Assistive Technology

The aim of the CAT in Blackpool is to take all reasonable steps to protect the public health and safeguard the interests of users by ensuring that all assistive technology equipment meets appropriate standards of safety, quality and performance and that they comply with the relevant Directives of the European Union.

Examples of assistive technology include:

• Mobility aids (wheelchairs, powered scooters, walking aids, artificial limbs)
• environmental controls (telecare/alarms, remote control of doors, windows and other common household tasks)
• communication and hearing aids
• posture management (from simple cushions to complex support systems and beds)
• pressure management (pressure redistribution/relief, cushions and mattresses)
• moving and handling systems (hoists, slider boards, bath lifts, stair lifts)
• aids for daily living (riser/recliner chairs, commodes, bath aids)

The staff are based in the Centre in Blackpool and also in MHRA Headquarters at Market Towers London. The Centre in Blackpool is a modern, purpose-built, self-contained unit in its own grounds, with good facilities for the disabled and the present team of staff. The centre incorporates a test laboratory for wheelchairs which operates under a quality management system accredited by UKAS against ISO 17025. The test laboratory is used to support adverse incident investigations and also carries out the testing of wheeled mobility equipment in line with draft or published Standards on a chargeable basis for industry.

The 3 main areas of involvement are:

• Investigating adverse incidents and vigilance cases arising from the use of assistive technology and ensuring appropriate action is taken to remove/reduce risks to users and others.
• Providing support to the MHRA Regulatory Compliance Unit.
• Providing safety warnings, technical advice and testing facilities to a wide range of stakeholders.

Adverse incidents
Problems (or the potential for problems) concerning assistive technology should lead to a report being sent to MHRA in line with Medical Device Alert  MDA/2008/001. Problems may arise from:

• shortcomings in the device itself
• inadequate use instructions from the manufacturer
• inadequate repair or maintenance instructions from manufacturer
• poor, or lack of training in use or repair or maintenance
• inappropriate local modifications/adjustments
• inadequate maintenance process
• inadequate/inappropriate repairs/replacement parts
• problems from storage/use conditions
• inadequate end of life/scrapping information from the manufacturer
• inadequate end of life/scrapping policies by equipment providers
• incompatibility or the lack of compatibility information with other devices

All adverse incident reports received concerning AT from users/carers, healthcare professionals, manufacturers or others are initially registered in the Adverse Incident Centre database at MHRA London. They are then transferred electronically for consideration by the medical device specialists working either in Blackpool or London 

'Simple' quality problems and reports which cover a low risk of injury to users, carers or others are normally registered in the database for information and are regularly checked by a specialist to see if these "lower" risk problems highlight any trends which may reveal a more serious underlying situation which requires further investigation. 

The vast majority of reports are not so "simple" and require more information about the initial problem and the level of risk to allow a specialist to decide which way to proceed. Once this extra information is received, a full risk assessment can be carried out. Based on the results of the risk assessment, there may be no further investigation for some, but those remaining are investigated by AT staff in Blackpool or London, or by the manufacturer on our behalf. Any necessary recalls or changes to design, usage instructions, training processes etc are then made by the manufacturers under the supervision of an MHRA specialist to ensure that the problem is resolved and the risk reduced or removed. Regular updates on progress and any findings are always passed back to the originator of the report to ensure that they are kept up to date and also to give them the opportunity to comment on the manufacturer’s actions, or to request further clarification or action where they think it is necessary.

When there is a clear need to inform users and service providers about a potential problem and any necessary remedial action and where the equipment user cannot be adequately traced by the manufacturer, a  Medical Device Alert is issued. For more general issues, MHRA guidance may be issued (see later section Technical Advice).

Medical Devices Regulations Compliance
The Medical Devices Regulations came fully into force on 14 June 1998 and have been updated since first issue. As the Competent Authority one of MHRA's principle objectives is to ensure that all medical devices sold in the UK meet the Essential Requirements laid down in the Regulations so that the health and safety of patients, users and, where appropriate, any other persons is not compromised. Staff investigate any problems raised and liaise with the MHRA Compliance section, where appropriate. The outcome of investigations are also passed on to other Competent Authorities throughout Europe where appropriate.

Manufacturers can also discuss new designs with the specialist staff before equipment is finalised for production. Staff are willing to, and do, give general guidance on questions arising from the Regulations and about the development and testing of new products based on their considerable experience and knowledge. This may include suggesting tests for prototypes or pre production samples (see testing facilities below)

Technical Advice
AT staff frequently receive direct requests for advice from a wide variety of sources. Requests from users, carers, NHS, government departments, PASA, healthcare staff and manufacturers are usually answered direct. If a subject appears to require more in depth written advice for a wider audience (eg when a specific trend towards a problem or potential problem area is highlighted), a Guidance Document or Medical Device Alert may be raised. Simpler problems may be included in an issue of “one liners”. A Guidance Bulletin Guidance on the Stability of Wheelchairs, DB 2004(02) was published in March 2004. Also a Guidance Bulletin on the safe and effective use of batteries and chargers for medical devices, DB2005(03) was published in October 05. Specific one liners for AT devices were also issued in February 07, October 07 and June 08.

The above links will take you direct to the documents on the MHRA website or alternatively all current Medical Device Alerts and these guidance documents are available from the website at www.mhra.gov.uk.

The AT unit is represented on all the major national service interest groups, including the Electronic Assistive Technology (EAT) Group, Prosthetics and orthotics Interest Group (POIG), National Wheelchair Managers Forum (NWMF), Rehabilitation Engineering Service Managers Group, RESMaG, etc, and has links with Empower (national consortium of user groups and charities in the field of Assistive Technology) and other individual user groups. Staff are also members of the Posture and Mobility Group, the Tissue Viability Society and the Institute of Physics and Engineering in Medicine, the Institute of Mechanical Engineers and the Institute of Engineering and Technology.

Testing Facilities
To give confidence in the quality of the laboratory’s testing and also in the technical and commercial integrity of the laboratory’s operations the laboratory is accredited to ISO 17025 by the United Kingdom Accreditation Service (UKAS), the official UK National Authority in the field of laboratory accreditation.

The tests and subsequent certificates are chargeable at cost to the manufacturer. For these, commercial confidentiality is observed and reports are only provided to the manufacturer themselves.

In cases where there is a potential safety problem, the results of testing may possibly be made known to others via a Device Alert or Vigilance Procedures if users in the field could be affected and the manufacturer cannot easily rectify the problem for all users.

ALAN LYNCH
Head of Assistive Technology