Joined in 2023 
82 
63 About this deal
A pressure ulcer reduction overlay was added to a bed that already had a bed rail fitted. The additional height of the combined mattress/overlay reduced the height of the bed rail. The bed occupant fell over the rail, sustaining a serious head injury. For more information on gaps permitted by device standards, please see Appendix 2 – Bed rail dimensions in BS EN 60601-2-52 and Appendix 3 – Bed rail dimensions in BS EN 50637. Note that the values expressed in standards are primarily intended for the manufacturers of medical devices. Selection An adverse incident is an event that causes, or has the potential to cause, unexpected or unwanted effects involving the safety of device users (including patients) or other persons. Adverse incidents can be caused by: From our investigations, the MHRA has identified a number of potential risk[[JJ7]] areas that, if they had been avoided during the selection process, may have reduced the likelihood of adverse incidents occurring. For example, avoid:
If a manufacturer wishes to market a medical device, the device must bear a mark: currently in Great Britain this can either be a UKCA mark or a CE mark, and in Northern Ireland this is a CE mark. A device may only bear these marks if the manufacturer fulfils certain obligations (conformity assessment). Other openings defined by accessories (e.g. IV poles, fracture frames) and side rails, head or foot boards and or mattress support platform. Not shown in figures.Plastic components that can degrade due to factors such as ageing, exposure to light and some cleaning chemicals. BS EN 50637:2017 “Medical electrical equipment. Particular requirements for the basic safety and essential performance of medical beds for children”
Paragraph added to the summary section which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.Use of bed rails in the community comes with additional challenges. There may be greater variability in available equipment, and it can be more difficult to maintain equipment appropriately than in hospitals. Those responsible for day to day care may be less aware of the serious risk that can be present with improper use of bed rails. Any subsequent changes in the bed occupant’s health and wellbeing (such as cognitive decline, deterioration in eyesight or weight changes) could increase the risk of inappropriate bed rail use. Unlike most other inflatable bed bumpers that use only non-skid grip strips to keep them in place, the hiccapop inflatable bed rails feature silicon-bottom safety flap extensions that use your child’s weight to keep them anchored in place! This robust non-slip design allows for the most restful and safe sleep for even the most active sleepers. BS EN 60601-2-52: 2010+A1:2015 “Particular requirements for the basic safety and essential performance of medical beds”. If you are member of the public and live in England, Scotland, Wales, or Northern Ireland you should report adverse incidents via the MHRA Yellow Card scheme.
To thoroughly inspect these areas, it may be necessary to remove duvets, blankets, sheets, and valances. Bed rails must 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) footnote 3, in combination with, or as an accessory to, the bed if their intended use meets the definition of a medical device. Manufacturers may opt to demonstrate compliance with aspects of the UK Medical Devices Regulations 2002 by making sure their products meet designated standards. When purchasing or specifying equipment, it may be desirable to confirm what technical standards are met by the device. This should be available either in the device instructions for use or from the manufacturer themselves.Entrapment can also occur in the space between a poorly fitting mattress and side of the bed rail or bed rail that does not fit the bed base snugly enough. Again, pillows and rolled up blankets can work, but they can get easily get flattened and move around, making them less reliable and safe for your child. Inflatable bed rails have grip strips to keep them in place. The hiccapop inflatable bed rail even has a silicon-bottom safety flap extension that uses body weight to keep it in place. And because they are inflatable, the bed rails should keep their size and shape all night. 5. Keep Toddlers in the Bed The possible combinations of bed rails, beds and mattresses (and other equipment in the environment), together with the individual needs of the bed occupant, means that a robust and person-centred risk assessment of the equipment, environment and the person is necessary to avoid serious incidents.
MHRA adverse incident investigations have confirmed that some incidents with bed rails have been caused by inadequate maintenance. Bed rails should be included in planned preventative maintenance schemes.alarm systems to alert carers that a person has moved from their normal position or wants to get out of bed
Great Deal 
New Comment