Entrapment & Compliance Information - Basic American Zenith 7000 Instructions For Use And Service Manual

ENTRAPMENT & COMPLIANCE INFORMATION
On March 10, 2006, the FDA (U.S. Food and Drug Adminis-
tration) 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/conva-
lescent 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. Graham-Field's Long-Term Care Bed
division: Basic American Medical Products, is an HBSW charter
member. As a result of Graham-Field's commitment to product
safety, all of Graham-Field's current long-term care beds have
been strictly tested and conform to the new FDA Guidance.
The guidelines set forth by the FDA Guidance layout specific
dimensional limitations on potentially injury-threatening gaps
and spaces that can occur between bed system components,
such as rails, when not properly installed. Graham-Field 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 links below as
a resource for understanding and following these guidelines for
the safety of the patient/resident.
Basic American Medical Products, a division of GF Health Products, Inc.
Graham-Field encourages all hospital bed own-
ers to read the FDA guidance.
◗ Please visit the FDA's Hospital Bed Safety page at . . .
"http://www.fda.gov/cdrh/beds/"
◗ To find many resources, including a link to the new Guidance
page go to "http://www.fda.gov/cdrh/beds/guidance/1537.pdf"
◗ Ordering instructions for a Testing Kit which you can use
to determine whether your beds are in conformance with the
guidance can be found at . . .
"http://www.fda.gov/cdrh/beds/entrapmentkit.html"("http://
www.fda.gov/cdrh/beds/entrapmentkit.html"
http://www.fda.gov/cdrh/beds/entrapmentkit.html);
◗ A discussion of Clinical Guidance protocol which you can use
to assess an individual patient's needs when using a side rail can
be found at . . .
"http://www.ute.kendal.org/learning/documents/clinicalguidance_Side
Rails.pdf"
These resources will supply you with the knowledge to evaluate
the safety of the hospital beds you currently own.
It is also essential to have the correct bed components/acces-
sories that correspond with the needs of your 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 Graham-Field Sales team and the 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 your patient's/resident's particular needs and help you
with your compliance issues.
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ZENITH SERIES
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