Bed Rail Safety

The Food and Drug Administration (FDA) is the federal agency whose mission it is "to promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continuing safety after they are in use." In May, 1999, the FDA's Center for Devices and Radiological Health convened the Hospital Bed Safety Workgroup (HBSW) in response to statistics relating to deaths resulting from entrapments in hospital bed rails and to examine the issues of entrapment in various components of hospital bed systems. Membership of the group is composed of representatives from nursing, home care, long term care, bed manufacturers, patient safety related groups, and others, including ASHE and JCAHO. The original direction of the group was to potentially regulate bed rails as medical devices. Since that time, the HBSW has been working to develop documents and tools to reduce the potential for entrapment in hospital bed systems.

In this context, "hospital bed system" refers to a medical bed, regardless of the health care setting in which it is used. It should be noted that certain specialty bed systems will be considered exempt from the activities of the HBSW, and therefore are also exempt from this discussion:

Air-fluidized bed systems
Proning bed systems
Bariatric bed systems
Pediatric beds and cribs
Exam, OR, and other specialty tables and stretchers
Kinetic treatment tables (exempt from zones 1, 6, and 7)
Rotation bed systems (exempt from zones 1, 6, and 7)
Air flotation bed systems (exempt from zones 1, 6, and 7)
Labor/delivery/recovery/post-partum bed systems (exempt from zone 7) Overlays are not considered to be a part of the bed system.

"Entrapment" is defined here as the head or neck of the patient or resident becoming caught, trapped, or entangled in the bed system. This entrapment also carries the associated risk of serious injury or death. The scope of the Hospital Bed Safety Workgroup was limited to examining the issues related to entrapments, and restricted from looking at patient falls related to bed rails, although falls occur much more frequently than entrapments.

Entrapments may occur in a bed system because the original bed design did not appropriately address the risk. More commonly, however, bed system components may have been replaced or exchanged subsequent to their initial purchase, without consideration of the creation of a potential hazard.

Entrapments in hospital bed systems have been found to occur in a total of six zones.

Zone 1: Between the mattress and the bottom of the rail at rail end
Zone 2: Between the mattress and the bottom of the rail between rail supports
Zone 3: Between adjacent bars of a rail
Zone 4: Between the side of the mattress and the inside of a rail
Zone 5: The space between split rails
Zone 6: The space between the end of a rail and the head or foot board
Zone 7: Between the end of the mattress and the head or foot board

There have been no reported entrapment incidents in zone 7. Based on the statistics that the first four zones constitute 87% of the entrapment incidents, the HBSW has focused its primary efforts on zones 1-4.

This sounds like a terrible problem, but before reaching that conclusion, let's examine the statistics. According to the FDA, in the 16 year period between 1985 and 2001, there have been 439 incidents of entrapment in hospital bed systems, resulting in 271 deaths, and 98 non-fatal injuries. 85% of the deaths and injuries have occurred in individuals over 65 years of age. Only 38% have occurred in acute care hospitals.

Therefore, there are only 10.4 entrapment incidents in acute care hospitals each year, resulting in 6.4 deaths. Considering 5000 hospitals nationally, each hospital might therefore experience one entrapment incident every 500 years and one death every 1000 years. The probability of entrapment per hospital admission is 3.1 X 10-7, and that of death from entrapment is 1.9 X 10-7. These probabilities are less than that of a motor vehicle fatality or swimming fatality per hour of exposure.

In addition to these low probabilities, the FDA reports themselves are not always conclusive. In many cases, the health care setting (acute care, long term care, home care, etc.) in which the entrapment occurred is not clearly identified. Also, the information provided in the report may not specifically identify the applicable entrapment zone. In both of these instances, judgment calls were made to classify the specific incident. Furthermore, according to the Dimensional Guidance document, "It must be noted that the beds involved in the events may not have had mattresses or bed rails designed for that particular bed at the time of use; this may also not have been reported by the complainant. Also, there is no information about the condition of the beds, bed rails, and mattress at the time of the events. Finally, the descriptions of the events, as recorded in the FDA databases, are sometimes vague and inferences were made when trying to determine what happened and where the reported entrapment occurred."

Three documents will be forthcoming from the Hospital Bed Safety Workgroup. The first provides clinical guidance to evaluate patients for their risk of entrapment. Another provides corrective guidance, that is, suggestions to make adjustments to bed systems which do not comply with the remaining document, "Bed System Entrapment Dimensional and Assessment Guidelines." The clinical and corrective guidance will be published as documents of the HBSW. The Dimensional and Assessment Guidelines will be published as a guidance document of the FDA in the Federal Register.

The document of greatest concern is the Dimensional and Assessment Guidelines because these will be published in the Federal Register. It is important to understand that they are being published as guidance, rather than regulation, and therefore compliance is voluntary. However, due to the lack of another required standard, this guidance can be held in court as a de facto standard.

The dimensional guidance suggests that it provides guidance for manufacturers in the design of new bed systems, but also that it is one of several tools that may be used to assess systems currently in use in health care organizations.

According to the document, each bed system (combination of bed frame, mattress, and side rails) should be measured to assess the size of the four potential entrapment zones using the measurement tools described below. Note that not every bed need be measured if there are multiple beds with the same configuration, however, if a particular system passes only marginally, all beds in that configuration should be measured. If gaps or spaces appear to change as the bed is articulated to various positions, measurements should be taken at each position. It is suggested that one individual perform the measurements and another serve as the recorder. The bed should be made prior to performing the measurements, and the tool should be disinfected between bed systems.

To perform these measurements, the work group has developed a cone-and-cylinder tool, its size and weight based on anthropomorphic data to simulate the smallest adult head and neck diameter and associated body weight. A wedge has been constructed based on this data to perform the measurement of one of the four potential entrapment zones. A force gauge is also included. These tools will be available for purchase at a price of about $300. They will come with complete instructions for use and a training video.

A pilot study was conducted by the Veterans' Administration VISN 8 to assess the tools and process for measuring the hospital bed systems. The VA study measured a total of 351 beds and four individuals were involved in performing the measurements. Each bed took approximately 15 minutes to complete, with 23 beds being accomplished per person-day. Using these statistics, as applied to 2,000,000 acute care hospital beds nationally and an average maintenance salary (including benefits) of $25 per hour, national costs just to perform the measurements would exceed $17 million.

Statistics from this study were based on the earlier determinations of the HBSW, and therefore included measurements made of all seven potential entrapment zones. Time required to measure the four currently recommended zones, however is still estimated at 15 minutes per bed system.

The outcomes of the pilot study showed that nearly all beds measured failed to meet the dimensional guidance. In addition, three of the four workers involved in the measurements sustained workers' compensation injuries resulting from carrying the 15 pound tool.

So now you've measured your bed systems and determined that most of them do not meet the recommended measurements. You have determined that you have a potential risk involving the beds in your organization, and accordingly must take some action. The Dimensional Guidance document does not specify any time frames in which the violating beds must be brought into compliance. In fact, the preamble states, "existing bed systems are not defective, misbranded or adulterated merely because they do not meet one or more of the dimensions identified in this guideline." At this point, the organization would turn to the Corrective Guidance publication for suggestions to remediate the situation. Suggestions offered here include retrofits available from the bed system manufacturers, bolsters and spacers, side rail replacement or removal, rail covers, mattress replacement, etc. None of these items will be without cost to the organization.

Patient safety concerns are a top priority in health care organizations today, as well they should be. Preventable deaths should not happen in our health care organizations, and no one is opposed to taking action that will truly and significantly reduce adverse events. But compare the 6.4 annual deaths from entrapment in hospital bed systems to the 80,000 deaths from nosocomial infections and the 20,000 deaths from pressure ulcers. Based on a simple risk assessment, the priorities are self-evident.

Please review the "Bed Rail System Entrapment Dimensional and Assessment Guidelines" when they are published in the Federal Register this fall. ASHE will communicate with its membership when this happens. Following publication, there will be a 90-day public comment period during which individuals and organizations are encouraged to express their opinions of the document and its requirements to the FDA. Please take the opportunity to participate in this important advocacy issue and respond to the publication of this document.

FDA Statistics

While the FDA statistics indicate that bed rail entrapments are a very infrequent occurrence in acute care hospitals, they do present more of an issue for long term care (LTC) organizations. Most of the individuals involved in these incidents can be classified as elderly, frail, and confused. 85% of the entrapments are of those who are over 65 years of age. These individuals constitute a large of the resident population of long term care facilities, with 89.8% of the residents being over age 65, and 63% being disoriented or memory impaired.1 Therefore the entrapment issue merits additional consideration in the long term care setting.

62% of the 439 incidents and 271 deaths occurred in settings other than acute care. FDA statistics are not able to distinguish between settings in this group, and they may include some home care and other arenas. Given the population at risk, however, one may assume that the majority of these occurred in the long term care setting. With that assumption, one would arrive at the following statistics for long term care:

17 entrapment incidents annually
10.5 entrapment deaths annually
38.7 non-fatal incidents annually

Looking at the numbers alone, they are 1.6 times higher in long term care than acute care. Given that there are more than three times as many long term care facilities nationally than acute care facilities, the per-facility statistics are even lower than the per-hospital numbers. But because of the very nature of the long term care business, the number of admissions is much lower.

There are currently 1.5 million long term care residents in this country.1 To look at the LTC statistics on a per-resident basis, one can calculate a 1.1 X 10-5 probability of an entrapment incident and 7 X 10-6 probability of entrapment death. Admittedly, these are still low numbers, but the probability of entrapment is higher in long term care by two powers of ten, and death by approximately 1.3 powers of ten.

Furthermore, in LTC organizations, the beds themselves may not reflect the current design and technology. Due to their age, a variety of replacement parts and accessories may be in use, and the bed systems themselves may be more varied throughout the organization.

Therefore, in long term care facilities, a closer look should be taken at the issue of bed rail entrapments and the associated deaths. Following the measurement of bed systems, as in acute care hospitals, consult both the Clinical Guidance and the Corrective Guidance for strategies that may be appropriate in particular situations. For example, in long term care, removal of the rails entirely, or placing the bed close to the floor may be useful.

American Health Care Association website: www.ahca.org

Susan McLaughlin, MBA, CHSP, MT, (ASC), SC, ASHE consultant.

This article orginally appeared in inside ASHE for Today's Healthcare Engineer, Volume 10, Number 7, pages 22-25.