§ Andrew MackinlayTo ask the Secretary of State for Health what reporting regime exists for incidents where the anaesthetic breathing system is believed to have(a) been blocked and (b) malfunctioned. [36263]
§ Ms BlearsThe Medical Devices Agency (MDA), an executive agency of the Department, currently operates two systems for reporting adverse incidents involving medical devices.
Incidents involving blocked or malfunctioning breathing system components should be reported to the MDA by health care professionals or the National Health Service through the user reporting system or, if the report comes from a manufacturer, through the agency's vigilance reporting system.
At the beginning of each year, the MDA publishes advice in the form of a safety notice to health care professionals to encourage them to report adverse incidents and to outline how to do so. MDA's website also provides advice on reporting incidents involving medical equipment, together with reporting forms and an online reporting facility.
MDA liaison officers have been appointed for each health authority, NHS trust and social services department in England (also for the majority of primary care trusts) with a dual role of raising awareness of the need for incident reporting and secondly to ensure that any safety advice issued by MDA is disseminated within their organisation to those who need to know.
The mandatory scheme for reporting adverse incidents relating to medical devices, often termed vigilance reporting, is an obligation laid upon all European Member States via the Medical Devices Directives. These Directives have been implemented in United Kingdom law via the Consumer Protection Act which places statutory obligations on manufacturers to report incidents which led to, or could have led to, death or serious injury.
§ Andrew MackinlayTo ask the Secretary of State for Health if he will make a statement on the police investigation into blockages discovered in anaesthetic breathing systems, as part of Operation Orcadian; and when he expects these will be concluded. [36264]
§ Ms BlearsAfter discussion with the Essex police I am able to make the following statement.
A police investigation commenced with the tragic death of Tony Clowes at Broomfield Hospital, Chelmsford on 18 July 2001. Further incidents involving blocked anaesthetic breathing equipment components came to light and a linked enquiry was launched headed by Essex Police under the name Orcadian.
The basis of the enquiry and the linking process was to look for a common factor. As the enquiry progressed a number of other incidents were reported from a number of sources, including patients who felt they may have been involved in an incident in the past. Some manufacturing faults were also reported.
In many cases the information available is, or was, very scant. There have been difficulties in obtaining accurate accounts and records for incidents that are historic and 1416W which may not have been considered significant at the time. Some of the incidents involved date back to the late 1980s.
During the course of the investigation, experiments were carried out which showed that a blockage could be replicated whilst the items were in storage. This finding changed the focus of the enquiry from 'whom' to 'how'.
To date no common factor has been found although the enquiry is still ongoing.
Orcadian has been a joint enquiry involving nine police forces and the close co-operation of the National Health Service, Health and Safety Executive and the Department of Health.
The Medical Devices Agency (MDA) has assisted the police by providing Orcadian with advice on breathing systems and their use. Since the enquiry began, the MDA has published three Hazard Notices to advise and alert users to related safety issues as they have emerged from the police enquiry.
It is difficult to predict at this stage when Orcadian will be concluded.
§ Andrew MackinlayTo ask the Secretary of State for Health how many incidents relating to the blockage of anaesthetic breathing systems are believed to have occurred within the NHS in each of the past three years; and if he will make a statement. [36265]
§ Ms BlearsThe Medical Devices Agency (MDA) report that there are three main ways in which anaesthetic breathing system components can become blocked. These are: manufacturing problems; user error; and possible tampering.
The MDA adverse incident database holds the following information for each type of blockage over the past three years:
Manufacturing problem User error Possible tampering 1999 1 1 1— 2000 2 1 1— 2001 4 9 7 1 None reported The increase in reports for 2001 may be attributed to the publication, by MDA, of three hazard notices raising the awareness of the possibility of blockages, together with the raised profile brought about by media coverage of the police Operation Orcadian.
Some of the reports relating to possible tampering are historical events that were reported following MDA's action and the police investigation. All seven incidents are subject to ongoing investigation within Operation Orcadian.
Those reports categorised as manufacturing problems were investigated by MDA and appropriate corrective action has been taken by the manufacturer to reduce the likelihood of re-occurrence. In some cases the product was recalled.