Clinical Evaluation using the Literature Method - Example or information wanted

S

SK Vision

#1
Does anyone out there have a template or example of how a Clinical Evaluation using the Literature method might be formatted?

Thanks!

Sarah
 
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E

E. Madsen - 2012

#3
SteveK,

How did your audit go? Do you have a more complete example. I have attached my literature review report example. Please provide feedback.

I have a question related to the literature review. We recognize the requirements for literature review. One of those requirements is to evaluate the authors’ background and expertise in relation to the device and/or procedures involved (NB-MED 2.7 section 4.2.1.iv.). It has been challenging for us to obtain author information on some of the articles we have reviewed, especially for those authors that are out of the country.

For those articles that we are unable to find sufficient author information, we were planning on using this statement in our report/technical file.

“The background of the author(s) of this article could not be established. The wait of this article in our overall review is less based on our lack of information."

Thank-you!!
Emily Madsen
 

Attachments

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SteveK

#4
Hi Emily,

Thanks for the interest, the audit went well – a few minor NCs (would have been surprised if none in a level 3), but all corrected to auditor’s satisfaction. With respect to the clinical evaluation, he made an observation (OFI) that some of the references I used did not show clearly enough the connection to the device in question. He was happy with the approach however. Your more detailed analysis (as you indicate) is based on NB-MED 2.7 – Clinical Investigations, Clinical Evaluation – i.e. in my eyes this means citing ‘clinical trials’ literature, totally different animal (see BS EN ISO 14155-1) – thus the authorship etc requirements – not a good idea. I have used MEDDEV 2.7.1 for my approach – I think you should have a look at this instead. So anyway, post audit, what I have done now is that for each reference cited, I have included either an abstract (all I could find in a number of cases) or a short precise of the article/book chapter – with pictures, diagrams etc as these often clearly show design or use equivalence. This document is therefore much more complete as you request, but has become a bit too specific and confidential to easily share a completed example.

All this said, I like your citation hits and applicability, because I do something very similar as I monitor alerts, recalls, advisory notices (FDA, MHRA, TGA, MDB, BfArM, Afssaps etc) as part of my post market surveillance.

For clinical evidence definitions, if not already done so, check out SG5/N1R8:2007 and SG5/N2R8:2007 at the GHTF website

Hope this helps.

Steve
 
E

E. Madsen - 2012

#5
Hi Emily,

Your more detailed analysis (as you indicate) is based on NB-MED 2.7 – Clinical Investigations, Clinical Evaluation – i.e. in my eyes this means citing ‘clinical trials’ literature, totally different animal (see BS EN ISO 14155-1) – thus the authorship etc requirements – not a good idea. I have used MEDDEV 2.7.1 for my approach – I think you should have a look at this instead.

Steve
Thanks for the information! Glad the audit went well. We have been using both NB-MED 2.7 and MEDDEV 2.7.1, but relied more heavily on MEDDEV. As for your comment regarding the evaluation of the authors, the first bullet-point under section 4.3.1.(i).e. states that "the relevance of the author's background and expertise in relation to the particular device and/or medical procedure involved" should be addressed. If we don't identify each author's backgrounds then how can we assess the articles properly.

What do you think? I appreciate your comments!!

Emily
 
S

SteveK

#6
Emily,

Where there are published papers referencing clinical trials information, these will have had a peer group and/or editorial review; otherwise they would not be published. Therefore, would not the author’s competency have been checked out by default? Having said this, think about falsified drug trial data reported over the years! I think it unlikely that you would be able to find unpublished primary data. Anyway, I think using this document (NB-MED 2.7) as a guide is OTT for class II devices. If your products are class III, then I suppose it would be a different matter. Would you not need to be a medic (which you may well be) to go into the required review details anyway?

Steve
 
S

schlupp

#7
Hi Emily and Steve,
I am Johannes from germany and we are just in this theme you are describing. We have still to do the literature route to our class I products, stehoscopes. Did your example work this way?
kind regards
Johannes
 
S

SteveK

#8
Hi Johannes,

I would expect there would be a large amount of references to stethoscopes out there on the web. When you do find something similar referenced, note the source and include a relevant extract or review from the journal, book, alert etc on your clinical evaluation document/form/report (I often use screen capture e.g. for pictures or diagrams of items similar to our own). You may only find an abstract due to internet sites requiring payment for a full article (try Google Books as one source of literature as well as my previous suggestions). Is this the sort of information you require – not totally clear from your post?

Steve
PS welcome to the community!
 
S

schlupp

#9
Hi Steve,
thanks for your quick answer. I will start searching for the correct google books. The PDF you posted some time ago as an example to the "literature route" was the search word in google, I found this forum. Did the build-up of your pdf work to pass the authorities?

Johannes
 
S

SteveK

#10
Hi Johannes,

As I indicated, the auditor was fine with the (pdf) form structure. It was just an observation (OFI) that originally there was just the reference quoted in my clinical evaluation form, but no actual detail e.g. an extract. Often the auditors just have a particular opinion. If you were writing a technical paper for publication you would tend to just cite references as supporting evidence - this is what I was used to.

Steve
 
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