Asked by: David Hanson (Labour - Delyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment (a) his Department and (b) the Medicines and Healthcare Products Regulatory Agency have made of (i) the rate of reported faults in heart pacemakers and (ii) research from UK and non-UK sources on heart pacemakers since 2010.
Answered by George Freeman
Clinicians are encouraged and manufacturers are mandated to report deaths and other incidents to the Medicines and Healthcare products Regulatory Agency (MHRA) if they suspect a device fault.
The numbers of United Kingdom deaths reported annually since 2010 to the MHRA involving patients implanted with approved pacemakers, are as follows:
Year | Deaths reported involving pacemaker patients |
2015 - present | 1 |
2014 | 8 |
2013 | 3 |
2012 | 3 |
2011 | 1 |
2010 | 4 |
According to registry data from 2014, over 35,000 pacemakers are implanted annually in the UK. Therefore the number of reported patient deaths listed above which could have potentially related to pacemaker failure represents no more than 0.01% of this population.
Analysis of MHRA investigation conclusions revealed that none of the above deaths resulted from a faulty pacemaker.
As the UK regulatory authority, the MHRA is responsible for monitoring the safety of medical devices once they have been approved for market. Although the majority of pacemakers are well functioning, the MHRA actively monitor the performance of implants using a variety of methods.
One key element involves the investigation of device-related adverse incidents, where manufacturers’ mandatory reports are supplemented by voluntary reports from clinicians and members of the public using the yellow card system.
The MHRA challenges manufacturers if it is believed that the proposed post-investigation action is inadequate to protect public health.
Every new incident, including those involving pacemakers, is assessed and assigned to an appropriate type of investigation according to its severity and the likelihood of obtaining further information on the cause of the event. All reports, even those unsuitable for further investigation, are fully recorded and subject to periodic trend analysis by the MHRA to look for signals suggesting any possible device-related problems.
In addition to scrutinizing manufacturers’ device data provided in incident investigations, and their published product performance reports, the MHRA also monitors relevant published research and articles on potential safety concerns as part of its surveillance of the medical device market. If evidence emerges that affects the safety of UK pacemaker patients, the Agency issues advice to the health service and takes any necessary regulatory action.
Furthermore the Agency actively engages with the clinicians and professional bodies to gauge their opinion on early indications for failure and problems encountered with device usage.
Asked by: David Hanson (Labour - Delyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many deaths there have been as a result of faulty heart pacemakers in each year since 2010.
Answered by George Freeman
Clinicians are encouraged and manufacturers are mandated to report deaths and other incidents to the Medicines and Healthcare products Regulatory Agency (MHRA) if they suspect a device fault.
The numbers of United Kingdom deaths reported annually since 2010 to the MHRA involving patients implanted with approved pacemakers, are as follows:
Year | Deaths reported involving pacemaker patients |
2015 - present | 1 |
2014 | 8 |
2013 | 3 |
2012 | 3 |
2011 | 1 |
2010 | 4 |
According to registry data from 2014, over 35,000 pacemakers are implanted annually in the UK. Therefore the number of reported patient deaths listed above which could have potentially related to pacemaker failure represents no more than 0.01% of this population.
Analysis of MHRA investigation conclusions revealed that none of the above deaths resulted from a faulty pacemaker.
As the UK regulatory authority, the MHRA is responsible for monitoring the safety of medical devices once they have been approved for market. Although the majority of pacemakers are well functioning, the MHRA actively monitor the performance of implants using a variety of methods.
One key element involves the investigation of device-related adverse incidents, where manufacturers’ mandatory reports are supplemented by voluntary reports from clinicians and members of the public using the yellow card system.
The MHRA challenges manufacturers if it is believed that the proposed post-investigation action is inadequate to protect public health.
Every new incident, including those involving pacemakers, is assessed and assigned to an appropriate type of investigation according to its severity and the likelihood of obtaining further information on the cause of the event. All reports, even those unsuitable for further investigation, are fully recorded and subject to periodic trend analysis by the MHRA to look for signals suggesting any possible device-related problems.
In addition to scrutinizing manufacturers’ device data provided in incident investigations, and their published product performance reports, the MHRA also monitors relevant published research and articles on potential safety concerns as part of its surveillance of the medical device market. If evidence emerges that affects the safety of UK pacemaker patients, the Agency issues advice to the health service and takes any necessary regulatory action.
Furthermore the Agency actively engages with the clinicians and professional bodies to gauge their opinion on early indications for failure and problems encountered with device usage.
Asked by: David Hanson (Labour - Delyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, what assessment he has made of whether there is a differential in waiting times for hospital services provided by hospital trusts in England for residents of (a) Wales and (b) England; and what guidance he has issued to such trusts on that matter.
Answered by Jane Ellison
No such assessment has been made, though a number of studies that include a comparison of elective waits between England and Wales have been published, including that by the Nuffield Trust.
Asked by: David Hanson (Labour - Delyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, how many patients with a postal address in Wales have used hospital services in (a) Countess of Chester, (b) Arrowe Park, Wirral, (c) Clatterbridge, Wirral, (d) The Christie, Manchester, (e) Agnes Hunt, Gobowen and (f) Liverpool Children's Hospital in the most recent year for which figures are available.
Answered by Jane Ellison
The information is not available in the format requested. Such information as is available is shown in the table below.
Counts of accident and emergency (A&E) attendances1, admitted patient finished admission episodes2 and outpatient attendances3 for patients with an Area Team of residence4 of Wales by the selected hospital providers5, 2013-14
Activity in English NHS Hospitals and English NHS commissioned activity in the independent sector | |||||
Hospital provider | A&E attendances | Finished admission episodes | Outpatient attendances | ||
Alder Hey Children’s NHS Foundation Trust | 155 | 2,942 | 6,703 | ||
Countess of Chester Hospital NHS Foundation Trust | 14,404 | 14,185 | 66,514 | ||
The Christie NHS Foundation Trust | - | 285 | 3,167 | ||
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | - | 4,520 | 40,577 | ||
Wirral University Teaching Hospital NHS Foundation Trust | 330 | 383 | 1,282 | ||
Source: Hospital Episode Statistics (HES), Health and Social Care Information Centre
Notes: | |||||
1 Official Source of A&E activity data | |||||
HES is not the official source of total A&E activity, this is the NHS England situation reports collection - http://www.england.nhs.uk/statistics/statistical-work-areas/ae-waiting-times-and-activity/ However, HES permits further analysis of A&E activity as there are a range of data items by which HES can be analysed. | |||||
2 Finished admission episodes | |||||
A finished admission episode (FAE) is the first period of admitted patient care under one consultant within one healthcare provider. FAEs are counted against the year or month in which the admission episode finishes. Admissions do not represent the number of patients, as a person may have more than one admission within the period. | |||||
3 Outpatient Attendances | |||||
Attendances at outpatient clinics. Includes first and follow-up attendances and telephone consultations, excludes did not attends (DNAs) and cancellations. | |||||
4 Area team of residence | |||||
The area team containing the patient’s normal home address. This does not necessarily reflect where the patient was treated as they may have travelled to another area for treatment. | |||||
5 Hospital Provider | |||||
A provider code is a unique code that identifies an organisation acting as a health care provider (eg NHS trust or primary care trust). Data from some independent sector providers, where the onus for arrangement of dataflows is on the commissioner, may be missing. Care must be taken when using this data as the counts may be lower than true figures. | |||||
Asked by: David Hanson (Labour - Delyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether his Department is providing funding to the International Centre for Drug Policy to produce a National Programme on Substance Abuse Deaths to report for 2014.
Answered by Jane Ellison
Public Health England officials are in discussions with St George's, University of London, concerning the production of a National Programme on Substance Abuse Deaths report covering the year 2013.
Asked by: David Hanson (Labour - Delyn)
Question to the Department of Health and Social Care:
To ask the Secretary of State for Health, whether he plans to publish the number of deaths caused by volatile substance abuse in England and Wales in (a) 2013-14 and (b) future years.
Answered by Jane Ellison
The Department has asked Public Health England to consider how future data on volatile substance abuse deaths might be collected and reported. Additionally, on 17 October 2014, the Office for National Statistics published a one-off report providing data on drug related deaths involving volatile substances and nitrous oxide in England and Wales, 1993–2013. A copy of the report is attached.