### Note of Clarification, March 20, 2003

> This research was conducted in 2001 when the Hospital Bed Safety
> Workgroup (HBSW) dimensional guidelines were under development. The
> dimensional guidelines and measurement methodology used here do not
> necessarily reflect current recommendations neither of the HBSW nor of
> the guidance document that will eventually be released by the FDA.
>
> For current information on the HBSW work, refer to:\
> [www.fda.gov/cdrh/beds
> \<]{.underline}<http://www.fda.gov/cdrh/beds>[\>]{.underline}
>
> For information about the availability of the toolkit, refer to:\
> [www.ecri.org/bedsafety \<http://www.ecri.org/bedsafety\>]{.underline}

Hospital Bed Safety Evaluation in Hospitals and Nursing Homes

[[**Investigators:**]{.underline}]{.smallcaps} G. Powell-Cope[^1], A.
Nelson^1^, S. Hoffman^1^, M. Tate[^2], L. Rathvon^1^, D. Bradham[^3], S.
Luther^1^

**[[Introduction]{.underline}:]{.smallcaps}** The Veterans Health
Administration is committed to improving patient safety. The VHA-funded
center based in Tampa FL, The VISN 8 Patient Safety Center of Inquiry,
focuses on safe patient mobility for frail elderly and the disabled. In
2000, our center partnered with the Food and Drug Administration (FDA)
and representatives from the medical bed industry, national health care
organizations, patient advocacy groups, and other federal agencies
(Health Care Finance Administration; Consumer Product Safety Commission)
to improve the safety of hospital beds for patients who are most
vulnerable to the risk of side rail entrapment.

**[[Problem Statement]{.underline}]{.smallcaps}**: Hospital bed systems
can contribute to significant injury or death. Today there are about 2.5
million hospital and nursing home beds in use in the United States.
Between 1985 and 1999, 371 incidents of patients caught, trapped,
entangled, or strangled in beds with rails were reported to the U.S.
Food and Drug Administration. Of these reports, 228 people died, 87 had
a nonfatal injury, and 56 were not injured because staff intervened.
Most of these patients were frail, elderly, or confused. Generally, it
is assumed that most of these "close calls" are not reported. The FDA
Hospital Bed Safety Workgroup developed a set of proposed guidelines
that specify dimensional criteria for bed systems based on 15
anthropometric data sources and a retrospective validation based on a
survey of past entrapment events.

**[[Research Objectives:]{.underline}]{.smallcaps}** The goal of this
six-month study using prospective observational and survey methods is to
minimize risk of death and injury due to bed-related entrapment of
patients. The purpose of the study is to (1) evaluate a facility-based
approach for bed safety assessment (2) determine evidence-based
recommendations for intervention (3) determine relative risk and cost
benefit comparison of interventions. An observational descriptive design
will be used in the proposed study. The following **immediate
objectives** (O) will be addressed:

> **O1:** Determine the variability/frequency distribution/prevalence of
> bed systems (components of which include characteristics of rails,
> foot and head boards, beds and mattresses; models; manufacturers; bed
> modifications; bed rail alternatives) at six VA health care systems.

**O2:** Evaluate each bed according to proposed safety criteria in seven
critical "bed-safety zones".

**O3:** Empirically refine the process for measuring beds according to
the proposed safety criteria in each of the seven critical areas.

**O4:** Estimate the incidence and etiology of bed-related adverse
events including close calls, injuries, and deaths.

**O5:** Evaluate the attributable risk of each bed system and its
sub-components for each outcome using a decision analytic model.

**O6:** Design a system for prioritizing interventions to improve bed
safety based on risks, benefits (avoided cost of morbidity and
mortality), and cost of interventions.

**O7:** Develop a strategic plan to mitigate the bed-related patient
risks identified in VISN 8.

[**[Methods: Overview.]{.underline}**]{.smallcaps} Initially a pilot
study for Objectives 1 through 3 will be conducted at the Tampa VAMC to
finalize data collection processes and evaluate the surveys. Once
methods are standardized similar data will be collected all VAMCs in
VISN 8. Observational and survey methods will be used to address
objectives 1-3. Trained data collectors will measure seven predetermined
critical areas including gaps within side rails, distances between
mattresses and side rails and between mattresses and head/footboards. To
address objective 4 and 5, patient specific administrative information
will be collected using the VHA's national Austin Automation Center
(AAC) databases on all patients occupying a bed over the data collection
period in long term care and medical/surgical units at Tampa VA only
over a 45 day period. We will also review one year's worth of incident
reports of bed-related entrapment from each VAMC in VISN 8 and VISN 16.
During this period a standardized instrument will be used to collect
data on all falls from bed, entrapments, and close calls. To address
objectives 6 and 7 an expert panel will review results of the VISN-level
data and determine evidence-based priorities and a strategic plan to
mitigate risks in VISN 8.

**[[Anticipated Impact:]{.underline}]{.smallcaps}** The immediate
outcome of this proposed Bed-Safety evaluation in VISN 8 pilot research
is a reduction in patient risk of injury and entrapment related to bed
systems. The result of this investigation will be an evidence-based
decision making process on the replacement of bed systems. This process
can be used to standardize purchasing through consolidated contracting
based on an assessment of risk, benefit and cost. This proposed work
extends the work of the FDA Bed Safety Working Group by validating and
streamlining measurement procedures, providing the basis for training
programs, and identifying processes for facilities to use in determining
cost/benefits of mitigation strategies. Potential non-VHA users of data
generated from this proposed study are the FDA, HCFA, JCAHO, and private
industry.

**[[Attachment 1. Seven Potential Entrapment Zones Related to
Bedrails]{.underline}]{.smallcaps}**

Bedrail use is a practice issue of growing concern to clinicians and
administrators. Based on 102 incidents of head and body entrapment
resulting in sixty-eight deaths and twenty-two injuries, the Food and
Drug Administration (FDA) issued a Safety Alert in 1995 concerning
hazards related to bedrails. All deaths involved entrapment of the head,
neck, or thorax while most injuries involved fractures or lacerations of
the extremities. Drs. Parker and Miles (1997) analyzed 74
bedrail-related deaths form the Unites States Consumer Project
Commission files and found that 70% of victims were asphyxiated between
the bedrail and the side of the mattress. Also, many bedrails have wide
gaps within the rails that can lead to entrapment injuries (Capezuti,
2000). Several recently published newspaper articles have reported the
risks associated with bedrails and have prompted public attention to
this issue (Braun and Capezuti, 2000a; a refers to IBJ v. b refers to
DePaul Jl of HC Law). Figure 1 shows the areas where bed rail entrapment
is most likely to occur.

[Entrapment Zone 1 (H)]{.underline} [Entrapment Zone 2 (I)]{.underline}
[Entrapment Zone 3 (A)]{.underline}

![](media/image1.png){width="1.7138888888888888in"
height="1.9222222222222223in"}
![](media/image2.png){width="2.109027777777778in" height="2.03125in"}
![](media/image3.png){width="2.2645833333333334in"
height="1.4659722222222222in"}

[Entrapment Zone 4 (D)]{.underline} [Entrapment Zone 5]{.underline} (E)
[Entrapment Zone 6 (F)]{.underline}

![](media/image1.png){width="1.3743055555555554in"
height="1.6611111111111112in"}
![](media/image4.png){width="1.5027777777777778in"
height="1.6201388888888888in"}
![](media/image5.png){width="1.9569444444444444in" height="1.4375in"}

[Entrapment Zone 7 (J)]{.underline}

![](media/image6.wmf)

**[[Attachment II: Background Information: The Hospital Bed Safety
Working Group]{.underline}]{.smallcaps}**

This workgroup was established in 1999 at the Department of Health and
Human Services in Washington DC under the leadership of the Food and
Drug Administration. The goal of the group is to reduce the risk of
entrapment and injuries related to hospital beds, focusing on bed rails
through standardization of definitions, standardization of the
evaluation of beds, mattresses and side rails, and outreach to providers
and patients. The working group is composed of representatives from
government (including the VHA), professional and regulatory agencies
(including HCFA, JCAHO), health care organizations, patient advocacy
groups, and private industry. To date, the group has (1) reconciled
regulatory definitions and requirements related to hospital beds; (2)
authored "Universal Clinical Guidance for the Assessment for Use and
Implementation of Hospital Bed Side rails in Hospitals, Long Term Care
Facilities and Home Health Settings (not finalized as of April 2001);
(3) developed a resident/family brochure on risks of side rails and
alternatives to their use (posted on FDA website,
(<http://www.fda.gov/cdrh/beds/index.html>) , and (4) proposed standards
for seven bed system (bed/mattress/rail) measurements. These proposed
measurement standards were systematically developed based on 1^st^ and
5^th^ percentiles for head, neck, chest measurements, then validated
using actual entrapment data (Table 1).

It is expected that these measurement criteria will be submitted to the
FDA in June 2001 for consideration as an FDA Guidance. The criteria were
developed to be consistent with what the group believed will be
international standards at a later date.

##### Table 1. Seven "Bed Safety Zones" and Recommended Measurement Criteria

+-------------------------+--------------+---------------+------------+
| **BED-SAFETY ZONES**    | **HEAD       | **NECK        | **CHEST    |
|                         | BREADTH\     | DIAMETER\     | DEPTH\     |
|                         | \< 120 mm**  | \< 60 mm**    | \> 318     |
|                         |              |               | mm**       |
+-------------------------+--------------+---------------+------------+
| (1) Rail to mattress,   |              | **\***        |            |
|     horizontal          |              |               |            |
|     measurement (H)     |              |               |            |
+-------------------------+--------------+---------------+------------+
| (2) Board to mattress,  |              | **\***        |            |
|     horizontal          |              |               |            |
|     measurement (I)     |              |               |            |
+-------------------------+--------------+---------------+------------+
| (3) Within rail (A)     |              |               |            |
+-------------------------+--------------+---------------+------------+
| (4) Rail to bed end     |              |               |            |
|     (board), both ends, |              |               |            |
|     60 \> D \> 318 (D)  |              |               |            |
+-------------------------+--------------+---------------+------------+
| (5) Between split rails |              |               |            |
|     60 \> E \> 318 (E)  |              |               |            |
+-------------------------+--------------+---------------+------------+
| (6) Top of compressed   |              |               |            |
|     Mattress to bottom  |              |               |            |
|     of rail, at ends of |              |               |            |
|     rail\*\* (F)        |              |               |            |
+-------------------------+--------------+---------------+------------+
| (7) Top of compressed   |              |               |            |
|     Mattress to bottom  |              |               |            |
|     of rail, between    |              |               |            |
|     rail supports (J)   |              |               |            |
+-------------------------+--------------+---------------+------------+

**Note**: All dimensions are measured with bed in typical patient care
positions except for Zones 1 and 4 which are measured in the flat bed
position only

\* allows for mattress compression by head

\*\* End of rail is defined as the length of rail that extends beyond
the rail support / post

**[[Attachment III: Procedure for Measurement of Entrapment
Zones]{.underline}]{.smallcaps}**

A *Bed System Evaluation Toolkit* was developed by the FDA Bed Safety
Working Group and includes a tape measure (to measure critical areas), a
specially designed cone shaped device (to measure 2 1/3, 4 ¾, and 12 ½
inch spaces), a fish scale (to exert a predetermined force), and a
weight to exert mattress compression that simulates the shoulder of a
170 pound adult.

Table 2. Evaluation Procedures for each Entrapment Zones

+------------+-------------------------------------------+------------+
| **[        | #                                         | **[        |
| Entrapment | ##### [Evaluation Procedures]{.smallcaps} | Definition |
| Zone]{.sm  |                                           | of         |
| allcaps}** |                                           | "          |
|            |                                           | Pass"]{.sm |
|            |                                           | allcaps}** |
+------------+-------------------------------------------+------------+
| (1) Rail   | ## Place bed in                           | ## Di      |
|     to     |  flat position, elevate side rails. (Elev | stance is  |
|            | ate head end rails only for split rails.) | less than  |
|  mattress, |                                           | 2 1/3 inch |
|            | ## P                                      | es (60 mm) |
| horizontal | ush mattress against opposite side rails. |            |
|     m      |                                           |            |
| easurement | ## W                                      |            |
|     (H)    | ith tape measure, measure the horizontal  |            |
|            | distance between the side of the mattress |            |
|            |  and the inside surface of the side rail. |            |
|            |                                           |            |
|            | ## Repeat with head and knee elevated     |            |
+------------+-------------------------------------------+------------+
| (2) Board  | ## Place bed in flat position.            | ## Di      |
|     to     |                                           | stance is  |
|            | #                                         | less than  |
|  mattress, | # Ensure bed ends are properly installed. | 2 1/3 inch |
|            |                                           | es (60 mm) |
| horizontal | ## Push matt                              |            |
|     m      | ress to opposite end for each measurement |            |
| easurement |                                           |            |
|     (I)    | ## With tape measure,                     |            |
|            | measure the horizontal distance between t |            |
|            | he end of the mattress and the inside sur |            |
|            | face of the bed end at head and foot end. |            |
+------------+-------------------------------------------+------------+
| (3) Within | ## Place                                  | Pass: Cone |
|     rail   |  bed in flat position, elevate side rails | does not   |
|     (A)    |                                           | pull past  |
|            | -   Insert cone in the maximum space      | 4 ¾" (120  |
|            |     within each rail. Attempt to pull     | mm)        |
|            |     cone through rail with 12 lbs of      |            |
|            |     force                                 |            |
+------------+-------------------------------------------+------------+
| (4) Rail   | ## Place                                  | ##         |
|     to bed | bed in flat position, elevate side rails. | Cone does  |
|     end    |                                           | not pull p |
|            | ## Insert cone between the side ra        | ast 2 1/3  |
|   (board), | il and bed end at the head and foot end.  | " (60 mm)  |
|     both   |                                           |            |
|     ends,  | ## Attempt to pull cone through           | Cone       |
|     60 \>  | the maximum space from the inside of the  | passes     |
|     D \>   | bed to the outside with 12 lbs. of force. | freely     |
|     318    |                                           | through \> |
|     (D)    | #########  OR                             | 12.5" (318 |
|            |                                           | mm)        |
|            | ## Alternatively, turn cone sideways      |            |
|            | and attempt to pull through minimum space |            |
+------------+-------------------------------------------+------------+
| (          | ## Place                                  | Cone does  |
| 5) Between | bed in flat position, elevate side rails. | not pull   |
|     split  |                                           | past 2     |
|     rails  | ## Insert cone a                          | 1/3" (60   |
|     60 \>  | t the maximum point between split rails.  | mm)        |
|     E \>   |                                           |            |
|     318    | ##                                        | Cone       |
|     (E)    | Pull cone through from the inside of the  | passes     |
|            | bed to the outside with 12 lbs. of force. | freely     |
|            |                                           | through \> |
|            | ######### OR                              | 12.5" (318 |
|            |                                           | mm)        |
|            | #                                         |            |
|            | # Alternatively, turn cone sideways and a |            |
|            | ttempt to pull through the minimum space. |            |
|            |                                           |            |
|            | ## Repeat with head and knee elevated     |            |
+------------+-------------------------------------------+------------+
| (6) Top of | ## Pl                                     | Distance   |
|            | ace bed in flat position, elevate side ra | is less    |
| compressed | ils, push mattress towards opposite side. | than 2     |
|            |                                           | 1/3" (60   |
|   Mattress | ##                                        | mm)        |
|     to     |  Have 170 lbs person lie on his/her side  |            |
|     bottom | on mattress at edge of mattress. Have per |            |
|     of     | son's shoulder positioned at end of rail. |            |
|     rail,  |                                           |            |
|     at     | ## With ta                                |            |
|     ends   | pe measure, measure the diagonal distance |            |
|     of     |  from the top of the compressed mattress  |            |
|            | to bottom of rail at the end of the rail. |            |
|   rail\*\* |                                           |            |
|     (F)    | -   Repeat with head elevated.            |            |
+------------+-------------------------------------------+------------+
| (7) Top of | ## Pl                                     | Distance   |
|            | ace bed in flat position, elevate side ra | is less    |
| compressed | ils, push mattress towards opposite side. | than 4 ¾"  |
|            |                                           | (120 mm)   |
|   Mattress | ## Have 1                                 |            |
|     to     | 70 lbs person lie on his/her side on matt |            |
|     bottom | ress at edge of mattress. Have person's s |            |
|     of     | houlder positioned between rail supports. |            |
|     rail,  |                                           |            |
|            | ## With t                                 |            |
|    between | ape measure, measure the diagonal distanc |            |
|     rail   | e from the top of the compressed mattress |            |
|            |  to bottom of rail between rail supports. |            |
|   supports |                                           |            |
|     (J)    | -   Repeat with head elevated.            |            |
+------------+-------------------------------------------+------------+

[^1]: VISN 8 Patient Safety Center of Inquiry, Tampa VAMC, Tampa FL

[^2]: VISN 16, Jackson, MS

[^3]: Baltimore VAMC, Baltimore MD