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developing hospital/convalescent beds; recommends specific test methods to assess the conformance of existing
hospital/convalescent bed systems; and answers frequently-asked questions about entrapment issues.
The FDA Guidance document identifies specific dimensional criteria on potentially injury-threatening gaps and spaces that
can occur between bed system components, such as side rails when improperly installed.
Please be aware that entrapment issues can still arise when components and accessories are not properly installed on
the bed. It is important for the provider or facility staff to recognize they have an equal role in complying with the FDA
guidelines to help ensure resident safety and avoid injuries.
Copies of this document can be obtained from the FDA website:
http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072662.htm
Summary of Contents for 15003P
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