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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 (AT) medical devices are intended to compensate for or alleviate an injury, disability or illness or to replace a physical function. There should be a direct link between the corrective function of the product and the individual using the product for it to be medical device.
2. AT products as medical devices
2.1 Examples of AT medical devices are:
- mobility aids:
- wheelchairs and scooters
- walking aids (including crutches, walking sticks and frames)
- 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 (exercise bands)
Most of AT devices are class I or custom made medical devices. They may also be manufactured in-house by healthcare establishments rather than bought from manufacturers.
2.3 Aids for daily living
Some AT 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, most bath and shower chairs, stools and commodes are not regarded as medical devices because: * there is no direct link between them and the user in terms of compensation for an injury or disability * the primary purpose is personal hygiene, rather than medical or mobility
If you have a problem with such a product, please contact your local Trading Standards Office.
The Office for Product Safety and Standards provides information on consumer recalls.
3. Safety issues
3.1 What can go wrong
Problems with an assistive technology device may include:
- inadequate repair or maintenance instructions from the manufacturer
- poor or lack of training in how to use/repair/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
- Problems with the device itself:
- failure of the device, e.g. cracks, leaks, detachments
- Device documentation (e.g. instructions for use, technical/operation manual etc.):
- not complete
- not with the device
- Non-CE marked devices that are supplied to the UK
- Aids for daily living that are marked as medical devices in the UK
3.2 What to do with a failed device
If you are a personal user:
- do not use the device if you are worried about its safety, for example if it doesn’t feel safe to use as described in the instructions.
- contact your healthcare professional if you were given the device by them or if not, contact the retailer or manufacturer.
If you are a professional user:
- quarantine the device
- contact the manufacturer and request them to collect and analyse the device.
3.3 What to do next
All problems/adverse incidents with a medical device should be reported to MHRA
MHRA reviews all incident reports. The more incidents received, the more likely it is that appropriate corrective actions are taken by the manufacturer to improve safety. Sometimes, a single report can lead to corrective action.
3.4 What happens to your report
- given an investigation grading and added to our database.
Reports are actively investigated when:
- they are reports of death or serious injury
- the manufacturer’s investigation indicates a wider problem
- MHRA detects a pattern in reported problems This is called signal detection.
MHRA investigate reports based on their risk, so that resources can be focused on high-risk safety issues.
MHRA will always:
- tell you, within 10 working days of receipt of your report, what we plan to do
- send your report to the manufacturer for their internal investigation. Your details are only supplied if you have agreed to this on your report.
- request the manufacturer to review
- and if they investigate then provide details of their findings
- review the manufacturer’s findings.
When the manufacturer carries out an internal investigation, please provide them with any details they request.
3.5 Why you should report
- fulfill your duty of candour (if you are a healthcare professional),
- first identify a device issue of national significance, or to help to trigger a cascade of corrective actions,
- help form a full picture of issues experienced in the UK,
- improve quality of clinical/care services to users,
- prevent serious harm to others.
Examples of actions taken from reported incidents
A report of a drive wheel detaching from a powered wheelchair whilst in use resulting chair tilting to one side:
- key things were missed from the technical manual
- a Field Safety Notice (FSN) and a Medical Device Alert (MDA) were issued.
An emerging trend in handle fractures of a walking stick was identified by MHRA:
- an FSN was issued to remove and destroy affected devices from use
- changes in the device production and a new testing routine were implemented.
A report of patient death from falling out of a sling during transfer from a bed due to a clip disconnection:
- an FSN was issued to remind users of the importance of doing a risk assessment before using the sling for the first time and carrying out pre-use checks
- Instructions for Use (IFU) were updated
- an MDA was issued.
4. Further guidance
4.1 From MHRA
Enquiries: contact MHRA
4.2 From other organisations
Department for Transport: mobility scooters and powered wheelchairs on the road - some guidance for users
Posture and Mobility Group: transportation of people seated in wheelchairs
British Health Care Trades Association: Get wise leaflets