§ Ann ClwydTo ask the Secretary of State for Health if he will make a statement about the Adverse Incident Centre. [23012]
§ Ms JowellThe Adverse Incident Centre is managed by the Medical Devices Agency. It is the first point of contact for reporting adverse incidents involving medical devices used in the National Health Service.
All reports are analysed and those involving death or serious injury, or with the potential to cause it, are investigated fully. Where appropriate, the agency issues a Hazard or Safety Notice to the NHS advising of hazardous products or unsafe procedures and the actions that should be taken.
In many other cases, the manufacturer is asked to investigate the incident. The agency reviews the manufacturer's response and, where appropriate, notifies the reporter of the outcome.
The agency publishes an annual survey of reported incidents as part of its efforts to increase awareness of the importance of reporting them.
The Adverse Incident Centre database holds over 32,000 incident records, dating back to 1987. Over 5300 adverse incident reports were received in 1997.