Hazard with Hospital Bed Split Side Rails

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Contact: MDB Enquiries

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No. 107 August 10, 1995

To: Hospital Administrators Nursing Homes / Homes for the Aged

Subject: Hazard with Hospital Bed Split Side Rails

Recently, the Health Protection Branch has received several reports of patient entrapment between hospital bed split side rails. Four of these have led to patient deaths and were similar in that the patient was entrapped between the rails, often at the thorax. In at least 3 of the 4 deaths, the patient was confused or agitated. In most cases, the split rails involved were of the parallelogram design (see figure). In the United States, there were 2 similar cases between 1990 and 1994, one resulting in death.

There are no regulations specific to hospital beds in either Canada or the United States. However, standard NQ 6641-120 "Lits d'hôpital à commandes manuelles" published by the Bureau de normalisation du Québec (BNQ) specifies a maximum space of less than 120 mm (about 4.7") between the lateral tubing of the two split rails.

On the basis of recent Bureau research into anthropometric data and actual measurement of neck widths, the Medical Devices Bureau now recommends that for a horizontal deck position the spacing at any point between split rails of the parallelogram, rectangular, or other design should be able to be closed to 60 mm or less. This recommendation is now contained in a draft Guideline for manually adjustable and electric institutional beds, currently being drafted by the Bureau in cooperation with a working group composed of users and manufacturers. The distance between split rails should be measured at the angle shown in the above figure.

The draft Guideline also recommends that if the 60 mm gap is achieved by the use of a removable protective barrier, the space should be no more than 100 mm when the barrier is removed. For any deck position other than horizontal, the Guideline recommends that the spacing between the split rails, which will vary during articulation of the mattress deck, should be such that entrapment, pinching or accidental falling out of bed are minimized. Actual dimensions for the spacing between the rails for these other deck positions are being discussed but the variety of possible positions and different rail designs as well as possible new innovative rail designs may make the specification of actual dimensions undesirable or unfeasible.

Currently, few if any manufacturers meet the recommended 60 mm maximum spacing without use of a protective barrier. The distance between split rails currently sold can vary between 150 mm and 330 mm (6" and 13"), depending on the type of rail and the location of the measurement. At least two manufacturers (Bertec Médical Inc. and HillnRom) offer as accessories protective barriers to block the opening between the rails.

Minimal spacing between split rails or use of protective barriers may not be appropriate for some patients who may be determined to get out of bed and who when faced with a "fullnlength" rail, will attempt to climb over it. Some split rails are designed to allow sufficient space between them to permit patient egress and ingress. However, some patients move a great deal during sleep and therefore in some cases, minimal spacing or barriers is necessary. Thus, the Branch feels that the rail system should allow closing this space to 60 mm or less for maximum protection of agitated or restless patients. It should be emphasized that side rails should not be used as a restraint system for a truly agitated or confused patient.

The Health Protection Branch recommends the following precautions:

1. Keep side rails in the fully raised position and the deck horizontal in its lowest position when the patient is sleeping unless the patient's medical conditions dictates otherwise.
2. If split side rails are being used and there is concern that the patient may accidentally go through the space between them, ensure that the bed has, in the horizontal deck position, a space of at most 60 mm between the split rails or use a protective barrier recommended by the manufacturer of the bed and rail system to reduce the opening to 60 mm or less.
3. Never use side rails as a means to confine or restrain the patient. If the patient is agitated or confused, consider the use of a restraint vest. Use restraints carefully and follow the manufacturer's instructions as improper usage of these have led to patient deaths. If a restraint vest is used, a seizure pad or other protector should be used and more frequent patient monitoring is recommended.

The Bureau's hospital bed guideline will address several contentious issues such as spacing between the headboard and side rail, spacing between the mattress and bottom of side rails, mobility of the bed, use of 3/4 length rails, etc. Readers who have concerns, comments or suggestions on these or other Guideline issues, may send them to the address below.

Inquiries concerning this hazard and reports of similar accidents should be addressed to the Director, Medical Devices Bureau, Room 1605, Statistics Canada Main Building, Tunney's Pasture, Postal Locator: 0301H1, Ottawa, Ontario, K1A 0L2. Telephone: (613) 957-4786, Fax: (613) 957-7318. Medical device problems may also be reported through the tollnfree Medical Devices Hotline at 1-800-267-9675.

Kent R. Foster
Assistant Deputy Minister

^© Minister of Supply and Services, 1995