Among the strategies facilities can use to protect residents from harm are identifying persons at risk, implementing interventions, and testing and monitoring beds.

A

lthough side rails have been used in healthcare beds for many years, these seemingly simple devices are not without risk. Reports received by the Food and Drug Administration (FDA) demonstrate that many elderly persons are at risk for becoming entrapped.¹ And for a society in which safety is a prime concern, mitigation of risk is of utmost importance.
       The initial purpose of side rails was to prevent falls. During the 1970s and 1980s, nursing schools taught students to raise the bed rails for patients thought to be at risk for falls after administering pain-relieving medications, hypnotics, and sedatives; for their post-operative patients; and for patients who suffered previous falls. In some facilities, all patients were placed on fall precautions in order to prevent falls and subsequent injuries. One component of fall precautions was to raise the beds’ side rails. This practice continued until research demonstrated that side rails were not preventing falls and, in fact, may have been contributing to more serious injuries resulting from an individual falling out of a bed.² One study, however, did show that hospital bed rails can aid in the prevention of falls.³
       In 1995, the FDA issued a safety alert concerning entrapment related to side rails. In the five years prior, the agency received 68 reports of deaths related to side rail entrapment. The alert contained measures to reduce risk and information on reporting these and similar incidents per the Safe Medical Devices Act (SMDA) of 1990.¹ The FDA determined that certain areas of the bed were potential sites at which entrapment could occur in a patient assessed to be at risk. These areas or zones are in the spaces between the rails themselves, under the rails,

Figure 1

between the rails, between the rails and the mattress, and between the mattress and the head or footboard (see Figure 1).¹ Entrapments involving the head, neck, or thorax are most likely to result in fatalities, and limb entrapments may result in injuries like fractures and abrasions.^1,4
       Between 1985 and 2006, the FDA received 691 reports of healthcare bed entrapment. Of those, 413 related to deaths, 120 to injuries, and 158 to near misses.⁴ Reported entrapments occurred in all healthcare settings, with the most reported in long-term care.⁴ Analysis of the reported incidents demonstrated that those found to be most at risk for entrapment

Figure 2

were the frail elderly and those having altered mental status, impaired muscle coordination, restlessness, or any combination of these factors (see Figure 2 for the relationship of associated factors).⁵ Not only are many individuals with these characteristics residing in nursing homes, but these persons likely spend more time in bed.

Solutions

       In an effort to minimize this potentially serious threat to some of the most helpless patients receiving medical care, the FDA formed the Hospital Bed Safety Workgroup (HBSW) in 1999 to study this problem and make recommendations to reduce entrapment risk. In 2003, the group (comprised of hospital bed industry members, government agencies, other regulatory agencies, and advocacy groups) published a clinical guideline applicable

Table 1

to all healthcare settings. The guideline contains recommendations to assist those caring for patients to minimize the risk of entrapment (see Table 1).⁵ Included in the clinical guideline are the risks and benefits of bed rail use as well as policy and procedural suggestions.
       Utilizing the rail as a hand hold for entering or exiting the bed, using it to pull oneself up in the bed, promoting a feeling of safety and security, and reminding an individual to call for assistance before exiting the bed are some examples of the benefits of side rails. Entrapment injuries (eg, abrasions, fractures, and smothering) are possible risks of side rail use, however, and for some individuals, more serious injuries may result from falling over a rail from a higher height.⁵
       Policy and procedural considerations emphasize the need to assess each patient or resident as an individual. Important aspects of this assessment are mobility, cognitive status, family and social history, usual sleep patterns, toileting needs, nutritional and hydration needs, and review of medications (eg, hypnotics and diuretics). Care planning should include not only the members of the healthcare team but the patient and family as well. Care planning is best accomplished by an interdisciplinary team.⁵
       Interventions to minimize entrapment risk that may be part of the care plan include the use of adjustable low-height beds, mats on the floor next to the beds, call systems, position alarms, and lifting-aid devices. Healthcare team interventions include individualized toileting schedules, adjustment of medications (if possible), mental status evaluation, and verbal reminders to call for help to exit the bed. Care planning must also consider the risk/benefit analysis of any and all interventions.⁵
       Education of patients and their family members is also important. Nursing and other staff should also be educated about entrapment risks. Education is advocated by both the HBSW and The Joint Commission (formerly the Joint Commission on Accreditation of Healthcare Organizations [JCAHO]).^5,6
       In its “Sentinel Event Alert: Bed Rail-related Entrapment Deaths” document of 2002, the Joint Commission stated it “require[s] that organizations have a patient safety program that encompasses performance improvement, environmental safety, and risk management; however, the standards do not prescribe how these activities should be structured.”⁶ In addition to the previously recommended education, The Joint Commission urges assessment of patients for risk of entrapment, more frequent surveillance of those patients determined to be at risk, evaluation of beds, the use of retro-fit kits when necessary, clear side-rail pads, and anti-skid mats.
       It has been determined that the reporting of near misses is important, following the 1999 report of the Institute of Medicine (IOM) on the number of deaths related to medical errors. The reporting of near misses may help to reduce medical errors and injuries by functioning as a means to analyze why an error occurred, encouraging the institution to implement measures to prevent future incidents. The reporting of near misses is also useful as an educational tool.^7,8
       In its 2005 draft of requirements for healthcare beds, the International Technical Commission (IEC) issued recommendations for specific gap-size limitations to reduce the risk of entrapment. This document was a draft and is currently undergoing revision. The gap measurements were based on anthropometrical measurements, including data from height, weight, cranial measurements, and osteometry. The IEC document is concerned with the electrically and manually operated healthcare and does not consider the mattress in its draft of requirements.⁹ In its 2006 document, “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment—Guidance for Industry and FDA Staff,” the FDA considered the mattress in its measurements and used anthropometrical data and data from reported entrapments (eg, a dimension of 4 3/4 inches for the female 5th percentile measurement of head breadth is the recommended limit for Zone 2.)⁴ Included were the dimension of 2 3/8 inches, representing the neck diameter of 1st percentile female with compressed neck tissue. In order to prevent wedging, an angle

Table 2

of greater than 60 degrees is also included to prevent a neck entrapment in any V-shaped openings. These recommended dimensions (see Table 2) are the same as those recommended by the HBSW and the IEC. To prevent entrapment of a chest in the space between split side rails, the FDA document recommends the dimension of 12 1/2 inches. This measurement corresponds to the chest depth of the 95th percentile male. The zones or locations where entrapment may potentially occur are:
• Zone 1: within the rail
• Zone 2: under the rail, between the rail supports, or next to a single rail support
• Zone 3: between the rail and the mattress
• Zone 4: under the rail, at the ends to the rail
• Zone 5: between split bed rails
• Zone 6: between the end of the rail and the side edge of the head or footboard
• Zone 7: between the head or foot board and the mattress end.⁴
       Specific recommendations for the dimensional limits are given only for zones 1–4. Those zones are the locations of most of the reported entrapment events. The recommendation for Zone 1 is intended to prevent a head entrapment in the spaces within the rail. That dimension of that opening should be less than 4 3/4 inches. The recommendation for Zone 2 is intended to prevent an entrapment in the space “under the rail between a mattress compressed by the weight of a patient’s head and the bottom edge of the rail at a location between the rail supports or next to a single rail support. If there is a single rail support, entrapment in Zone 2 can occur anywhere along the bottom length of the rail beyond the support up to the end of the rail.” The recommended dimension for this zone is less than 4 3/4 inches.⁴
       For Zone 3, the space between the rail and the mattress, the recommended dimension is less than 4 3/4 inches. The intention is to minimize the risk of a patient compressing the mattress edge and becoming entrapped in the gap between the rail and the mattress and possibly smothering. It is important that the rails are secure to ensure safety in this zone.⁴
       The dimension recommended for Zone 4, the space under the rail at the ends to the rail, is less than 2 3/4 inches. This space occurs when the patient compresses the mattress, increasing the gap and possibly leading to an entrapment under the end of the rail. This gap size varies depending on the position of the bed (ie, it may be one size with the bed deck flat and a different size when the bed is articulated or the head and foot section raised). Again, it is important for rails to be secure.⁴
       Dimensional limits were not recommended for Zones 5, 6, and 7 in the FDA guidance document. The IEC does have dimensional recommendations for Zones 1, 2, 4, and 6 in its document, which is currently undergoing revision. Their revised document is expected to have recommended dimensions for Zones 1–6.⁴
       For f

Figure 3

acilities to test their bed systems, there is a test tool kit available from National Safety Technologies (see Figure 3). The kit includes the tool, an educational video, instructions on the use of the tool, and pages for documentation of the tests (visit www.nst-usa.com for more information).⁴
       In its aforementioned guidance documents, the FDA and HBSW afforded members of the healthcare team in all settings valuable information and tools to protect the vulnerable elderly population from harm.While it is important to note that the FDA document is referred to as a guidance document and that it is “nonbinding”8 at this point, the Centers for Medicare & Medicaid Services does currently assess long-term care facilities for use of side rails under the surveyor’s guidance Federal Tags 221 and 222 (F221 and F222) as related to restraint use, falls, and entrapment.¹⁰

Conclusion

       It is vital to protect these susceptible persons in all healthcare settings from possible harm. Assessment and identification of those at risk for entrapment, implementation of interventions as recommended by the HBSW in the clinical guideline following an individualized plan of care, and following the FDA’s recommendations for bed testing and monitoring can help to minimize risk—as can the healthcare bed manufacturing industry by complying with the guidance document’s specifications.