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Guidance Issuing OfficeCenter for Devices and Radiological Health
This guidance provides recommendations relating to hospital beds and hospital bed accessories. The guidance provides recommendations intended to reduce life-threatening entrapments associated with hospital bed systems. It characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, and recommends dimensional criteria for these devices.
Manufacturers may use this guidance when designing new beds to help ensure compliance with applicable FDA regulations such as the Quality System regulation, to provide adequate labeling and instructions for use, and to assist in ensuring that their devices are safe when used as labeled. FDA encourages manufacturers to provide information to medical device distributors, clinicians, patients and families regarding mattress dimensions, compatible components, and issues of entrapment. In addition, the recommendations in this guidance may be useful in evaluating and reducing the entrapment risk presented by hospital beds that have been placed into use, also known as legacy beds.
Not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment. We suggest that facilities and manufacturers determine the level of risk for entrapment and take steps to mitigate the risk. Evaluating the dimensional limits of the gaps in hospital beds is one component of an overall assessment and mitigation strategy to reduce entrapment. As a result, healthcare facilities may use this guidance as part of a bed safety program to help identify entrapment risks that may exist with current hospital bed systems. Other educational documents are available to assist health care facilities in making decisions towards the goal of achieving a safe and comfortable sleeping environment for their patients.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2004-D-0499.