Posey Bed 8070 User Manual

Page 7

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Posey Bed 8070

7

All hospital beds pose safety and entrapment risks. The U.S. Food and Drug Administration (FDA)

received approximately 803 entrapment reports in the U.S. for standard hospital beds over a period

of 24 years from January 1, 1985 to January 1, 2009.

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The FDA formed the Hospital Bed Safety Workgroup (HBSW) to develop solutions to reduce the

risk of patient entrapment in hospital beds. The HBSW issued guidelines in 2006 describing seven

potential zones of entrapment and recommendations to reduce life-threatening entrapments

associated with hospital bed systems.

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The Posey Bed 8070 was designed to help eliminate each of the seven entrapment zones described

in the guidelines, when the head of the bed is down and the mattress is flat.

• Patients who, because of mental or physical disability, cannot reposition or remove him or

herself from a confined area in the bed.

• Any other patient identified by the physician, the care plan, or Interdisciplinary Healthcare

Team (IDHT) to be at risk of entrapment in the gaps created when the head of the Posey Bed is

up.

To help reduce the risk of entrapment, do the following:

• Keep the mattress flat.

– If you need to elevate the head or torso of an at-risk patient, keep the mattress flat and

use a cushion to position the patient.

– If you must leave the head of the bed up while an at-risk patient is unattended, use the

Posey Filler Cushions (Cat. 8021).

• Provide extra monitoring.

– Monitor patient per facility’s restraint protocol to ensure that the Posey Filler Cushions

cannot be removed by an at-risk patient and that an at-risk patient cannot crawl under

or around the Posey Filler Cushions.

• Avoid stretching the canopy material.

– The canopy may stretch over time during normal use, or due to patients who engage in

escape behaviors. This could result in pocket areas on the inside of the canopy. Regular

washing and drying should help reduce this condition.

DO NOt use any canopy that

has tears or damage and request a replacement.

If necessary, consult the physician or the IDHT to find an alternative method of treatment for any

at-risk patient.

Background

at-Risk Patients

Reducing the Risk

of entrapment

alternative method

of treatment

a special Note

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This report can be found at http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm164366.htm

4

Guidance for Industry and FDA Staff – Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. March 10, 2006). This report can be found at

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072662.htm

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