They may be UKCA, CE or CE UKNI marked as medical devices to show they meet the requirements of the UK Medical Devices Regulations 2002 (as amended) (2), in combination with, or as an accessory to, the bed if their intended use meets the definition of a medical device. They are not designed or intended to limit the freedom of people by preventing them from intentionally leaving their beds nor are they intended to restrain people whose condition disposes them to erratic, repetitive or violent movement. In general, manufacturers intend their bed rails to be used to prevent or reduce the risk of bed occupants from falling and sustaining injury. bed side rails, side rails, cot sides, and safety sides. Bed Railsįor the purpose of this document the term bed rail will be adopted, although other names are often used, e.g. NHS ‘Never events’ number 11 (1) covers chest or neck entrapment in bed rails. NHS ‘Never events’ are defined as ‘serious, largely preventable patient safety incidents that should not occur if the available preventative measures have been implemented by healthcare providers. Clinicians should carefully consider the benefits and risks of bed rails before they are used for an individual bed user. These could have been prevented if adequate risk assessments and appropriate risk management had been carried out. Most incidents occurred in community care settings, particularly in nursing homes. The most serious of these have led to injury and death by asphyxiation after entrapment of the head, neck or chest. However, the MHRA continues to receive reports of adverse incidents involving these devices. Introductionīed rails are used extensively in acute, community and home care environments to reduce the risk of bed occupants falling out of bed and injuring themselves. This document is not intended to replace clinical decision making.
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