Sources of pertinent data
used in a clinical evaluation
In the clinical evaluation report of medical
device. A/c to MEDDEV 2.7/1 guidance, in stage 1 clinical evaluation covers
Data generated and held by the manufacturer and data retrieved from the
literature. Data relevant to the clinical
evaluation may be held by the manufacturer or a third party (The
responsible person who does the investigation of i.e., Appointed doctor or labs
who did bench tests and biocompatibility tests), or be available in the
scientific literature, for the device in question or for comparable devices.
The manufacturer is responsible for identifying data relevant to the medical
device.
1.
Data generated and held by the manufacturer
Pre-clinical data (e.g., lab testing), pre-market
clinical trials, risk management, and PMS are all included in data retrieve by
the manufacture. The CER should summarize, appraise, analyse, and reference all
data, not just those generated in Europe but also the data from other countries
such as FDA, MHRA etc. Risk management and PMS reports are typically large
documents that include documentation of quality control reports, complaints,
sales numbers, and data from external databases.
Sources of data in data generated and held by the manufacturer
All pre-clinical safety reports, such as bench test
reports, involve verification and testing data as well as clinical data
generated by risk management activities and PMS programs is comes under data
generated and held by the manufacturer. If a manufacturer decides to use
clinical experience data, it is critical that any reports or data collection
contain enough information to conduct a systematic and logical assessment of
the data and reach a conclusion about its significance in terms of the device's
safety, and clinical performance, and/or effectiveness. The manufacturer
collects post-market
surveillance reports, which frequently include information about the
medical device's regulatory status, regulatory actions taken during the
reporting period, a list of adverse events, and estimates of the frequency of
adverse events.
These reports of data analyses may provide
reasonable assurance of safety, clinical performance, and/or effectiveness for
some medical devices. A report concludes, device-related adverse events, with
comments on whether reported device-related adverse events are predictable
based on the medical device's mode of action, may be useful. Risks discovered
that were not previously included in the risk management documentation must be
addressed, along with the additional management that is required.
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2. Data
generated through literature searching
Literature searching can be used to identify
published clinical data that is not in the manufacturer's control and could
help the manufacturer establish acceptable safety, clinical performance, and/or
effectiveness of a medical device. The data collected from literature
searches may be directly relevant to the device under consideration,
such as reports of third-party clinical research of the device under
consideration, or adverse event reports. For some medical devices, clinical
data derived from literature searches will provide the vast information of
clinical evidence. Thus, reasonable attempts should be made to perform a
thorough search while doing a literature review. Published data must be
evaluated in terms of its potential contribution and weighting in determining
both the performance and safety of the device in question. The key elements of
a literature search approach should be well-constructed review questions.
Review questions about safety, performance, intended purpose, side effects,
state of the art, alternative availability, and risks (clinical). A process for
identifying, selecting, and compiling relevant articles to address these
concerns should be defined. This should be prepared and carried out by people
who are knowledgeable with information retrieval while considering the
manufacturer's clinical evaluation scope. The literature search protocol should
include the data sources that will be used and a justification for their selection,
a good databases platform for a good result.
Following the completion of the literature search,
a report should be prepared to describe the results of the search.
Source of data
Scientific databases such as PubMed, Medline,
Cochrane library, EMBASE, PDQ evidence, PMC evidence, trip, and so on are some
of the sources of data used in literature searches. Google Scholar, company
websites, and the FDA are the most common places to look for information on the
internet. Information from instructions for use, implant registries, and data
presented at convention are examples of non-published data. By forming keywords
related to each of the review questions, the search is carried out across
various sources.
It is concluded that data from manufacturers can help
to determine whether any reported device-related adverse events can be
predicted based on the medical device's mode of action. If so, then it might be
possible to reduce the risks of any adverse events that may occur. And some
other risks that were not previously included in the risk management documents
also, will be identified. Whereas data obtained through literature searches
helps in the identification of residual risks, performance, and adverse events
by comparing the subject medical device to other similar or equivalent devices
that are already placed in the market to ensure safety, performance, and ease
of use and to help the subject device to become as safe as possible.
