§ Mr. BoswellTo ask the Secretary of State for Health how many adverse incidents involving(a) electrically powered and (b) manual wheelchairs have been reported to the Medical Devices Agency in each of the past three years; and what steps he is taking to improve (i) the comprehensiveness of such reports and (ii) their utility in identifying and remedying systematic faults. [48818]
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§ Ms Blears[holding answer 17 April 2002]: The Medical Devices Agency (MDA) has a specific section that deals with adverse incident reports relating to all wheeled mobility equipment. The numbers of reports received by MDA held on their database relating specifically to manual and powered wheelchairs are as follows:
Year Manual Powered 2001 641 471 2000 624 466 1999 598 374 A specific detailed form has been compiled and is widely available to assist reporters in providing sufficient detail on each adverse incident. The format and layout is regularly reviewed to ensure that changes are made when appropriate. The form is available from the MDA web site.
MDA issue guidance at the beginning of each year on the incident reporting system to provide details on how to report an incident, what other action to take and what action MDA may take following up on the report. The content is reviewed each year to allow updates to be made where necessary. In addition, MDA meet regularly with professional, service, user groups and manufacturers and periodically use these meetings to promote the need for reporting incidents and emphasising the need to provide comprehensive information on the product, its service and usage history as well as details of the incident itself.
To assist in identifying trends of problems with specific equipment, root cause analysis is used on all reports on the MDA database. Any trends found are then investigated and corrective action initiated where necessary.