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This publication is available at https://www.gov.uk/government/publications/assistive-technology-definition-and-safe-use/assistive-technology-definition-and-safe-use
Assistive technology devices are intended to compensate for or alleviate an injury, handicap or illness or to replace a physical function. For example:
- mobility aids
- 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
- slider boards
- bath lifts
- hospital and community beds, mattresses and accessories
- therapy equipment
- telecare (personal alarm systems, home care systems etc)
The European Commission guidance says that to be a medical device, equipment which compensates for or alleviates a handicap must have a direct link between the corrective function of the product and the individual using the product.
Some assistive technology products are aids for daily living. These help people carry out day-to-day activities, but are not classified as medical devices as defined in the Medical Devices Regulations.
For example bath and shower chairs, and stools and commodes are not regarded as medical devices as:
- there is no direct link between them and the user in terms of compensation for an injury or handicap
- the primary purpose is personal hygiene, than medical or mobility
2. Safety issues
Problems with an assistive technology device may include:
- shortcomings in the device itself
- inadequate instructions for use from the manufacturer
- inadequate repair or maintenance instructions from the manufacturer
- poor or lack of training in how to use the device
- poor or lack of training in how to repair or maintain the device
- inappropriate local modifications/adjustments
- inadequate maintenance process
- inadequate or inappropriate repairs/replacement parts
- problems from storage/use conditions
- inadequate end-of-life/scrapping information from the manufacturer or provider
- incompatibility or the lack of compatibility information with other devices
All adverse incidents with a medical device should be reported to MHRA.
3. Further guidance
3.1 From MHRA
3.2 From other organisations
Department for Transport: mobility scooters and powered wheelchairs on the road - some guidance for users