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The Parliamentary Under-Secretary of State for Health (Dr. Stephen Ladyman): I am grateful to the hon. Member for Colchester (Bob Russell) for raising the topic of the safety of powered wheelchairs and scooters. The Government take the safety of those products as seriously as he does and I am glad to have the opportunity to debate the matter this evening.
It is not often at the start of an Adjournment debate that I, as a mere Under-Secretary, can say something that ought to satisfy the Member initiating the debate 100 per cent., but I am going to take the chance tonight. I am the Minister for wheelchairs. Until the Prime Minister tells me differently, I lead on wheelchairs.
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Of course, in so far as wheelchairs are classed as vehicles and therefore go on the highways, my ministerial colleagues in the Department for Transport will have some very serious involvement in these matters, and I will defer to them and always take their guidance on certain issues. But if the hon. Gentleman or his constituents ever wish to know which Government Department and which Minister is leading on this matter, it is the Department of Health and me.
Before I respond to the main issues raised, I will provide some background to the relevant legislation and explain why I am fairly confident in saying that this is primarily a matter for the Department of Health, with the interest of the Department for Transport duly noted.
Non-powered and powered wheelchairs, including scooters, are generally regarded as class 1 medical devices. As such, they are covered in England by the Medical Devices (Amendment) Regulations 2003, SI 2003 No. 1697. I am sure that the hon. Gentleman will want to obtain that document straight after the debate. It amended the earlier 2002 regulations, so when he is in the Library, he will also need to acquire, if he wants to obtain the full picture, SI 2002 No. 618. Those regulations include essential requirements covering the risk management, design, production, labelling and user instructions of all devices. He will also want to acquire the European medical devices directive, Council directive 93/42/EEC, as the regulations bring it and its later amendments into UK legislation.
Powered wheelchairs and powered scooters, designed to provide essential independent mobility for disabled people, are also defined—I acknowledge the hon. Gentleman's point that this is where the confusion arises—as "invalid carriages" under the Use of Invalid Carriages on Highways Regulations 1988. If any disabled people watching our proceedings tonight are offended by use of the term "invalid carriages", I apologise—I am sure that the hon. Gentleman would, too—but the term was in general usage back in 1988, so we have to use it when we refer to that legislation.
As the hon. Gentleman said, the 1988 regulations divided these machines into three classes. Class 1 covers manual wheelchairs. Class 2 applies to machines designed for use on the footway, travelling at speeds of up to 4 mph. Incidentally, that is generally regarded as walking pace, albeit reasonably brisk. They may also be used on the road to cross from one footway to another or where no footway is available. Finally, class 3 covers machines that can be used both on the footway—where, like class 2 vehicles, they are limited to 4 mph—and on the road, where they can travel at up to 8 mph. From my experience in my constituency, I wonder whether all my law-abiding constituents, men and women, are limiting their vehicles to 4 mph when they are on the pavement. All classes of those vehicles may be used legally only by one person: it must be a disabled person or someone involved in the sale or maintenance of the vehicle or the training of the user.
Powered wheelchairs and scooters should not be seen as an alternative to a private car. They were introduced to provide local outdoor mobility for disabled people who might otherwise be confined to their home. Indeed, for the purposes of road traffic legislation, these vehicles are defined as
Powered wheelchairs or scooters do not need to meet the same construction standards as a motor vehicle and nor do their users need to meet the same fitness standards as those required of a driver. The level of control has generally been regarded as reasonable, given the speed restrictions and other limitations set in regulations covering their construction and use.
My understanding is that the police have powers to check the speed of these vehicles on the pavement and on the highway, which paints a picture of policemen hiding behind trees with radar guns in order to leap out and catch "hell's grannies" as they perambulate through our constituencies.
The Department for Transport has, as the hon. Gentleman said, recently engaged a research company to carry out a review of the invalid carriage regulations. The review will incorporate input from a wide selection of stakeholders, including the Department of Health and the Medicines and Healthcare products Regulatory Agency, the MHRA. Many of the manufacturers and suppliers are members of the British Healthcare Trades Association, the main trade association for wheelchair manufacturers and distributors. That organisation lays down standards for its members on the quality of products sold and the requirements for the ethical conduct of business.
On behalf of the Secretary of State for Health, the MHRA—an agency of the Department of Health—performs the role of the competent authority for the regulations, ensuring that medical devices placed on the market in England meet all the relevant essential requirements of the regulations. The MHRA has a specialist team based at its wheeled mobility and seating centre in Blackpool, Lancashire, which has specific responsibility to oversee all safety-related issues concerning wheelchairs.
The MHRA has links with all major stakeholders, such as the National Forum of Wheelchair User Groups, the National Wheelchair Managers Forum, the Foundation for Assistive Technology, the NHS Purchasing and Supply Agency, the BHTA, local Trading Standards, the British Standards Institute, the Department for Transport and relevant NHS professional groups and training bodies. The MHRA investigates all reports of safety-related issues, including via its adverse incident reporting system, especially when injury or death has occurred. The reporting system is accessible to users, professional carers, manufacturers and distributors. It received and investigated 1,142 adverse incident reports relating to all types of wheelchairs in 2004. Of those, eight reports involved the fatality of the wheelchair user. As a direct result of the investigations during 2004, manufacturers have updated designs, testing processes and user information for their products.
The MHRA issued a guidance document in 2004 specifically aimed at wheelchair users and two medical device alerts in January 2005 to raise specific action points for all concerned with the provision, prescription, repair and maintenance, and use of wheelchairs, seating and accessories. The guidance and the alerts have been distributed widely both in the NHS and to other interested stakeholders.
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As a result of previous investigations and feedback from stakeholders, the MHRA submitted, via the BSI UK experts group, various recommendations to update the content of the European standards for powered and non-powered wheelchairs. As both of those standards are harmonised to the European medical devices directive, manufacturers throughout Europe use them to show how they have met the essential requirements of the directive and, hence, how they meet the UK regulations.
Recommendations covered improved requirements for braking systems and the contents and format of the user information provided with each wheelchair, in addition to many other detailed improvements. The BSI experts group supported those recommendations, which were submitted to the European standards expert group for consideration. As recently as last week, the European experts group accepted the main recommendations submitted. The amendments will now be included in the revision of both standards, which are due to be issued for final member country vote later this year.
Bob Russell: I welcome the big improvements for new machines for first-time purchasers, but problems often arise in the second-hand market, with the lack of maintenance and insurance, and questions about the competence of drivers.
Dr. Ladyman: The hon. Gentleman raises a valid point and I shall refer to one or two aspects of that in a moment. The second-hand market is a big concern and must be addressed.
The MHRA will continue to provide advice and guidance, and will recommend changes to the relevant standards based on the experience gained from the adverse incident reports received. The number of wheelchair users in England is estimated to be about 1.2 million, of which some 800,000 have been supplied on long-term loan by NHS wheelchair services, which maintains its own prescription and supply systems based on local criteria. The largest age group of wheelchair users is over 65 years old, and is female. That user group is expected to increase in number as life expectancy increases.
In line with Government policy, the long-term health needs of the population will be met by locally based services to allow people to remain independent in their own homes, so there will be an increased need for the provision of personal mobility equipment. All users of powered wheelchairs and scooters should receive adequate training when they are supplied with the equipment, either by the NHS or through the supplier of a private purchase. The NHS always assesses the competence of a user before issuing a powered wheelchair. Private sales, however, do not have any mandatory, structured assessment of competence before
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supply. However, the BHTA recently launched a code of practice for its members, which addressed, among other matters, the provision of adequate training for purchasers of wheelchairs.
The speed restrictions and other limitations set in regulations covering powered wheelchairs are generally regarded as sufficient for class 2 or 4 mph powered wheelchairs, and class 3 or 8 mph wheelchairs. Many of the users may have been, or still are, car drivers and they will have experience of the highway code. To regulate the use of mechanised wheelchairs further would impose unnecessary restrictions on their availability to an increasing section of the population who are dependent on such equipment to provide them with an improved quality of life, when faced with limited mobility due to a disability.
The control of the sale of second-hand mechanised wheelchairs, particularly when sold privately, is not an easy matter on which to legislate—I accept the hon. Gentleman's concerns—but the BHTA's recently introduced code of practice is a welcome sign that the trade associations are taking the issue seriously. Of course that only applies when someone buys second hand from a trader. Obviously, there will be a failure to follow that sort of guidance when someone buys second hand from another private person.
Insurance is not compulsory for powered wheelchairs. The Department of Health recommends that the users of class 3 powered wheelchairs should have third-party insurance. The Department for Transport also issues a code of practice and recommends that users check their domestic policies to find out whether they are covered and, if not, to take out separate cover. Previous consultations on the subject have shown that some disability groups opposed compulsory insurance, but the Department for Transport is seeking views on that issue as part of its review of the 1988 regulations.
The MHRA continues to raise the need for regular maintenance by NHS wheelchair services and has recently issued a medical device alert that includes recommended action points to stress that adequate maintenance, in line with the manufacturers' instructions, is essential for all wheelchairs. Members of the BHTA also try to ensure that the purchasers of all wheelchairs are aware of the need to carry out regular maintenance of those products, in line with the manufacturers' instructions.
To conclude, these wheelchairs are important tools that help people to maintain their independence, but we need to work hard to ensure that they are safe and safely used. I encourage anyone interested in this issue to make their views known to the Department for Transport while the review of regulations is under way, and I will ensure that the official record of this debate is brought to the attention of those who are conducting the review.
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