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Tri-Flex II™ Bariatric Bed |
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Tri-Flex II
Surface Width
Panel Extends
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DO YOUR HOSPTIAL BEDS MEET THE FEDERAL REGULATIONS?
FEDERAL REGULATIONS REQUIRE INDEPENDENT
TESTING/LISTING TO THE IEC60601-2-38 FOR
ELECTRIC HOSPITAL BEDS
Many hospital administrators are unaware that all beds in their facility, including bariatric beds should
meet the IEC 60601-2-38(2-38) U.S. electric hospital bed standard. The 2-38 is the first and only standard ever
developed to specifically test the safety and effectiveness of electric hospital beds. The Occupational Safety and
Health Administration (OSHA) requires that any new hospital bed used in a hospital, nursing home or any public
facility be tested to meet the 2-38 standard by a nationally recognized testing laboratory (NRTL), such as UL,
ETL or CSA. The NRTL 2-38 standard certification mark must be placed on the bed. For many years, the Food
and Drug Administration has used the 2-38 as the recognized consensus standard for testing all electric hospital
beds, defining the minimum allowable construction and performance requirements.
A bed’s failure to meet the 2-38 standard raises questions of patient and staff safety as well as creating
additional issues of product liability for the facility. Some bed manufacturers are currently claiming listings to
invalid standards that are unacceptable to use in place of the 2-38. One current practice is placing a confusing UL
label on the bed without listing the standard to which it was tested.
Any incident involving a non 2-38 NRTL tested bed puts your facility at greater liability risk. The following
numbers demonstrate some of the incidents facilities are currently encountering. The FDA’s website reports 116
deaths by side rail entrapment, 12 bed fire incidents and 8 possible deaths by fire since 2002. In addition, there
have been multiple bed recalls including one recall of over 200,000 beds for potential fires. The vast majority of
these incidents involve beds that were not tested to the 2-38 standard. Protect your facility by requesting a certification letter issued by the NRTL, for any new bariatric bed rented or purchased for your facility. The letter should
specifically state that the bed was tested and meets the IEC 60601-2-38 U.S. electric hospital bed standard.
Burke, Inc. has been specializing in bariatric bed frames since 1979.
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