The Care Quality Commission has ‘Learning from safety incidents’ resources specifically related to bed rails. Each one briefly describes a critical issue - what happened, what CQC and the provider have done about it, and the steps you can take to avoid it happening in your service. The Management of Health and Safety at Work Regulations 1999 The MHRA is the regulator of medicines, medical devices and blood components for transfusion in the UK, a role which includes overseeing investigations into adverse events and promoting the safe use of devices in the UK.

intact labelling and if the instructions for use have been updated, the updated version should be provided to the bed occupant and/or their carers We suggest manufacturer’s instructions for use contain information on the selection of the mattress, including dimensions and other characteristics, to reduce the risk of entrapment. They should also contain information on compatibility with other equipment and whether they are suitable for children or small adults. It should be ensured that the bed, mattress and bed rails in combination are compatible and do not have gaps not permitted by device standards, which could lead to entrapment.Plastic components that can degrade due to factors such as ageing, exposure to light and some cleaning chemicals. The decision to use bed rails should be made with the person’s consent, wherever possible, remembering that they may have a different perception of risk to the prescriber and therefore disagree on whether the risks are acceptable or not. The reasoning for the decision to prescribe bed rails should be effectively communicated and recorded, including to the carers or family members when this is appropriate. Use of bed rails in these ways can increase the risk of falling. In some cases, the patient may attempt to climb over the bed rail, leading to the potential to fall from a height. Erratic, repetitive or violent movements may also cause the bed rails to break, leading to an increased risk of falling or injury from the broken rail. the reduction in the effective height of the bed rail relative to the top of the mattress may allow the occupant to roll over the top of it; extra height bed rails may be required

From 1 January 2018 to 31 December 2022, we received 18 reports of deaths related to bed rails and associated equipment, and 54 reports of serious injuries. Use the rails as instructed by the bed manufacturer. The bed rails must be UKCA, CE or CE UKNI marked to show they meet the requirements of the Medical Devices Regulations 2002 footnote 3 or EU Medical Devices Regulation 2017/207 in combination with, or as an accessory to, the bed. Bariatric beds A child slipped feet first between the bed rail and the bed. The gap was not large enough for the child to pass completely through and the child was trapped at chest level and died from postural asphyxiation.

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Integral type bed rails have been involved in far fewer adverse incidents than third-party types. Usually this is because risks associated with installation and compatibility are reduced, as correct gaps are designed into the bed. Bed rails should meet recognised product standards that include acceptable gaps and dimensions when fitted to the bed (See Legislation and Standards). This document identifies areas for safe practices, so that policies and procedures can be reviewed and put in place. This includes: All care professionals should understand their obligations under this legislation, and organisations should ensure that these requirements can be implemented effectively. Standards 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: using unsecure fittings or designs which permit the bed rail to move away from the side of the bed or mattress, creating an entrapment hazard

the risk of entrapment in the vertical gap between the side of the mattress and the bed rail may be increased with an easily compressible overlay and/or mattress edge disseminate advice to the healthcare professions to prevent adverse incidents and promote good practice for use and maintenance of devices. 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. Some questions to consider during a risk assessment to determine if the overall risks of using bed rails outweigh the possible benefits include: In general, manufacturers intend their bed rails to be used to prevent or reduce the risk of bed occupants falling and sustaining injury. They are not designed or intended to limit the freedom of people by preventing them from intentionally leaving their beds. In addition, they are not intended to restrain people whose condition disposes them to erratic, repetitive or violent movement.

The government has extended acceptance of CE marked devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime. Who this guidance is for: The majority of bed rails on the market are designed to be used only with individuals over 1.46 m in height (4 foot 9 inches), which is also the height of an average 12-year-old child. A risk assessment should always be carried out on the suitability of the bed rail for the individual child or adult with atypical anatomy, as bar spacing and other gaps will need to be reduced. The need for risk assessments to be updated regularly. The frequency of reviewing the risk assessment will vary depending on the patient and their circumstances and should be recorded as part of the risk assessment, but will likely be more frequent for children.

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. is there an inappropriate gap between the lower bar of the bed rail and the top of the mattress or does the mattress compress easily at its edge which could cause entrapment? At 48 inches long, 7 inches wide and 5 inches tall, whether your child is sleeping in a twin bed, a queen-sized, or a king bed, you can rest assured knowing they are safe and sound when using these portable bed rails. Most adjustable and profiling beds feature integral bed rails that are incorporated into the bed design or are offered as an optional accessory by the bed manufacturer. We have found they are involved in far fewer adverse incidents than the third-party type. However, they can involve some hazards so should be used with caution too.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). While not perfect, the above alternatives to bringing inflatable bed rails for toddlers on your family trip will work in a pinch! Our Preferred Option for Toddler Travel Sleeping if the standard mattress is replaced with an air mattress or lightweight foam mattress, third party bed rail assemblies (including the mattress and bed occupant) can tip off the bed when the bed occupant rolls against the bed rail. This is because many third-party bed rails rely on the weight of a standard mattress to hold the assembly in place That’s mainly what makes inflatable bed rails for toddlers one of the most practical toddler travel essentials. using bed rails designed for a divan bed on a wooden or metal bedstead, this can create gaps which may entrap the occupant