Interesting questions, Kate (which unfortunately I can't be
much help in answering). However, they would be good questions
to put to the Evidence-Based-Health list (also JISCMAIL):
https://www.jiscmail.ac.uk/cgi-bin/webadmin?A0=EVIDENCE-BASED-HEALTH
(and could be a good antidote to the sneezing into the elbow
which has been prevalent lately).
Best wishes,
Ted.
On 03-Mar-2012 KATE BLOOR wrote:
> 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.
> Kate Bloor
> LymeResearchUK
>
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E-Mail: (Ted Harding) <[log in to unmask]>
Date: 03-Mar-2012 Time: 10:55:09
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