you raise some important questions but the field of medical device regulation is complex. The European Commission has been reviewing the system for over 2 years and the working of Notified Bodies is one of the key issues. In fact the MHRA in the UK isn't a Notified Body i.e a centre or company that assesses products and grants CE-marks indicating consumer safety allowing their release to EU markets (one in the UK is the BSI - British Standards Institute). In my view the key issue directly raised by the current breast implants scandal, apart from criminality, and amongst much media misreporting, is the manufacturing site inspection system, not the pre-market assessment/authorisation that NBs undertake though this doubtless could be improved. Implanatable devices such as breast and hip impants were raised to the highest level of risk classification, and thus requirements for pre-market data, in the EU system a few years ago but that in itself of course can't guarantee that incidents won't happen. There was some critical discussion of the issues in the British Medical Journal a few months ago.
Dr Alex Faulkner
Department of Political Economy
King's College London
tel. +44 (0)7980 374154 or (0)1273 473421
new book on medical technology: http://www.palgrave.com/PRODUCTS/Title.aspx?PID=275650
personal page: http://www.kcl.ac.uk/sspp/departments/politicaleconomy/people/academic/faulkner.aspx
From: Evidence based health (EBH) [[log in to unmask]] On Behalf Of KATE BLOOR [[log in to unmask]]
Sent: 03 March 2012 12:23
To: [log in to unmask]
Subject: medicines heathcare products regulatory authority Q's about transparency
The MHRA stands for 'medicines and healthcare products regulatory authority', and they operate under an EU directive as the UK's 'notifiable' body for IVMD's which is in-vitro-medical devices (only NHS offiicially) i.e. tests and equipment used in medical care. The have a responsiblity for 'post-use regulation of devices' and patient safety and are part of the DOH. The are currently dealing with the breast implant issues, and more recently an article in the Independant suggests there are serious problems with NHS hip-replacements too.
I hope someone will know something about this, however, I suspect that information is not easily available.
My questions are;
1. How does an issue or set of issues, become subject to a full blown investigation into a device, what criteria are used to make that assessment? There is some kind of risk assessment but its really not clear on their website what methodology is used.? What approach is taken to the is assessment of risk, is this risk in terms of level of harm, and how is that assessed, or is it numbers of people affected, for example, or is it ad-hoc and not driven by an set approach etc?
2. If a full blown investigation is launched into the potential failure of a product or device, what fixed or pre-dertermined approach or method is normally used to assess it, and does this take into account the use of the device in situ - what degree of emphasis is placed on the experience of the device from the patients point of view? Are the cases related to the interviewed, or data collected about them and so on?
3. When they use their 'experts' database , and is this an idependant process of selection, reflecting variety of disciplines or perspectives?
4. Is there any clear method to assessing evidence related to the device,such as peer reviewed science or clinical medicine etc, for their examination of the basis of claims of device failure - and would this include for example, a researcher examining the evidence using methods such as meta-analysis. I noticed that the new advice they sent out about information available on SSRI's subscribed to young people, was based on the work of a working-party that had been going for some time, and also, one published paper on the subject.
5. How does the MHRA explain their processes, and methods eg. 1/2/3/4 and are these clear to the ordinary public, or parts of the medical profession who might wish to report?
Any help would be appreciated.