Anyone who has worked in hospital quality improvement for a substantial time period has probably seen or heard of at least one incident of bed rail entrapment with injury or a near-miss. Also, bed rails probably had some degree of “guilt by association” dating back to the late 1980’s and early 1990’s debates about use of “restraints”. (It should be clear in further discussion that we are not talking about bed rails as restraint devices. In those rare instances where your facility may be using them as restraints, make sure you include them as part of your restraint policy and procedures.) In 1995 the FDA issued a Safety Alert: Entrapment Hazards with Hospital Bed Side Rails about 102 bed rail entrapment incidents over a 5 year period. The report identified certain risk characteristics of patients involved and circumstances related to the beds and rails. The Veterans’ Administration issued a patient safety alert about bed rail entrapment in 2001. In 2002 Joint Commission issued a Sentinel Event Alert about 7 deaths or injuries related to bed rails over a 7-year period. They included many root causes and risk reduction strategies identified by reporting facilities. So many of us have had largely negative opinions of use of bed rails. But evidence-based medicine adds a dose of reality that makes us reconsider overly negative or overly positive opinions and arrive at rational approaches to the issue of when to use bed rails and when not to use them.
In fact, the discussion about use of bed rails must occur in a much bigger context, that is a discussion about why, how and how often hospitalized patients fall from bed and sustain injury. The purpose of bed rails is to reduce the risk of patients inadvertently slipping, sliding, falling or rolling out of bed. Certain characteristics of patients increase the likelihood that they might fall out of bed, including presence of dementia or delirium, visual or multiple sensory impairment, impaired balance, impaired mobility, or side effects from multiple medications. Bed rails do also serve some additional purposes, such as helping in turning or repositioning in bed, providing some support getting into and out of bed, and perhaps providing easy access to bed contols, call buttons, and personal care items (though there are alternatives for all of these).
Several organizations have actually now done systematic reviews on both the risks and the benefits of use of bed rails in hospitalized patients. However, the approaches on the two sides of the Atlantic appear to be somewhat different, though important lessons can be learned from both approaches.
The Hospital Bed Safety Workgroup in the United States had representatives from Joint Commission, the FDA, the National Patient Safety Foundation, ECRI, multiple clinical organizations, consumer advocacy groups, legal organizations, manufacturers, and others. They published their report in 2003 Clinical Guidance For the Assessment and Implementation of Bed Rails In Hospitals, Long Term Care Facilities, and Home Care Settings. An FDA 2007 update states “Between 1985 and 2005, FDA received 691 incidents of patients caught, trapped, entangled, or strangled in beds. The report included 413 deaths, 120 nonfatal injuries, and 158 cases where staff needed to intervene to prevent injuries. Most patients were frail, elderly or confused.”
Around the same time, the National Patient Safety Agency of the National Health Service in the UK was doing its own review and published a safer practice notice on “Using bedrails safely and effectively” in February 2007 and a companion literature review Bedrails – Reviewing the Evidence (Systematic Literature Review). Their review of incident reports showed that 44,000 hospitalized patients in the UK (1 in 200 inpatients, and about a fourth of all hospital falls) fell out of bed during a one-year period, including 90 patients who suffered fractured femurs, and 11 fatalities. They found that falls without bed rails were more frequent and more likely to be associated with injury, though there was no significant difference in moderate or severe injuries between those with and without bed rails. They also analyzed the hazards of bed rails and found 1250 patients injure themselves on bed rails each year, usually minor scrapes and bruises. They found reports of death due to bed rail entrapment to be rare (3 deaths in a six-year period in acute hospitals but a total of 21 bed rail entrapment deaths for all sites of care). Their work also showed that patients, in general, had a less negative view of bed rails than did healthcare workers. They also found that initiatives to reduce bed rail use too much actually sometimes led to an increase in falls. The evidence study is clearly worth reading. However, its primary value is that it points out the dearth of studies conducted in a scientifically designed manner and most studies on reduction of bed rail use did not stratify patients by risk. Much of what we currently know about bed rail use – both risks and benefits – remains largely anecdotal.
The statistics do make one thing very clear: the potential risks and benefits of using bedrails must be weighed individually in each case. It is clear that not everybody needs bed rails. In fact, most hospitalized patients do not need bed rails. There are several key questions to be asked:
· How likely is it that the patient will fall out of bed?
· How likely is it that he/she would injure himself/herself if they fell out of bed?
· Could the patient injure himself/herself on the bed rails?
· How likely is the patient to try to climb over the bed rails or to try to squeeze through them?
· Does the patient have characteristics that increase the likelihood of bed rail injury?
Ironically, many of the risk factors for falls are also risk factors for bed rail entrapment.
The Hospital Bed Safety Workgroup report notes numerous alternatives to bed rails:
· Use beds that can be raised or lowered closer to the floor
· Keep the bed in the lowest position with wheels locked
· Place mats next to the bed (but be careful they do not increase risk of a fall)
· Make use of other aids to mobility or transfer
· Monitor the patient frequently
· Anticipate the reasons a patient may want to get out of bed and alleviate those needs (eg. toileting, hunger, pain relief, etc.)
Frequent reassessment of both the risk of falling and the need for use of bed rails is needed. We’ve spoken in numerous Tip of the Week columns about the fact that a fall risk assessment is often done on admission and not repeated often enough during a hospitalization. The same applies to bed rail risk assessment.
A substantial number of patients who died from bed rail entrapment had a history of being found in a similar position previously (near-misses) so such should be used as a warning of the highest degree that the patient is high risk for entrapment.
The adequacy of bed rails and associated equipment must also be assessed, with particular attention to the size of “gaps” and use of nonstandard equipment. The FDA issued a guidance in 2006 “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment”. This contains many of the technical aspects of what facilities need to look for in their beds and other equipment in assessing the risk for bed rail entrapment. It talks about many of the mechanisms of entrapment and dimensional issues involved.
One issue is that the risk of entrapment involves more than just the bed rails themselves. It obviously involves a complex interaction between patient risk factors, the environment, the bed rails, and other parts of the bed. A substantial number of the deaths occur when the patient’s head becomes entrapped between the side of the mattress and the bed rail. This especially seems to be a problem with some of the pressure-relieving mattresses. Also, a key problem is that mattresses often wear out before beds or bed rails do. New mattresses purchased may not be appropriate for use with the bed rails. A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment also published by the Hospital Bed Safety Workgroup, gives excellent advice to facilities for conducting inventory of current hospital beds, assessing risk, guiding purchases, etc. There are also patients whose size or weight are inappropriate (too small) for bed size.
Good documentation in the medical record about the decision making process regarding use or non-use of bed rails is important. Where possible, this should be done in an interdisciplinary setting and seek input from all clinical services involved plus input from the patient and/or family. The record should also include documentation of monitoring of bed rail use and of the periodic reassessment of the need for bed rails.
Most importantly, the patient and family need to be brought into the loop on discussions about bed rail use. The potential benefits and risks need to be explained to them just as one would in performing informed consent for a surgical procedure.
And lastly, like any good patient safety or quality improvement initiative, there should be a process for auditing the use of bed rails, including incident reports related to both bed rail injuries and falls from bed. Bed rail use also is another good topic for a FMEA (Failure Mode and Effects Analysis) exercise.