User Manual

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Posey Bed 8060 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.
3
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.
4
The Posey Bed 8060 was designed to help eliminate each of the seven entrapment zones when the
canopy is used with a compatible hospital bed at the lowest acceptable height (16 or 17 inches from
the floor to the deck of the bed) 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 doctor, 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 8060 is
up.
To help reduce the risk of entrapment, do the following:
• Keep the mattress flat.
– If you need to elevate the head or body of an at-risk patient, while the patient is
alone, keep the mattress flat and use a Posey Torso Cushion (Cat. 8025) to position the
patient.
– If you must leave the head of the bed up for an at-risk patient (for example, while
watching TV or if called for by the doctor’s order, or the patient’s care plan, use the
Posey Filler Cushions (Cat. 8021) and provide extra monitoring.
• 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 try to
escape. 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 doctor or the IDHT to find a different method of treatment for any at-risk
patient.
Background
At-Risk Patients
Reducing the Risk
of Entrapment
Alternative Method
of Treatment
A Special Note
3
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