Deaths and injuries from entrapments in bed rails continue to be a problem, especially for the frail, the cognitively impaired, or incapacitated elderly. This is an issue not only for home users of bed rails, but also for long-term care facilities and Centers for Medicare & Medicaid Services. A pending CMS rule, titled “Medicare and Medicaid Programs; Reform of Requirements for Long-Term Care Facilities” directly addresses bed rail use.
The relevant paragraphs of the proposed rule occur as revisions to 483.25 to be re-titled Quality of Care and Quality of Life, and 483.90 – Physical Environment. Within the 483.25 section, 483.25(d)(2) newly proposes to establish specific requirements when a facility uses bed rails on a resident’s bed.
The proposed 483.25(d)(2) reads:
Bed rails. The facility must ensure correct installation, use and maintenance of bed rails, including but not limited to the following elements. (i) Attempt to use alternatives prior to installing a side or bed rail. (ii) Assess resident for risk of entrapment from bed rails prior to installation. (iii) Review the risks and benefits of bed rails with the resident or resident representative and obtain informed consent prior to installation (iv) Ensure that the resident’s size and weight are appropriate for the bed’s dimensions. (v) Follow the manufacturers’ recommendations and specifications for installing and maintaining bed rails.
These ideas are basically sound but their implementation may be too open ended and result in perfunctory rather than meaningful compliance.
Item (i) may mean an actual attempt to use alternatives to bed rails, or it may mean considering such an attempt. In either case what will be an acceptable basis for deciding that the attempt was a failure and that bed rails are therefore necessary? Attempting not to use a bedrail should not be imbedded in a section that begins with installation, use and maintenance and which is otherwise focused on using bed rails rather than not using them. The action of attempting to use alternatives should be separate from (d)(2).
Additional suggestions of what to consider include lowered beds and cushioning or an additional mattress placed on a floor by the bedside if there is a fear of a person falling out of bed. While doing the above may be more inconvenient for the personnel who need to help those people regardless of whether or not a rail is next to their bed, it will eliminate death by bed rail.
The assessment of (ii) lacks any methodology. On what basis will personnel do this assessment? How will they learn how to do it? How will the assessment be documented? A doctor’s prescription cannot be relied on this regard since the doctor may not be familiar with the actual equipment in use. Prescriptions that read “hospital bed”, or even “hospital bed with rails” generally do not represent an adequate assessment as is demonstrated by deaths that have occurred after such prescriptions have been followed.
For item (iii), the presentation of risks and benefits is likely to be biased toward the decision already made–that bed rails should be used. “Safety” will likely be emphasized and risks minimized. Perhaps a standardized consent form is needed, preferably one that includes the FDA’s illustration of what entrapments actually look like.
Consent should never be used to overcome bad assessment, bad design or bad selection. Consent forms also should not be used only to transfer the risk to the patient instead of it being the responsibility of the facilities and manufacturers to properly mitigate risk. In this regard people signing consent forms may not actually understand the risks or that they are absolving the facility of responsibility
Item (iv) talks about ensuring that the resident’s size and weight are appropriate for the bed’s dimensions. But, again, how is this going to be done, and by whom? And how did they become qualified to do so? Here it can be noted that bed rails generally do not have any listed size restrictions, even though such restrictions may have been used by the manufacturer during their design process. This requirement misplaces the onus on the end user to determine what the design specifications of the product are. Instead design specifications should be explicitly provided by the manufacturer.
More generally, effective assessments such as those indicated require more than just an eye-ball look over. Entrapment is a mechanical issue involving components, openings, gaps, and mattress size and compliance. A bed system and resident generally cannot just be looked at as a basis for making a proper assessment, although in some cases equipment can be ruled out. If the latter is the case, then that equipment probably needs to be discarded.
With respect to item (v) the installer might look at the manufacturer’s instructions for use, but these documents are likely to become separated from the product. If rental agencies are involved the literature may never reach the facility at all. In addition the various key components of a bed system (frame, rail and mattress) may come from different manufacturers, and these components may be reconfigured over time such that the initial installation becomes moot. Bed rails are also manipulated during the day by caregivers on multiple shifts, particularly as bed sheets are changed. Will they have access to the written instructions? If so, will they ever look at them?
The proposed section 483.90(c)(3) states:
Conduct regular inspection of all bed frames, mattresses, and bed rails, if any, as part of a regular maintenance program to identify areas of possible entrapment. When bed rails and mattresses are used and purchased separately from the bed frame, the facility must ensure that the bed rails, mattress, and bed frame are compatible.
As above, this provision lacks any specification of methodology or training with respect to such inspections or compatibility determinations. Furthermore a proper assessment of compatibility requires a fixed protocol and measurement equipment rather than just a visual assessment. Manufacturers generally do not provide compatibility information for the use of their products with parts from other manufacturers, unless it is to say not to do so. Even a combination of components from the same manufacturer may not be compatible if they are mixed and matched across product lines or involve accessories, eg e.g., an added air mattress. If rented components are used then who the various manufacturers are may not be apparent since not all of the parts may have permanent labeling of manufacturer or model number. Parts without manufacturer labels also preclude finding out if they are still on the market or if they have been replaced by safer designs. Unlabeled products also prevent effective reporting of entrapments and thereby the prevention of future entrapments. The use of unlabeled equipment should not be permitted whether it is facility owned or rented.
The language of (c)(3) also needs to be extended to more thorough purchasing and renting processes. Facilities should be required to obtain from manufacturers or rental agencies specific information on compliance with FDA or other design guidelines, Facilities should also ask manufacturers and rental agencies for information on other reported deaths or injuries, and for check the manufacturers’ response against the FDA MAUDE database when applicable.
Resident observation
It must also be remembered that constant surveillance of bed rail users, while desirable, is not likely to be the reality at any facility. There are reports where caregivers left a room in which there is a patient who has a bed rail, and returning to the person in less than 5 minutes to find them dead, asphyxiated in their bed rail. It is important to understand that it doesn’t necessarily matter how often or how carefully one monitors a bed rail, the potential for entrapment or for a patient to try to climb over the rail is ever-present. Monitoring systems also often fail at getting help to a patient in a timely manner, i.e., between entrapment and death. Surveillance and monitoring cannot make up for dangerous beds or bed components.
In addition to entrapment, enhanced falls occur as residents attempt to climb over rails, and thereby fall from a greater height. Such attempts are not addressed by most bed rail designs. Such falls are another reason to minimize bed rail use.
Summary
A resident’s environment needs to be as free of accident hazards as possible. It is important to point out in this regard that bed rails are a demonstrated hazard and their efficacy has been little studied. Improving how the need for bed rail use is determined, and which equipment is appropriate, is potentially valuable but rules without methodology will not reach the goal, especially when dangerous bed rails continue to be available and used. In this regard the proposed rules may only become another layer of check lists without any actual impact on resident safety.
William A. Hyman is a professor in the Department of Biomedical Engineering at Texas A & M University in College Station, TX. Gloria Black is a bed rail activist at Consumer Federation of America (CFA) and the National Consumer Voice for Quality Long-Term Care (Consumer Voice).
