Regulatory Guide

Bed Entrapment Guide: The 7 Zones of Entrapment, Bed Rails, Bed Entrapment Tool and Assessing Risk

MATTRESSES, BEDS | Last Updated on November 01, 2020

Direct Supply Bed & Mattress

Table of Contents

Help Prevent Injuries and Save Lives

Protecting your residents from bed entrapment

The U.S. Food and Drug Administration (FDA) has partnered with representatives from the hospital bed industry and other parties to form the Hospital Bed Safety Workgroup (HBSW). The HBSW has guidelines in place to help you prevent bed entrapment by identifying areas of risk – areas both on the bed and on the body. These guidelines will help you select a bed system to help protect your diverse resident population.

What is Bed Entrapment?

Bed entrapment is a situation where a resident is caught by their head, neck or chest in the tight spaces around the bed rail. It can happen when a vulnerable resident attempts to move within or exit his or her bed without assistance. This can be due to a number of reasons, including acute urinary retention, delirium, confusion, pain or agitation.

Bed entrapment is a real concern in Long Term Care facilities and, unfortunately, can result in serious injuries and even death.

From 1985 to 2009, the FDA received approximately 803 entrapment reports – 480 of which resulted in death. Reports have also identified the most vulnerable population to be the elderly, especially those who are frail, confused, restless and those who do not have full control over their body movements.

To help reduce bed entrapment injuries, the FDA defined the 7 zones of entrapment, or spaces, around healthcare beds where patients could become trapped. Addressing potential issues within the zone can help reduce potential bed injuries.

FDA Bed Entrapment Guidelines Overview

In 2006, the FDA took action to reduce the risk of hospital bed entrapment by issuing guidance to the healthcare industry. In the guidance literature, the Hospital Bed Safety Workgroup (HBSW) (a partnership among FDA, the medical bed industry, national health care organizations, patient advocacy groups, and other federal agencies) published three sets of guidelines related to clinical, dimensional and mitigation concerns.

  • Clinical guidelines : help caregivers assess whether bed rails are appropriate and necessary for a resident’s bed system
  • Dimensional guidelines : help caregivers identify the dangerous zones within the bed system where entrapment may occur
  • Mitigation guidelines : help caregivers modify their existing bed systems as needed to make them safer

These guidelines are intended to help ensure that those inspecting entrapment cases are well-equipped with the right tools to accurately assess the root of the incidence and determine liability for any injury or fatality. Considering the guidelines and the eldercare population, it’s important that you familiarize yourself with ways to protect your residents and your business from bed entrapment.

What Systems do the Dimensional Guidelines Reference?

Diagram of Bed Entrapment Zones

These FDA entrapment guidelines refer to all existing bed systems in the field, commonly referred to in eldercare as “legacy” beds. The guidelines also take into account the entire bed system, including the bed frame, mattress and any bed accessory such as rails, and any other piece that can be attached to the bed. Changing individual elements to the bed system can mean the difference between a safe bed system and an unsafe one. Luckily, you have product options available that can improve your bed’s safety and reduce the risk of entrapment.

There are some areas of consideration that are excluded from FDA entrapment guidelines. Bariatric beds are excluded because of the different needs and body shapes of bariatric residents. The use of a powered air mattress is viewed as a partial exclusion. They are excluded from the dimensional limit recommendations, except for spaces within the perimeter of the rail (Zone 1). When powered air mattresses are used, the FDA recommends steps are taken to ensure that the therapeutic benefit outweighs the risk of entrapment. Even though bariatric beds and powered air mattresses are excluded from entrapment guidelines, be sure to exercise caution when using these products as entrapment concerns may still be relevant.

Zone 1: Within the Rail

Bed Entrapment Zone 1
Bed Entrapment Zone 1

Any open space between the perimeters of the rail can present a risk of head entrapment. The FDA recommends a space of less than 4¾".

Zone 1 Solutions : Mesh side-rail protectors and vinyl bed rail pads can be added to help reduce potential entrapment areas in Zone 1. Mesh side rails protectors fit snugly over rails to cover any gaps, and the vinyl bed rail pads can be attached to bed rails with Velcro closures.

Zone 2: Under the Rail, Between the Rail Supports or Next to a Single Rail Support

Bed Entrapment Zone 2
Bed Entrapment Zone 2

The gap under the rail between the mattress may allow for dangerous head entrapment. FDA recommended space: less than 4¾".

Anti-Entrapment Bedrail Pad

Anti-Entrapment Bedrail Pad

NYOrtho Anti-Entrapment Bedrail Pad

Split-Rail Vinyl Bedrail Pads

Split-Rail Vinyl Bedrail Pads

NYOrtho Split Rail Vinyl Bedrail Pad

Zone 3: Between the Rail and the Mattress

Bed Entrapment Zone 3
Bed Entrapment Zone 3

If the area between the inside surface of the bed rail and the mattress is too large, it can cause a risk of head entrapment. The FDA recommends a space of less than 4¾".

Zone 4: Under the Rail at the Ends of the Rail

Bed Entrapment Zone 4
Bed Entrapment Zone 4

A gap between the mattress and the lowermost portion of the rail poses a risk of neck entrapment. The FDA recommends a space of less than 2⅜".

Zone 5: Between Split Bed Rails

Bed Entrapment Zone 5
Bed Entrapment Zone 5

When partial length head and split rails are used on the same side of the bed, the space between the rails may present a risk of either neck or chest entrapment.

Zone 6: Between the End of the Rail and the Side Edge of the Head or Foot Board

Bed Entrapment Zone 6
Bed Entrapment Zone 6

A gap between the end of the bed rail and the side edge of the headboard or footboard can present the risk of resident entrapment.

Zone 7: Between the Head or Foot Board and the End of the Mattress

Bed Entrapment Zone 7
Bed Entrapment Zone 7

When the space between the inside surface of the headboard or footboard is too large, the risk of head entrapment increases.

Note: Currently, the FDA provides dimensional recommendations for zones 1-4, as 80% of reported entrapment cases have occurred in these zones.

Are Bed Rails the Best Choice for Your Residents?

Factors to Consider

Though bed rails can serve a variety of resident health and safety purposes, they may also pose a threat to resident safety if they are not absolutely needed. According to the Hospital Bed Safety Workbook (HBSW), caregivers should conduct an assessment to determine if bed rails are necessary for residents.

The HBSW recommends using an interdisciplinary team of staff members and conversations with family members to evaluate the resident’s medical needs and ailments. After this is done, the assessment process should include (but is not limited to) an individualized resident assessment, a sleeping environment assessment and treatment programs and care plans.

The following assessment considerations are not applicable to federal, state or local regulations; they are only meant to assist your staff in making decisions about individualized care plans for residents.

Assessment Considerations

The HBSW considers a resident to be at low risk of injury when he or she:

  • Can move to and from the bed to a wheelchair without assistance
  • Can move to and from the toilet without assistance
  • Is assessed to be unlikely to fall
  • Is able to effectively use call alarms

In these instances, the HBSW suggests considering using a bed without a bed rail for this type of resident.

The HBSW considers a resident to be at high risk of injury when he or she:

  • Cannot move safely from a bed to a wheelchair
  • Cannot move safely from the toilet without assistance
  • Has had a previous entrapment episode
  • Has had previous bed-related injuries, or has fallen from a bed
  • Has had difficulties using call alarms

For high-risk residents, the HBSW recommends an adjustable-height low bed, and supplying a high impact-absorbing bedside mat to prevent injury from falls.

If an adjustable-height low bed is not available, consider adding a quarter rail or transfer device to the fixed-height low bed for support. If bed rails must be used, carefully evaluate entrapment zone dimensions and explore mitigation solutions to lessen risk.

Bed Rails as Restraints

When bed rails serve no medical purpose, the HBSW recommends they should be avoided and less restrictive interventions should typically be used. When bed rails keep residents from voluntarily getting out of bed, they are deemed physical restraints.

Resident Choice

If a resident, family member or other authorized representative requests that bed rails be used, but the interdisciplinary team has ruled that rails are inappropriate, discuss the risks with all parties involved. The resident’s right to be involved in their own care plan must be balanced with your duty to provide superior quality care in accordance with applicable state and federal regulations and guidelines.

As always, it’s imperative that you educate and train all involved parties (i.e., residents, families, staff and regulatory representatives) about appropriate bed rail use.

Review the complete dimension guidelines as issued by the FDA.

Bed Rail Alternatives

How to Mitigate the Danger of Falls

Discontinuing the use of bed rails greatly reduces the chance for bed entrapment, but leaves residents vulnerable to potential injuries from falls. Luckily, there are various safety alternatives suggested by the HBSW you can use to help prevent falls and protect your residents when they don’t need or use bed rails.

Solutions to reduce fall risk:

  • Adjustable-height low beds are a restraint-free alternative for residents who are at risk of falling out of bed. The lower bed heights are ideal for ingress and egress as well as safer sleeping.
  • Bolstered mattresses reduce the risk of resident falls from bed by providing a raised “buffer” between residents and the edge of the bed.
  • Bed alarms alert caregivers when at-risk residents attempt to exit the bed so assistance can be provided.
  • Bedside mats can help protect against trauma and reduce the risk of injury by lessening the impact of falls in the unfortunate event one occurs.

Adjustable-Height Low Beds
Panacea ® 1000 Adjustable Height Bed, RIL, Laminate Panels, Half Rails, 450 lbs. Weight Capacity
Panacea ® 3250 Adjustable-Height Low Bed, Mobile at Any Height, with Safety Lock and Laminate Panels
Panacea ® 3500 Adjustable Height Bed, Mobile at Any Height, Laminate Panels
820DLX Adjustable Height Bed, Roll in Low, 36"Wx76-80"L, Grid Deck, 450lb Capacity

Bolstered Mattresses
Panacea ® Support Plus Foam Mattress 35"W x 80"L x 6"H, Heel Slope

Bed Alert
Attendant ® Deluxe Alarm

Bedside Mats
Panacea Foldable Bedside Mat, 24"W x 70"L

Solutions to aid residents with repositioning:

Trapezes and assist devices give residents firm support to help them safely reposition themselves in bed.

Offset Trapeze Bar, Octagon Tube
Trapeze Floor Stand for #54638

Assist Devices
Single Halo Safety Ring for Panacea 1500 Beds
Halo Safety Ring for Panacea 1500 Beds, Pair

Solutions to aid residents with ingress and egress:

Assist devices offer residents support and stability when entering and exiting their bed

Assist Devices
Single Halo Safety Ring for Panacea 1500 Beds
Halo Safety Ring for Panacea 1500 Beds, Pair

Assessing Your Existing Beds for Bed Entrapment Risks

Legacy Beds Guidelines

The threat of bed entrapment within bed rails, bed frames or mattresses is serious, and can result in debilitating chest, head or neck injuries – sometimes even resulting in death. That’s why it’s important to take every step to reduce the risk of entrapment, in accordance with the dimensional criteria for bed systems, quality assurance and staff and family education.

The Hospital Bed Safety Workshop – or HBSW – has developed mitigation guidelines to help facilities reduce entrapment risks in existing hospital bed systems, or legacy beds. These bed entrapment assessment guidelines are intended to be used along with clinical resident assessments, and focus on modifying your current beds to make them safer for residents.

Mitigation Guidelines & Solutions

The HBSW’s Steps to Safety in Your Legacy (Existing) Beds

Step 1: Assign Responsibility
Assemble a small, interdisciplinary group of staff members responsible for reducing entrapment risks by measuring existing bed systems and determining effective solutions.

Step 2: Determine High-Risk Clinical Units (if appropriate)
When facilities have multiple units serving different resident populations with varying clinical needs, determining which units are at a high risk of entrapment helps to determine bed replacement strategies.

High-risk units have residents with higher acuity levels, lower resident visibility and those with resident monitoring challenges due to staffing shortages.

Step 3: Inventory Bed Systems
By tracking current beds in use in your facility, you can identify any need for bed replacements as well as the need for new assistive devices.

Step 4: Evaluate Bed Systems for Conformance to FDA’s guidelines
Use the FDA Dimensional Guidelines to identify entrapment risk zones.

Use the HBSW Bed Safety Entrapment Kit (shown below) to test the four most dangerous bed zones in a pass/fail assessment fashion. Review the complete dimension guidelines as issued by the FDA.

Bed System Measurement Devices
Bed Entrapment Tool

Step 5: Initiate Corrective Actions

  • Work with manufacturers: provide them with your bed inventory and ask for appropriate retrofits to correct entrapment in Zone 1
  • If retrofits are not available, replace bed rail with one that meets both the manufacturer’s and HBSW’s recommended dimensions, or cover existing bed rails with see-through rail covers that close the openings in Zones 1 & 5 (see-through covers will allow your residents to see out of the bed, while allowing your staff to see the resident)
  • Accurately measure the length, width, depth, compressibility and physical characteristics of your mattresses to ensure spaces fit into the FDA recommended dimensions in Zones 2, 3 & 4 and reduce openings in Zone 7
  • Also consider lowering or removing bed rails completely, or replacing full length or older rails with newer, shorter assist rails to reduce entrapment in Zones 1-6. Always assess entrapment risks for new or replacement rails
  • Reduce risk of entrapment in Zone 3 by placing foot end rails in lowest position or by removing foot end bed rails (this will eliminate any unnecessary burden on your nursing staff and also eliminates Zone 5 entrapments)
  • If no retrofit, replacement or mitigation solutions exist, it may be necessary to replace the bed system

Step 6: Guidance for Purchasing Beds
An integrated approach that considers the inventory of existing beds, options for corrective actions and quality monitors will assist in long-range planning for bed safety. Bed purchases will be most successful from cost/benefit and safety perspectives when purchasers, managers and interdisciplinary staff work together to balance resident and environmental risk factors, resident and staff preferences and cost.

Step 7: Implement Quality Monitoring Once corrective actions have been taken to reduce the risk of entrapment in your facility, it will be necessary to closely monitor plans of action to ensure your residents stay protected; monitoring should continue on an ongoing basis.

Direct Supply Can Help You Solve Bed Entrapment Challenges

Shop our full offering of beds and accessories or call 1-800-634-7328 for help selecting products, questions or how we can help you develop a beds program to help protect you and your residents from bed entrapment.