§ Tim LoughtonTo ask the Secretary of State for Health what guidance he has issued to(a) NHS trusts and (b) social services departments on the expected safe lifetime of electric wheelchairs. [178497]
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§ Dr. LadymanThe Medicines and Healthcare products Regulatory Agency (MHRA) has specific responsibility on behalf of the Secretary of State to safeguard public health where medical devices are involved. Electric powered wheelchairs come within this overall remit.
MHRA has issued guidance, which is available to health and social services. This guidance relates to the management, purchase, repair and maintenance of medical devices. This guidance has also been incorporated into the NHS Controls assurance Standards for medical devices.
The wheelchair manufacturer should provide information on the expected safe lifetime of his product. This is dependent on the use, repair and maintenance being carried out in line with the manufacturer's instructions.
Many manufacturers base their lifetime information on the results that they obtain from the international standards for impact and fatigue testing of wheelchairs during their product development. This standard is generally taken to equate to approximately five years of moderate use of an occupied wheelchair.
Infrequent light usage of a wheelchair combined with appropriate maintenance may allow the lifetime to be extended. A lower quality wheelchair and inappropriate or heavy usage combined with inadequate maintenance will shorten the expected safe lifetime of the wheelchair.
§ Tim LoughtonTo ask the Secretary of State for Health what guidance he has issued to(a) NHS trusts and (b) social services departments about the use of reconditioned motors in electric wheelchairs. [178498]
§ Dr. LadymanThe Medicines and Healthcare products Regulatory Agency (MHRA) has specific responsibility on behalf of the Secretary of State to safeguard public health where medical devices are involved. Electric powered wheelchairs come within this overall remit.
MHRA has issued guidance, which is available to, health and social services. This guidance relates to the management, repair and maintenance of medical devices. This guidance has also been incorporated into the NHS Controls Assurance Standards for medical devices.
Within this guidance the use of reconditioned parts such as motors for electric wheelchairs is acknowledged as an option that can be cost effective. However, the source and specification of the reconditioning process is a critical element. It is generally recommended that reconditioning is carried out by the original equipment manufacturer. If it is to be carried out by another source then it is essential that the reconditioner can prove that the process has produced the same level of safety, technical specification and performance as the original equipment. The fitting of the reconditioned motor and 1132W any subsequent changes that are required to the maintenance process for the wheelchair itself will also need to be recorded in the equipment records for the wheelchairs.