Bed-rail entrapments still a serious problem
Another hospital bed entrapment concern: 'power down' versus 'gravity down'
The U.S. Food and Drug Administration has recognized and reported on the problem of lethal entrapments for over 10 years, but it has not ordered recalls. Some manufacturers have designed safer rails yet not replaced those already in use. And despite the publicity efforts of the FDA, The Joint Commission published articles and others, there continues to be a lack of practical understanding of the nature of this hazard and how to recognize a dangerous bed.
The time to end lethal bed-rail entrapments is now, and the way to do it is to remove from the inventory those bed-rail systems that are unreasonably dangerous, and to insist that suppliers provide beds that at least meet current guidelines.
It is now 13 years since the FDA's Safety Alert on the dangers of entrapment in bed rails, and other parts of hospital and nursing home beds (1). This alert was directed to Home Healthcare Agencies, Hospices, and Nursing Homes, among others. It was based, in part, on already published work and reports to the FDA of deaths and injuries associated with beds and bed rails, the latter going back to publicly available data since 1985. The FDA alert triggered a number of related reports and announcements in the clinical literature (2- 4).
The entrapment issues stimulated the creation of the Hospital Bed Safety Workgroup (HBSW) (5) in 1999. The work group is a partnership among FDA, the medical bed industry, national healthcare organizations, patient advocacy groups and other federal agencies. This group labored for many years to reconcile the diverse interests of its members, and to balance safety and economic concerns. The HBSW ultimately produced a brochure, which currently has a 2006 update date, along with guidance documents and a gap measurement methodology. Earlier drafts of the guidelines also were publicly available, but are no longer posted at the FDA/HBSW Web site. The guidance is not applicable to all beds. For example, air-fluidized beds, bariatric beds, pediatric beds, infant cribs, and pressure-reduction products such as air mattresses are fully or partially excluded. Air mattresses that replace the regular mattress may present particular risk for under the side rail entrapment because of the high compressibility of the air mattress at the edge (6). It is notable that air mattresses in particular are excluded—not because of any lack of risk, but because of “technically difficulties with measuring certain dimensional gaps.”
Articles and other material on bed and bed rail entrapment hazards have continued to appear in announcements from the FDA (7), The Joint Commission (8), the Veteran's Administration (9), on National Public Radio (10), and in the pages of Nursing Homes (11). The latter article addresses the March 10, 2006, FDA guidance (12).
Regrettably, none of the FDA's efforts have resulted in recalls or other manufacturer formal actions to remove dangerous bed-rail systems from use. In fact, the guidance notes that the “FDA does not intend to take enforcement actions for failure to submit reports of corrections and removals under 21 CFR Part 806 for actions taken in response to this guidance that correct or improve hospital beds currently in use or held as inventory” (12). Thus, the manufacturers achieved protection from the “recall” label, if they took any action at all. Individual nursing homes or equipment dealers may have removed from inventory certain bed systems, but their disposition is unknown. At least some design improvements for new equipment have become available. While the latter may increase the safety of newly purchased beds, it does not protect either patients or providers from the use of older equipment. In fact, the open availability of better products, along with the extensive literature on the hazard, most likely increases the liability exposure of the nursing home, particularly with respect to the possible assertion that they didn't know about the risk.
Although the effort to inform the user community about bed-rail entrapment hazards has been ongoing, there continue to be deaths in nursing homes resulting from such entrapments. Some individual nursing homes have had more than one such death, and some corporate chains have had deaths in more than one facility. In some cases, corporate level expertise has generated warnings and or guidance documents to their individual facilities, but whether there has been decisive or ongoing vigilance with respect to these issues is not clear.
What is the problem?
The basic bed-rail entrapment problem is that the design of the bed frame, the bed rail and the mattress may create gaps into which body parts can become trapped. These components together are called the bed system. When the body part is the neck or chest, this can lead to death. Seven particular entrapment zones have been clearly identified and graphically illustrated. These are:
Zone 1: Within (between) the bars of the rails
Zone 2: Under the bottom rail, between the rail and the mattress or bed frame
Zone 3: In the gap between the rails and the mattress
Zone 4: Under the rail and between the rail and the mattress at the outside edge of the rail
Zone 5: Between split rails
Zone 6: Between the end of the rail and the head or foot board
Zone 7: Between the end of the mattress and the head or foot board
The FDA guidance, which is voluntary, only contains test protocols for Zones 1-4. Thus, a bed that asserts it is compliant with the guidance may not adequately address all of the zones. It should also be noted that the situations illustrated are not the only relevant risks. For example, in Zone 2 the illustration shows the head having entered the gap. Alternatively, the body can slide through this gap while the head might not, leading to strangulation aided by body weight. Such a situation is shown in the Zone 4 and Zone 5 graphics, but those graphics do not in turn show headfirst entry. Also, Zones 2 and 3 are highly interactive. The space between the bottom rail and the top of the mattress relevant to Zone 2 is a function of both the horizontal distance between the inner face of the bed rails and the edge of the mattress and the vertical space between the bottom of the lowest rail and the top of the mattress. The resulting oblique distance can be substantially increased as body weight compresses the edge of the mattress.
The “gap” in Zone 3 is a function of the horizontal distance between the edge of the mattress and the inside face of the bed rail, but the risk is also a function of where the bottom rails are as well as the compressibility of the mattress. In addition, whether the mattress is centered or not affects the Zone 2 and 3 gaps and assessment should be made with the mattress pushed all the way to one side, even if no-slip pads or physical mattress retention systems are supposed to be used. In many designs, this horizontal gap seems to have been intentionally increased by the bed or bed rail manufacturer by making the structure that holds the bed rail stand out from the bed frame that supports the mattress. This may be to facilitate raising and lowering the bed rail, or being able to change the bedding, without interference from contact between the mattress and the rails.
However, this convenience feature increases the risk of entrapment and is therefore a poor trade-off. Some newer designs move the side rails closer to the mattress, and add one or more bars to the bottom of the side rails in order to reduce or eliminate the vertical component of the Zone 2 gap. It must also be noted that articulating the bed can significantly increase the Zone 2 gap in a full rail. In turn, readjusting the rail, if there are adjustment points between fully up and fully down, can reduce this gap increase, but this requires specific knowledge and consistent action by staff.
The challenge of bed assessment is increased by the mix of products that may become in use even at a single facility. For example, any two or all three of the bed, bed rails, and mattress may come from different manufactures. Thus, a bed system that was reasonably safe today may become relatively unsafe if any component is changed tomorrow. The mismatch is facilitated by many components being more-or-less mechanically interchangeable, even though they may be functionally different. This mismatch can be a particular challenge when rental equipment is used since the rental supplier may have a variety of bed components in its inventory such that one day's delivery is relatively safe while the next bed delivered is relatively unsafe.
In addition, not all patients are of equal risk. In particular, small, lightweight patients are generally at the greatest risk given that their small physical dimensions may enhance their ability to fit into a gap, in whole or in part. Of course, such relatively small people are a common element in many nursing home settings. Another patient consideration is mobility, agitation and temporary or chronic reduced mental capacity. In this regard it must be understood that a major critical use situation of the bed rail will be when the bed occupant moves or rolls into contact with the rails. Often, this occupant will not be in full use of normal physical or mental faculties. Pretending that a bed rail is only to “remind” the occupant that they have come to the edge, or that it is only an aid to turning or bed egress (half-rails), is a fantasy that does not address actually use and risk. This fantasy is partially driven by the need to reduce restraints, as well as by manufacturer's liability “risk management” by disclaimer.
What are the real solutions?
When bed rails are indicated and specifically ordered, the ideal solution is to not have any beds or bed systems that present unreasonable risks of entrapment. This is the only solution that eliminates the problem, and elimination is always the first choice in hazard reduction. In addition, elimination of hazardous bed systems by manufacturers addresses the problem where the solution can be most effectively implemented, rather than relying on the far more numerous users to address the problem. This has been called solving the problem at the blunt end, rather than at the sharp end where the hazard actually manifests itself. At the blunt end the manufacturer also has more technical expertise and is not under short time constraints.
Addressing elimination at the local or facility corporate level requires an assessment of current bed systems and combinations, and a replacement strategy using manufacturer certified compliant beds. To aid in this process, the manufacturer of a single sourced existing bed system should in principle be a good source of information as to whether that bed system is compliant if properly maintained. An answer that is not meaningful is a bad sign. A rental supplier should be similarly asked what their own assessment of their equipment has revealed. If either the bed manufacturer or rental supplier hasn't done an assessment, doesn't understand the question, or asserts that the guidance is only a guidance and/or that it doesn't apply to older beds, it may be time to find new sources.
When replacing or adding beds, it is not logical to buy a new bed system and then take on the primary responsibility of measuring it for compliance. Contracts with suppliers must specify that only bed systems that are compliant may be delivered to the facility or its patients, and actual compliance with this contract provision must be assured. However, even here it must be remembered that the FDA guidance does not address all hazards, e.g. most measurements are made with the bed flat or with an assumed direction of into the entrapment Zone. Thus, it is equally appropriate to ask manufacturers what they themselves have done to address entrapment risks, aside from or in addition to the FDA guidance.
In addition, active policies must be in place with respect to maintaining system integrity with respect to replacement parts including mattresses. Similarly, separate or add-on products such as air mattresses must be certified by their manufacturer, or physically tested within the facility, to assure that their use does not increases the entrapment risk. Such testing must use specific and meaningful criteria. Associated product demonstrations must consist of a full system of mattress, bed and bed rails. Demonstrating an air mattress on a cafeteria table will not adequately address entrapment risks. If the product does increase the entrapment risk, but is desirable none-the-less, explicit and realistic measures to mitigate the risk must be identified and consistently implemented. It is not appropriate to simply “accept” the risk without mitigation.
A less-than-ideal solution is to identify bed, bed rail, mattress combinations that are of greater risk than some other combinations, and to create a system that assures that the undesirable combinations are never used. As above, a similar requirement must be placed on rental suppliers. Another less-than-ideal approach is to identify bed, bed rail, mattress combinations that present increased risk to certain segments of the patient population (e.g. patient's below a certain weight), and to have a functional and realistic plan to assure that such patients are not put in high risk beds. For a bed system from a single manufacturer, if there is a population for which the product is not suitable, that population should be identified by the manufacturer as a contraindication. On the other hand, broad warnings that seek in effect to shift the burden to the end user should be recognized and the product avoided.
The challenge in implementing either a product- intensive or patient-intensive plan is that each requires ongoing vigilance by trained and knowledgeable people. The associated challenge is training relevant personnel so that they can and will make informed judgments about the suitability of a bed system for a particular patient or type of patient. Such training must include specific and measurable criteria. For example, an instruction to “make sure the gap is not too big” is basically meaningless since it does not adequately address whether the gap in question is viewed from the side or above or at an angle, whether it is actually measured or just eyeballed, and what in fact makes a gap “too big.” Similarly, entrapment risk warning labels on inherently dangerous products that do not provide any clear guidance as to how to assess the bed or the patient cannot be effective, unless used as a guide to not purchase such a product in the first place.
Another facility-based work-around for excessive gaps, besides realistic bed and patient assessment, is attempts to fill such gaps with dedicated or ad hoc products. Such solutions must be carefully assessed for their actual suitability and effectiveness. They also must be routinely practiced or the situation could end up that a risk was identified and a solution was identified, but the solution was not implemented, thereby leading to death. Furthermore, such work-arounds are inherently an attempt to locally fix a situation that should not exist in the first place.
Explaining the death that occurs
When an entrapment death occurs, there will often be a common set of facts that must be addressed. One is that the death itself demonstrates the hazard, and that the general hazards are “well known,” and have been for well over a decade. The issue may also be compounded by a state level facility investigation and sanctions. This makes a claim of not knowing about the hazard hard to justify for both the facility and equipment suppliers, yet such a defense is often made. In this regard it should be noted that there are few other patient deaths for which graphic illustrations already exist, and even more graphic photographs may be taken.
Second, it may be the case that the hazard is “obvious” to a knowledgeable observer, and can be readily demonstrated. For example, a test device such as that recommended by the FDA may freely fall through an oversize gap, even without pressure on the mattress or simple hand pressure on the mattress may open a clearly dangerous gap. The manufacturer may use this fact to assert that it should then have been obvious to the users at the facility, and that they had provided various warnings. However, in the absence of specific training about the hazard and its meaningful assessment, such obviousness will likely not actually be within the working knowledge of the caregivers.
The current situation
The current situation with respect to bed-rail dangers is that (a) entrapment hazards have been clearly identified, (b) bed systems that embody those hazards continue to exist in nursing home and rental agency inventories, (c) bed system or bed components that do not adequately address these hazards are still on the market, (d) too many nursing homes and equipment suppliers either remain uninformed or do not have an effective action plan to mitigate the risks, and (e) bed users continue to die.
The FDA's action to address this situation has been limited to safety alerts, brochures and guidance documents, and seemingly protecting manufacturers from recalls. In addition, many bed rails receive relatively little regulatory review before being marketed because of the FDA classification of hospital beds. The responsible nursing home should act now to assess its, and its supplier's inventory, and to institute a clear and effective plan to eliminate or actively and effectively manage the entrapment hazard.
While it is true that some bed systems may be safe for some patients yet unsafe for others, the continued presence and deployment of bed rails and beds that are known to be hazardous to at least a common class of patients presents excessive opportunity for these bed rails to be used for inappropriate patients.
A patient dying from strangulation in a bed rail is clearly an event that is intolerable when it occurs because of well-known bad bed rail design, or a bad bed rail/bed/mattress system. The often-associated lack of continuous observation is hardly surprising and is in fact what can be reasonably expected in most care settings.
When entrapment and strangulation occurs with older designs that should have been recalled or replaced, the situation is even more offensive. And when those same bed rails have contributed to prior deaths, and continue to be used, the offensive is magnified. The time to retire dangerous bed rails is now!
William A. Hyman is a professor in the Department of Biomedical Engineering at Texas A & M University in College Station, TX. You can e-mail him at firstname.lastname@example.org or call him at 979-845-5593. For more, go to http://biomed.tamu.edu.
1. FDA Safety Alert, Entrapment Hazards with Hospital Bed Side Rails, dated August 23, 1995, http://www.fda.gov/cdrh/bedrails.html.
2. FDA, FDA Issues Warning about Hospital Bed Side Rails, FDA Consumer, 29, December, 1995.
3. Todd, J., Ruhl, C., & Gross, T., Injury and Death Associated with Hospital Bed Side-Rails: Reports to the U.S. Food and Drug Administration from 1985 to 1995, American Journal of Public Health 87 (10): 1675-1677, 1997.
4. Parker, K., Miles, SH., Deaths caused by bed rails. Journal of the American Geriatrics Society, 45:797-802, 1997.
5. FDA, Hospital Bed Safety Workgroup, http://www.fda.gov/cdrh/beds/.
6. Miles, S., Deaths between bedrails and air pressure mattresses. Journal of the American Geriatrics Society, 50, 1124-1125, 2002.
7. FDA, Hospital Bed Safety Workgroup, dated, Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings, http://www.ute.kendal.org/learning/documents/clinicalguidance_SideRails.pdf, April, 2003.
8. The Joint Commission, Bed rail-related entrapment deaths, dated September 6, 2002, http://www.jointcommission.org/SentinelEvents/SentinelEventAlert/sea_27.htm.
9. Veterans Administration, National Center for Patient Safety, Bed Rail Entrapment, http://www.va.gov/ncps/alerts.html, July 12, 2001.
10. Shapiro, J., Bedrails Can Cause Death in Frail Elderly, National Public Radio, http://www.npr.org/templates/story/story.php?storyId=5519589, June 29, 2006.
11. FDA bed safety guidance: Mitigating risk: Interviews with Larry Kessler and Marc Bruley, Nursing Homes, May, 2006, Available on line at http://www.nursinghomesmagazine.com/ME2/Default.asp.
12. FDA, Hospital Bed Safety Workgroup, Hospital Bed System Dimensional and http://www.fda.gov/cdrh/beds/guidance/1537.html Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff, dated March 10, 2006.