There are currently over 500,000 different medical devices and in-vitro diagnostic devices on the market in the UK, produced by over 3,500 companies turning over around £22bn, providing jobs for 120,000 people and accounting for £5bn in exports annually. Yet there is at present no comprehensive list of devices on the market. Groups formed by patients harmed by devices — such as vaginal mesh and breast implants — have found a shocking lack of transparency over adverse effect data, and such low standards for device approval that there are serious risks to patients.
The HealthWatch Symposium 2019: Evidence, Healthcare and Medical Devices & Implants aimed to clarify the current issues facing evidence based healthcare in the field of medical devices and implants, and to identify areas where HealthWatch and similar organisations might most productively concentrate their efforts.
This important background paper, prepared for us by HealthWatch member and TranspariMED founder Till Bruckner, focuses on evidence requirements for medical devices in the UK in the context of recent media investigations. It gives an overview of governance in the UK for these devices. It also demonstrates some of the conflicting pressures and requirements in this area.
Groups formed by patients grievously and sometimes permanently harmed by medicines and medical devices — such as valproate-damaged babies, and women with complications of vaginal mesh and breast implants — have found a shocking lack of transparency over adverse effect data, and such low standards for device approval that serious risks to patients are inevitable. When the Independent Medicines & Medical Devices Safety Review (the “Cumberlege Report”) is finally published, HealthWatch is hoping to see action on 5 demands that will show patients are being put before profit.
The Review, chaired by Baroness Julia Cumberlege, aims to examine how the healthcare system has responded to concerns raised by patients and families about three medical interventions: the hormone pregnancy test Primodos, the anti-epileptic drug sodium valproate, and vaginal mesh. It was due to be published today, 24th March 2020, but is now delayed indefinitely as a result of COVID-19.
Surgical mesh products are among over 500,000 different medical devices and in-vitro diagnostic devices on the market in the UK, produced by over 3,500 companies turning over around £22bn, employing 120,000 people and accounting for £5bn in exports annually. “Yet there is currently no comprehensive list of devices on the market, no way of identifying and tracking them, and no clear idea of how many patients are harmed,” says Dr Susan Bewley, HealthWatch’s chair. “The government is keen to protect business, but this should not come at the expense of patient safety.” HealthWatch has also supported efforts to get more transparency into the system because commercial secrecy can harm (or even kill) people. “Patients are entitled to know who’s paying their doctors and scientists when innovations are rushed to market without safe post-marketing monitoring systems”.
In November 2019 HealthWatch wrote a letter to Baroness Cumberlege to ask the Independent Medicines & Medical Devices Safety Review to demand that those who implant a device must know (and be able to explain to the patient):
- what it is and what its constituents are
- how it is identified and tracked
- how the evidence shows that it works
- what risks are involved
- what to do if things go wrong.
In response, the Review team is to publish our letter and evidence on their website when the Review is published.
Our 5 demands appear in a HealthWatch Strategy document resulting from discussions at the June 2019 HealthWatch medical symposium: Evidence, Healthcare and Medical Devices & Implants.
The Independent Medicines & Medical Devices Safety Review was announced in the House of Commons in February 2018 by Jeremy Hunt MP, the then Secretary of State for Health and Social Care, and was due to be published at 11:30am on 24 March 2020, see the IMMDS Review website.
24 March 2020
The committee now has to decide how to take this forward. We need the ‘many eyes’ and wisdom of our members to determine the strategy we can reasonably take forward.
The symposium was built on an excellent background paper commissioned from Till Brucker, and many congratulations are due to John Kirwan and team for steering and reporting on this pioneering event. It brought many diverse and expert stakeholders together to listen, think and talk about evidence and healthcare, innovations and risks, outcomes and regulation. Whether you attended or not, you will be stimulated and will learn a lot. At our next trustees meeting we will be pulling together a vision for the future and actions we (or others) can make.
Please do take the time to read the reports, maybe with a cup of tea, and then respond by Friday 6th September using the form below.
Thanks in advance.
Chair of Trustees
27 August 2019
We would like your responses to the following:
- Having read the HealthWatch reports, in the future I would like to see…
- I think specific actions to achieve these aims could include…
Please provide your responses on this contact form.
Thank you for your help. We'll let you know what we've decided to do.