NHS Finance

10.06.13

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

Comments

There are no comments. Why not be the first?

Add your comment

 

national health executive tv

more videos >

latest healthcare news

CQC rates major GM foundation trust as ‘requires improvement’

09/12/2016CQC rates major GM foundation trust as ‘requires improvement’

Pennine Care NHS FT has been rated as requires improvement following an inspection by the CQC. The trust, which provides mental health, comm... more >
Providers urged to address learning disability issues as huge health gaps revealed

09/12/2016Providers urged to address learning disability issues as huge health gaps revealed

The largest report ever conducted into the health of people with learning disabilities in England has led to calls for commissioners to address t... more >
Paramedics receive ‘long overdue’ upgrade to Band 6 pay

09/12/2016Paramedics receive ‘long overdue’ upgrade to Band 6 pay

The Department of Health, NHS Employers and ambulance unions have agreed that paramedics’ salaries will be re-banded nationally, potentiall... more >

editor's comment

02/12/2016We must learn from the inevitable change

STPs represent the one thing that many people, organisations and systems do not like: change. However, the highly ambitious plans, which have been criticised for their lack of early engagement and top-down approach, are a necessity if the health and care sector is to address the unprecedented challenges it faces.  Whether it is through service redesign, financial savings, back-office consolidations or greater moves towards integrat... read more >

last word

How can behavioural insights make care more person-centred?

How can behavioural insights make care more person-centred?

Michael Hallsworth and Hannah Burd of the Behavioural Insights Team explain how two new guides aim to deliver more effective person-centred care. The key to delivering person-centred care is... more > more last word articles >

the scalpel's daily blog

Framework to focus on compassionate and inclusive leadership

09/11/2016Framework to focus on compassionate and inclusive leadership

Professor Michael West, senior fellow at The King’s Fund, who has been involved in the development of the National Improvement and Leadership Development Framework, explains why compassionate and inclusive leadership will be core to the framework. National reports into NHS functioning without exception describe the importance of cul... more >
read more blog posts from 'the scalpel' >

comment

Dudley CCG: MCP model success requires time, commitment and trust

09/12/2016Dudley CCG: MCP model success requires time, commitment and trust

Paul Maubach, chief executive officer at Dudley CCG, discusses the early success and challenges of the Dudley Multi-specialty Community Provider ... more >
Social prescription: A trojan horse for a health creating community?

09/12/2016Social prescription: A trojan horse for a health creating community?

Dr Michael Dixon, social prescribing lead at NHS England, discusses the opportunities and challenges facing social prescribing. Social presc... more >
Change the climate

07/12/2016Change the climate

Jill DeBene, CEO of the Institute of Healthcare Management (IHM), argues that there needs to be radical change to the climate in the NHS to encou... more >
Increasing patient safety through structured conversations

07/12/2016Increasing patient safety through structured conversations

Sign up to Safety’s national campaign director, Dr Suzette Woodward, explains how structured conversations and helping people talk to each ... more >

interviews

Leadership development should be for all in health and care

07/12/2016Leadership development should be for all in health and care

Back in August, Stephen Hart joined Health Education England (HEE) as the organisation’s new director of leadership development, which incl... more >
The powerful link between staff and patient satisfaction

03/10/2016The powerful link between staff and patient satisfaction

David Behan CBE, chief executive of the Care Quality Commission (CQC), talks to NHE about the correlation between high rates of staff satisfactio... more >
Dame Fiona Caldicott: We’re not quite ready for sharing back-office function on data security

07/07/2016Dame Fiona Caldicott: We’re not quite ready for sharing back-office function on data security

NHE’s David Stevenson talks to Dame Fiona Caldicott following her much-awaited Review of Data Security, Consent and Opt-Outs. In the f... more >
Benchmarking what good looks like

01/07/2016Benchmarking what good looks like

Lord Carter of Coles discusses the findings of his recent review, the work of NHS Improvement (NHSI) and the importance of benchmarking. Dav... more >

health service focus

View all News