Assistive technology devices are intended to compensate for or alleviate an injury, handicap or illness; or to replace a physical function.
Examples of assistive technology
- mobility aids (wheelchairs, walking aids, artificial limbs)
- communication and hearing aids
- posture management (from simple cushions to complex support systems)
- pressure management (pressure redistribution/relief cushions and mattresses)
- moving and handling systems (hoists, slings, slider boards, bath lifts)
- hospital and community beds, mattresses and accessories
- therapy equipment
- telecare (personal alarm systems, home care systems etc)
- devices for the alleviation of, or compensation for, a disability or those used during rehabilitation.
Not all items used in healthcare establishments are classified as medical devices as defined in the Medical Devices Directives. Some aids for daily living are not a medical device as defined in the Medical Device Regulations. For example, a bath with a door is not likely to be a medical device but a bath with an integral user lifting mechanism (e.g. a hoist or a chair that swings the user in and out of the bath as well as raising and lowering) is a medical device. Responsibility for investigating incidents involving this type of equipment lies with local trading standards bodies. Our advice is that you should contact your local trading standards office directly. You can find your local office using the locator on this website - http://www.tradingstandards.gov.uk/advice/index.cfm (external link).
The issue of what is and what is not a medical device has been discussed at European Union level and there is published guidance covering 'aids for daily living' - see MEDDEV 2.1/1 'Definitions of 'medical devices', 'accessory' and 'manufacturer' (external link) section 1.1 e)
Specifically, this MEDDEV guidance states that, in the case of equipment intended for compensation or alleviation of a handicap, there must be a direct link between the corrective function of the product and the individual using the product. It includes the example of toilet equipment for the disabled as not being medical devices. Furthermore, neither bath or shower chairs / stools nor commodes are regarded as medical devices for the same reasons: (a) there is no direct link between them and the user in terms of compensation for an injury or handicap and (b) the primary purpose is a toiletry one.
The MHRA publication Guidance Note 20 covers general 'borderline' device issues.
Adverse incidents
Problems with a device may arise from situations such as:
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shortcomings in the device itself
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inadequate instructions for use from the manufacturer
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inadequate repair or maintenance instructions from the manufacturer
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poor, or lack of, training in how to use the device
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poor, or lack of, training in how to repair or maintain the device
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inappropriate local modifications/adjustments
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inadequate maintenance process
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inadequate/inappropriate repairs/replacement parts
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problems from storage/use conditions
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inadequate end of life/scrapping information from the manufacturer or provider
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incompatibility or the lack of compatibility information with other devices
Please report all adverse incidents to us. The best way to report is via our online devices reporting pages. These also give email and fax alternatives for reports.
Guidance documents
From the MHRA
Safe use of bed rails poster - August 2011
Assistive technologies special issue One Liner - November 2011
Wheelchair safety One Liner - October 2011
Walking aids special One Liner - June 2008
Hoists and slings One Liner - October 2007
Assistive technologies special One Liner - February 2007
Guidance on the safe use of bed rails - December 2006
From other organisations
Department for Transport: 'Mobility scooters and powered wheelchairs on the road - some guidance for users' March 2012 (external link)
If you have a query, you can contact us on telephone number 020 3080 6000 or by email on dts@mhra.gsi.gov.uk
