§ Mr. BurstowTo ask the Secretary of State for Health how many(a) fatal accidents and (b) adverse incident 195W reports to the Medical Devices Agency there were in each year since 1997; and if he will make a statement on the most common causes of these incidents. [163505]
§ Ms Rosie WintertonThe information on total numbers of reported medical device related adverse incidents and reported incidents involving a fatality is shown in table 1.
Table 1: Reported medical device related adverse incidents 1997–2003
Total number of reported incidents
Reported incidents involving a fatality
1997 5,383 47 1998 6,298 79 1999 6,610 87 2000 7,249 92 2001 7,896 141 2002 8,756 175 2003 8,795 166 For summary information and reported purposes, the Medicines and Healthcare products Regulatory Agency groups the causes of medical device related adverse incidents into four categories:
- 1. Before delivery—issues relating to design, manufacture, quality control and/or packaging.
- 2. After delivery—relating to performance and/or maintenance failures and device degradation.
- 3. User error—where the device had not been used in accordance with the instructions for use.
- 4. No established link to device—where (a) the device was found subsequently to work as intended (possibly due to an intermittent fault. tampering, or user error) or (b) it was not available for inspection, or (c) because the report was made on precautionary basis.
The percentage of incidents falling into each of these categories in 2003 is shown in Table 2.
Table 2: Reported medical device related adverse incidents 2003 Percentage cause of incident All incident reports (number = 8,795)
Reported incidents involving a fatality
(number = 166)
1. Before delivery 37 12 2. After delivery 30 11 3. User error 18 36 4. No established links to device
44 62 >Note: Figures total more than 100 per cent. as multiple causes have been identified in some reports.