CERs Literature Databases - Searching for data to evaluate

Ronen E

Problem Solver
Staff member
Moderator
#11
RonenE used the term "jog." On LinkedIn, it would be "inspire." I'm not a big fan of inspiring. Nor of jogging, in all meanings of the word. :)
I didn't give this wording tonnes of thinking before posting, and I didn't mean anything specific. It's just a term of speaking.

Usually when I ask a question at Elsmar, it's at a point where I already have some knowledge or opinions about the subject so I start by sharing what I've already gathered. It doesn't always work, but it usually does.
 
Elsmar Forum Sponsor
#13
Which literature databases are your go-to databases for your CERs?
Embase
PubMed
Cochrane Collaboration and Library
NICE (UK)
ClinicalTrials.gov (USA)

Embase and PubMed are online databases providing comprehensive and searchable access to scientific and medical peer reviewed journals. The others provide supplemantary information on clinical trials, guidelines and meta-analysis.

For adverse effects:-

MHRA Medical Device Alerts (UK)
SwissMedic Recalls and FSCA
TGA DAEN (Australia)
US FDA MAUDE
US FDA Medical Device Recalls
US FDA Total Product Life Cycle
This selection...is designed to provide broad coverage of the databases that are publicly available.
 

Watchcat

Trusted Information Resource
#14
Pads38, that's a great list, thanks.

Since posting my question, I have been thinking about the difference between searching for data on your device versus data on "equivalent" devices. I've worked mostly with Class III devices supported by a clinical trial. For these devices, published literature takes a bit of a back seat, where it is a key source of clinical data for devices not supported by a clinical trial. You can usually limit the literature search to publications of data on your device, rather than including equivalent devices. In addition, the devices were on the market in the US, so they were also subject to FDA oversight and reporting.

For this situation, MAUDE does not seem worth searching, because all of the reports for your device in MAUDE are also in your complaint files (and vice versa), and therefore those events will be included in the evaluation of your complaint data. More than that, if you included both the MAUDE data and your complaint data, you would be reporting many of the same adverse events twice. The same applies to FDA's recalls. Hard for FDA to recall your device without you knowing about it and any adverse events that inspired it. So it seems to me that FDA data is useful for finding adverse events for equivalent devices, but not for your own. Or am I missing something here?

Embase is described as "a biomedical and pharmacological bibliographic database of published literature designed to support information managers and pharmacovigilance in complying with the regulatory requirements of a licensed drug." When I first started writing CERs, I searched it several times and and never found anything in it, so I finally stopped searching it. Has anyone found device data in Embase?

I'm not a big fan of clinical trial databases as a source for CER data. Like MAUDE reports, they strike me as unconfirmed rumors, not "valid scientific evidence." I am skeptical enough of data that makes it into a peer reviewed publication. Also, if the publication reports data in your clinical trial, then you are once again reporting the same data twice.
 
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#15
The lists in the previous post are not really my choice - since Rev 4 we have had to 'out-source' the writing of our CERs to a CRO. Myself I tended to just use Google Scholar. Either way we end up with a whole load of peer reviewed academic papers that, in the methods section, just happen to mention our device. The 'effectiveness' part is that they are reporting use in n=x subjects, safety is the lack of reported problems.

And we did have a MAUDE report that was never reported to us (the manufacturer). So it was not a 'complaint' but we did do investigation when we became aware of the MAUDE listing.
 

Watchcat

Trusted Information Resource
#16
The lists in the previous post are not really my choice.
I didn't take it as such. It's a good list to consider. Seems to be very comprehensive. I try to be aware of new sources, but it can be hard to keep up.

since Rev 4 we have had to 'out-source'
One thing I recently realized in reading through the MDR is that, if CAs and the NBs really do their jobs this time (not holding my breath), a lot more device companies are going to realize that they can no longer continue to "have to" outsource all things clinical.

I tended to just use Google Scholar.
My experience with Google Scholar was that all the results could be split into two groups: 1) publications that were in PubMed and 2) stuff that would be excluded in the appraisal of the data. So you just ended up doing a lot of extra work to appraise the additional material with a near-zero probability of getting anything useful above and beyond what you got from searching PubMed.
 
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Watchcat

Trusted Information Resource
#17
we did have a MAUDE report that was never reported to us (the manufacturer). So it was not a 'complaint' but we did do investigation when we became aware of the MAUDE listing.
Yes, there are exceptions to every rule, but the odds of a stray report having a meaningful impact on the overall outcome of a clinical evaluation are virtually zero. Given that the overwhelming majority of adverse events associated with use of a medical device are never reported anyway, whether a clinical evaluation includes 9.6% or 9.7% of all adverse events associated with use of the subject device seems unlikely to have either clinical or statistical significance.

Thus I think MAUDE offers an extremely low return on time invested to maybe find one or two overlooked reports to include in a clinical evaluation. On the other hand, it might be worth doing to find the occasional report you didn't receive and would like to investigate for quality management purposes. Companies that think it is worth doing for this purpose are already doing it, and therefore, when it comes time to do a clinical evaluation, the overlooked reports have already been found and investigated. Usually "worth doing" is a risk-based decision, so the companies that find value in searching MAUDE for this purpose are probably those that market high-risk devices.
 
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