Entrapment And Compliance Information - Graham Field Basic American MATRIX Series Instructions For Use Manual

ENTRAPMENT AND COMPLIANCE INFORMATION

On April 10, 2006, the FDA (U.S. Food and Drug
Administration) released long-awaited guidelines for reducing
the risk of bed entrapment: "Hospital Bed System Dimensional
and Assessment Guidance to Reduce Entrapment". The new
Guidance identifies potential entrapment areas and those
body parts most at risk for entrapment; provides design
criteria for manufacturers of new hospital/convalescent beds;
recommends particular test methods to assess the conformance
of existing hospital / convalescent bed systems; and answers
frequently-asked questions about entrapment issues.
The new Guidance was a result of a long-standing
collaboration between the FDA and the Hospital Bed Safety
Workgroup (HBSW), formed in 1999. GF Health Products,
Inc.'s Long Term Care Bed division: Basic American Medical
Products, is an HBSW charter member. As a result of our
commitment to product safety, all our current long-term
care beds have been strictly tested and conform to the new
FDA Guidance.
The guidelines set forth by the FDA Guidance lay out specific
dimensional limitations on potentially injury-threatening gaps
and spaces that can occur between bed system components,
such as rails, when not properly installed. GF Health Products,
Inc. and Basic American Medical Products have conformed
to these guidelines from a manufacturing aspect. However,
entrapment issues can often arise when a healthcare provider /
facility has not correctly assembled the components on a bed.
It is essential that the provider / facility fully understand their
responsibility in complying to the guidelines set forth by the
FDA in order to avoid injury. To that end, we have provided
the FDA's web address at right as a resource for understanding
and following these guidelines for the safety of patients /
residents.
GF Health Products, Inc. - www.grahamfield.com
MATRIX SERIES
It is also essential to have the correct bed components /
accessories that correspond with the needs of the patient /
resident and the particular bed you have purchased. Matching
the correct bed component that correlates with the regulatory
guidelines can be a daunting task. Our sales team at GF
Health Products, Inc. and our friendly Customer Service
Representatives at Basic American Medical Products can help
you sift through the wide array of compliance and bed options.
We will help you determine which bed / bed part is best for the
patient's / resident's particular needs and help you with any
compliance issues.
The MATRIX series bed and accessories listed in these
instructions are in full compliance with FDA guidelines
for reducing the risk of bed entrapment: "Hospital Bed
System Dimensional and Assessment Guidance to Reduce
Entrapment".
Details can be found at www.fda.gov.
Matrix Series Instructions for Use 999.0908-190C
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