Basic American Medical Products, a division of GF Health Products, Inc. www.grahamfield.com 999-0831-190A Service Manual
7
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. 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 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. 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.
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 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 your patient’s/resident’s particular
needs and help you with your compliance issues.

the APs 9000 bed and accessories listed in this

manual 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 found at www.fda.gov.

Zenith aps seRies
ENTRAPMENT & COMPLIANCE INFORMATION