part of the design. The space is just big enough to trap an elderly person's head, causing him or her to strangle.
Some beds, mattresses and siderails are designed to fit together. But more commonly, according to a number of nursing home administrators in Northeastern Minnesota, the pieces are bought separately over several years as equipment wears out. Often mattresses fit loosely in the frame, leaving gaps large enough to trap a frail elderly person between the mattress and siderail, leading to suffocation.
Clinical researchers have been raising questions about the merits of bed siderails since the 1930s.
However, while some researchers have studied the risks and benefits of siderails, few have scrutinized their design, said Miles, who has studied this problem in his work at the University of Minnesota.
But in 1992, the federal Food and Drug Administration warned hospitals, nursing homes and emergency rooms about the dangers of using physical restraints on patients.
Three years later, in 1995, the FDA sent a safety alert to 94,000 hospitals, nursing homes, hospices and home-care agencies to warn them specifically about deaths due to siderails. That warning included a diagram that identified dangerous gaps and openings on hospital beds and siderails.
The FDA also instructed health-care facilities to inspect all beds and siderails.
``Alignment of the bed frame, bed siderail and mattress should leave no gap wide enough to entrap a patient's head or body,' the 1995 warning letter said.
The FDA took no action then other than to encourage health-care facilities and bed manufacturers to resolve the design problems while noting that ``currently, no universal standards exist for design of hospital bed siderails.'
While the FDA warning applied to every facility that uses siderails, the issue was of special concern to nursing homes, which are not as heavily staffed as hospitals and have populations of frail, elderly patients.
Health Care Financing Administration, the federal agency that regulates nursing homes, issued guidelines on bed siderails in 1997.
HCFA told nursing homes that they should be familiar with the FDA's 1995 warning that siderails can be deadly. The HCFA letter also gave nursing homes guidelines to follow when deciding whether to use them.
A HCFA newsletter to nursing homes in 1997 also included this warning:
``(E)ven when a bedrail is not being used a restraint, the assessment of its value for the resident must include the consideration of the potential accident hazard that bedrail use always presents,' HCFA said.
A different reaction
While Philip J. Poirer's wife was in the nursing home, he lived in fear that she would slip between the mattress and siderail on her bed and die.
She had become trapped between the mattress and siderail once and was injured, Poirer said.
The problem reminded Poirer, a retired industrial electrician from Cloquet, of the dangerous baby cribs of years past.
``The bed had too wide spaces,' Poirer said. ``Why don't they do the same thing as they did with baby cribs and put a barrier in there? The bed is the fault.'
The design problems with bed siderails have reminded others of baby cribs, and the FDA admits that it's a fair comparison.
However, the federal response to problems with cribs and other beds for children has been dramatically different.
In the early 1970s, when the U.S. Consumer Product Safety Commission estimated that 200 infants were dying annually in cribs with loose-fitting mattresses or side slats, it took action.
The consumer protection agency recalled dangerous baby cribs and forced the industry to adhere to new standards.
The CPSC is now considering new mandatory standards for bunk beds because of reports that children are getting caught and killed in the siderails.
``I think (the comparison to cribs) is a valid point,' said Larry Kessler, director of the Office of Surveillance and Biometrics in FDA's Center for Medical Devices and Radiological Health in Baltimore. ``It's a little more complicated in the siderail case than the distance between posts or rails in a baby crib. (But) it's not unreasonable to suggest that.'
To issue a recall, the FDA would need evidence that a specific brand of siderail was particularly deadly, Kessler said.
Because FDA officials believe that the benefits of using siderails outweigh the risks, a wholesale recall is out of the question, Kessler said.
``There would be such an enormous amount of morbidity and mortality by not using bed siderails. You can't imagine what would happen by taking them totally out of hospitals and nursing homes en masse,' Kessler said. ``It would be criminal for us to do that.'
The federal government's aggressive approach to crib safety contrasts sharply with its efforts concerning nursing home beds and siderails. The FDA is working with manufacturers and industry groups to develop voluntary design standards for hospital beds and siderails, Kessler said.
That method, which the FDA admits is slow, frustrates Miles of the University of Minnesota.
``You can work through international bodies, but we didn't do that for car airbags and we didn't do that for cribs that hung kids,' Miles said. ``It's a terrible double standard.'
One reason that government and industry have been slow to move is that the scope of the problem has not been clear. Many siderail deaths never show up in the records designed to track the safety of beds and other medical equipment.
Last year, Miles published a study of 74 deaths that were reported to the U.S. Consumer Product Safety Commission between 1993 and 1996.
Another study published in 1997 found that 72 siderail deaths were reported to the FDA between 1985 and 1995.
The FDA's reporting system is supposed to track injuries and deaths from medical devices, but the system has many flaws, the U.S. General Accounting Office concluded in a report to Congress last year.
Although required by law to report deaths and injuries due to medical devices, hospitals, nursing homes and other facilities ``did not report 5,000 device-related deaths to the FDA between fiscal years 1992 and 1995,' the report said.
Without those reports, ``the FDA's adverse event reporting system has significantly less information about medical device problems to use in identifying problems and assessing the public health risk,' the GAO report said.
Even when reports are filed with the FDA, they are often so poorly documented that they are almost useless, a News-Tribune analysis has found.
In looking at the FDA's database from 1995 through early 1997, the News-Tribune found many reports of deaths linked to bed siderails that were unclear or kept information secret from the FDA. Some examples, taken from reports to the FDA that did not name or locate specific facilities:
*In an October 1995 report, a nursing assistant found a patient by the bed in a kneeling position, legs and abdomen between siderail and bed, the mattress of the bed pushed aside.
``Physician, who is the facility's medical director, stated that death was of natural causes with unusual positioning,' the record of the incident stated.
*From a July 1996 report: ``Resident found lifeless body partially off the bed between the siderail and headboard.'
The bed's manufacturer, Joerns Healthcare, called the facility for more information. The facility, which wasn't named in the database, responded that ``all is confidential, no further information would be released. No photos taken of scene. Autopsy/coroner's report, none.'
While it's difficult to track injuries and deaths due to siderails and other medical devices now, the problem may get more difficult in the future.
Congress has ordered the FDA to lift the requirement that all health-care facilities report problems with medical devices. By Nov. 21, 1999, the agency must design a reporting system that will use a few facilities as a representative sample of all facilities that use medical devices.
The FDA says reporting by a few, trained facilities will improve tracking.
Miles says he fears such a change will make already underreported problems, such as siderail deaths, statistically disappear from the FDA's tracking system.
Other factors contribute to the under-reporting of deaths involving siderails. Some deaths may be uncounted because of incomplete deathcertificates. In some cases, the exact cause of death can remain a mystery.
An example may be a death earlier this year of 84-year-old Dolores Dallavia, who was found wedged between the mattress and siderail of her bed at Lakeshore Lutheran Home in Duluth.
Police are still investigating her death and her family declined an interview for this series. Although an autopsy was performed, as of last Friday, no cause of death had been assigned to the death certificate.
Lakeshore Lutheran Home administrator John Korzendorfer said state investigators and his own staff could not tell whether the woman had died and then slid into the siderails or whether she had become trapped and then died.
Safe in bed no more
The U.S. nursing home industry has gone through a sea change in the past decade in how it cares for older people.
Fifteen years ago, more than half of nursing home residents were either sedated or tied down so as not to pose a danger to themselves or to others.
That has changed dramatically -- due to pressure from families and consumer groups on doctors and nursing homes to stop drugging and restraining elderly people.
Until recently, the same scrutiny has not been applied to bed siderails.
Despite numerous studies that have documented the threat posed by bed siderails, the FDA has taken the position that the problems with bed siderails stem as much from their use as their design.
``The basic problem looks like it's occurring with vulnerable patients interacting with medical devices,' said Kessler of the FDA. ``Hospital beds are just one problem with patients who are frail or demented. Just trying to fix siderail distances will only fix a small part of the problem.
The idea that beds could be dangerous for frail or confused elderly people was also missed by the Minnesota state agency charged with inspecting nursing homes and investigating unusual deaths. The Minnesota Department of Health took no consistent action on siderail-related fatalities even after it became aware of several such deaths in 1995 and 1996.
It wasn't until April of this year that Minnesota health officials took a hard look at beds and siderails in nursing homes.
In July, the state health department sent a bulletin to the state's 440 nursing homes about siderail use. The eight-page bulletin devoted one paragraph to the possible dangers in siderail design, saying it was up to nursing homes to evaluate whether beds and siderails could be deadly.
``We missed the boat,' said H. Michael Tripple, a lawyer and assistant director of the Minnesota Department of Health's Division of Facility and Provider Compliance. ``Our awareness should have been there. The industry's awareness should have been there. Potentially, we would have been able to prevent some deaths.'
Solutions are available
There are three ways to prevent elderly people from dying in bed siderails -- better nursing practices, better beds and better siderails.
``What you want in nursing homes is to move toward a more livable environment,' said Robert Kane, a leading nursing home researcher and professor at the University of Minnesota. ``The first thing is that bedrails should only be used after great consideration. We don't want to make them the norm of care. When (you) do (use them), you want them to be designed as well as possible.'
Kane and others are challenging the long-held belief that siderails are safety devices -- a topic of intense debate within the nursing home industry. A growing number of studies show that more injuries in nursing homes happen when siderails are raised.
Simply helping older residents get to the bathroom more often at night is a big part of the solution, conclude nurses and other caregivers who have studied this issue. Many siderail problems happen when people are trying to get out of bed, usually to use the bathroom.
``This is really about giving people care based on their needs,' said Dr. Colleen Cooper with the Minnesota Department of Health.
Many bed manufacturers are coming out with beds that can be lowered nearly to the floor, which could be easier for residents to use. If someone fell from a low bed, that person would be unlikely to suffer serious injury.
Simmons Healthcare, a Georgia bed manufacturer, recently came out with beds that can be raised or lowered nearly to the floor. The company has models that can be operated by hand or with electrical mechanisms, said Wayne Coleman, Simmons executive vice president.
Bed maker Hill-Rom Inc. has redesigned its siderails as well as developing low beds, said Christopher Feeney, spokesman for the firm's parent company, Hillenbrand Industries, in Batesville, Ind.
``We have designed ... gap fillers that facilities can use to fill the gaps between (mattress and siderail),' Feeney said. ``We have redesigned our rails to make them smaller to reduce that gap. (And) we have a new product coming out that will allow the bed to be lowered to 10 inches off the floor.'
Miles, a geriatrician and University of Minnesota bioethicist, says manufacturers and health-care facilities need to work to solve the problems with bed design. His suggestions:
*Manufacturers need to design beds and mattresses that fit snugly together.
*Manufacturers need to label siderails for use with specific beds.
*Manufacturers need to redesign siderail spaces so that a 90-pound patient cannot slip through them.
*Health-care facilities should buy safer beds when they replace old equipment.
*Health-care facilities should follow manufacturers' instructions.
Many of these solutions are expensive. New beds that lower to the floor can cost as much as $1,000 apiece. But many solutions are much less costly.
Some cost very little, such as foam bumpers that cover the gaps in siderails. These devices cost as little as $15 a bed.
Even less costly are techniques being used by some Minnesota nursing homes as they re-evaluate their siderail use, said Linda Sutherland, director of the Minnesota Division of Facility and Provider Compliance, the state agency that inspects nursing homes.
Some nursing homes, such as Lakeshore Lutheran Home in Duluth, are making their own mesh covers for siderails, she said.
Others facilities ``have taken blankets and rolled a sheet around them and placed them in the gap between the mattress and siderail,' Sutherland said. ``That would be fine."