NHS Finance


Trusts to track high-risk devices

Four NHS trusts are taking part in a new tracking system trial to improve monitoring of high risk medical devices, the MHRA has announced.

The project will track breast implants, heart valves and pacemakers, incorporating unique device identifiers into patient electronic records and national Hospital Episode Statistics databases, as well as analysis by the Clinical Practice Research Datalink (CPRD).

It will enable the MHRA to better assess the performance of high-risk medical devices and to trace patients in the event of a device recall or safety alert.

The four trusts are: Freeman Hospital in Newcastle, Christie Hospital in Manchester, Leeds General Infirmary and Birmingham University Hospital.

John Wilkinson, the MHRA’s director of medical devices, said: “The PIP breast implants episode is believed to be a case of deliberate fraud but it highlighted areas where medical devices regulation need strengthening in the UK and in Europe.

“The new tracking system for medical devices that we are piloting is still in the early stages of development, but we hope it will help us to improve the safety information we receive so that we can alert patients and healthcare professionals about potential safety problems faster.

“This is one of 11 projects we established in response to the recommendations made by Lord Howe. We have already made good progress in a number of these and establishing an audit programme that ensures that European notified bodies – which assess the safety of medical devices before they are sold – meet consistently high standards was a key aim for us. We are continuing to work hard to ensure that the regulatory system is protecting patients from unsafe medical devices.”

Health minister Lord Howe said: “Protecting the health and well-being of people who have been given medical devices is vitally important. Serious lessons need to be learned from the PIP scandal.

“The MHRA has identified new measures to help improve the monitoring of medical devices including implants. I hope its ongoing work, and the work of the Department, will reassure the public that we have identified the lessons and have taken steps to act on them.”

Tell us what you think – have your say below, or email us directly at opinion@nationalhealthexecutive.com


There are no comments. Why not be the first?

Add your comment

Please enter the code shown in the image into the box below
(note: this is case sensitive)

Can't read this one? Try another

national health executive tv

more videos >

latest healthcare news

Faulty NHS machines leading to deaths

25/07/2014Faulty NHS machines leading to deaths

Urgent action must be taken by the NHS to repair faulty medical equipment that has led to the deaths of more than 300 people in 2013 and thousand... more >
Hospice charity wants to cut hospital deaths with NHS help

24/07/2014Hospice charity wants to cut hospital deaths with NHS help

A national hospice charity has called on the government to back a programme which aims to reduce the number of people dying in hospitals by 50,00... more >
Auditors highlight financial concerns at 19 NHS trusts

24/07/2014Auditors highlight financial concerns at 19 NHS trusts

Auditors have referred 19 NHS trusts to the health secretary in the last year for failing to meet their statutory break-even duty, compared with ... more >

editor's comment

01/06/2014A new era – or more of the same?

Welcome to this larger-than-usual edition of National Health Executive, with even more features, analysis, news, views and interviews than usual. With thousands of NHS managers, directors and clinicians soon to meet up in Liverpool for the annual NHS Confederation conference, we’ve got a preview of the show, including information about the exhibitors, speakers, venue and the events you should be sure not to miss. Our guide begins ... read more >

featured articles

View all News

last word

Active by Design: a new movement to improve the health of the nation

Active by Design: a new movement to improve the health of the nation

Kathy MacEwen, head of programmes for the Cabe Team at the Design Council, discusses the new Active by Design initiative, which promotes good design to encourage greater levels of daily physical... more > more last word articles >

the scalpel's daily blog

Let’s get past the rhetoric of seven-day services

23/07/2014Let’s get past the rhetoric of seven-day services

Sir Bruce Keogh, NHS England’s national clinical director, has once again stated that the provision of seven-day services across the NHS is his “number one priority”. During an NHS Improving Quality event in London, representatives of the 13 Early Adopter communities set up as part of the ‘7-Day Service Improvement... more >
read more blog posts from 'the scalpel' >

healthcare events

International Digital Health and Care Congress Improving health through the use of technology

10 Sep 2014

What is the future for health and social care? Find out at this three-day event that will ...

read more >

Making better decisions on public health spending: Getting to grips with value for money

18 Sep 2014

One-day conference at The King’s Fund! With local authority public health budgets be...

read more >

Realising the potential of primary care: the role of general practice

25 Sep 2014 09:00

This conference is aimed at general practices, and those working in community settings, who are...

read more >
view all events

events calendar


July 2014

mon tue wed thu fri sat sun
30 1 2 3 4 5 6
7 8 9 10 11 12 13
14 15 16 17 18 19 20
21 22 23 24 25 26 27
28 29 30 31 1 2 3
4 5 6 7 8 9 10


Room for improvement

28/05/2014Room for improvement

A new report has shown that more needs to be done to prevent sharps injuries, says Paul de Raeve, Secretary General of the European Federation of N... more >
The opportunity of EAMS – earlier guidance is only the start

28/05/2014The opportunity of EAMS – earlier guidance is only the start

Whether in health, education or finance, innovation isn’t simply about creating something new. To have impact, promising products, tools and ... more >
Changing how we change the NHS

28/05/2014Changing how we change the NHS

The NHS is the biggest single healthcare system in the world and it deserves to be recognised as being the best at healthcare improvement in the wo... more >
The 10 important features of Intermediate Care

28/05/2014The 10 important features of Intermediate Care

Steph Palmerone and Mike Speakman have been looking at successes and failures in Intermediate Care. They have come to some very clear conclusions. ... more >


Examining nursing education in England

28/05/2014Examining nursing education in England

Jackie Smith, chief executive of the Nursing and Midwifery Council, talks to NHE about the new Shape of Caring review, which has been launched to e... more >
Improving access to patient information at the country’s biggest health and care trust

28/05/2014Improving access to patient information at the country’s biggest health and care trust

Amy Freeman, chief information officer at Staffordshire and Stoke-on-Trent Partnership NHS Trust, spoke to NHE to explain how investing £13m ... more >
Self care is for everybody

28/05/2014Self care is for everybody

Susan Swientozielskyj, head of long term conditions in the Nursing Directorate for NHS England, and a board member of the Self Care Forum, talks to... more >
‘I don’t think we should be deterred in any way by worrying about the political reaction’

28/05/2014‘I don’t think we should be deterred in any way by worrying about the political reaction’

The Barker Commission seems set to make radical recommendations in its final report on health and social care integration later this year. NHE... more >

health service focus

  • 28/05/2014Developing new system leaders

    Chris Lake, head of professional development at the NHS Leadership Academy, discusses the new Intersect programme, which will help develop the next...
  • 28/05/2014Online consultations – the future?

    Leicester Medical School is the first in the country to teach its first year junior doctors how to hold online consultations. NHE spoke to teaching...
  • 28/05/2014Improving efficiency with eProcurement

    NHE takes a look at what the Department of Health’s newly launched eProcurement strategy will mean for trusts across the country, with input...
  • 28/05/2014Reforming regulation

    Tim Spencer-Lane, a lawyer at the Law Commission responsible for the review into regulation of health and social care professional regulation in the...
View all News