Clinical Evaluation Literature Search Protocol

Clinical Evaluation Literature Search Protocol

The results from the Clinical evaluation literature search protocol are related to the essential information required for establishing the safety & performance of the subject device or to the equivalent device.

This will help to establish current knowledge and or state of the art (SOA). MEDDEV 2.7.1 Rev 4 and MDR article 61 mandate it.

Scientific Literatures prove the medical device clinical safety and performance through data obtained from various literatures which are relevant to the device under evaluation for proving its clinical safety and performance

What is the purpose of Clinical Evaluation Literature Search Protocol?

The purpose of Clinical Evaluation Literature search Protocol is to prove the medical device clinical safety and performance through data obtained from various literatures which are relevant to the device under evaluation for proving its clinical safety and performance.

Clinical Performance: Behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).

Clinical Evaluation Literature Search Protocol

Sources Of Literature Search

Among the different sources of clinical literature, a comprehensive search strategy in multiple databases must be followed. Appropriate and maximum number of relevant keywords should be used on the different sources of search.

  • Scientific Literature Database
  • Internet Searches
  • Non-published data
  • Citations referenced in scientific literature

The search strategy should be documented and justified.

Scientific Literature Databases

  • MEDLINE or PubMed.
  • Additional databases such as European PMC shall be searched to ensure the adequate coverage of devices and therapies in use in Europe, to identify relevant clinical trials and publications of user experience.
  • Progress the searches by device name and manufacturer (e.g. EMBASE (biomedical literature database) /Excerpta Medica, the Cochrane CENTRAL trials register, etc.).
  • Due to frequent changes in information coverage and search features available in scientific databases, the criteria for selecting adequate databases therefore must be defined and re-evaluated on a regular basis.

How to effectively conduct Literature search for Medical Device

The selection of literature should be objective and justified, i.e. the selected literature should include all relevant data, both favourable and unfavourable. With respect to the clinical evaluation, the clinical evaluators must assess the degree to which the selected papers reflect the intended application/ use of the device.

  • Develop Clinical Evaluation literature search protocol based on subject
  • Literature search planning based on the available resources and subject device
  • The key words / strings used for search should not be too broad or too narrow.
  • List all data bases used for search for eg medline/ pubmed, EMBASE, the Cochrane register etc)
  • To review the abstracts of the studies carefully to save time
  • The Literature should be directly to the device or to equivalent device, similar device having same intended use, inclusion/exclusion criteria etc

How should be the output of Literature search

  • The relevant literature abstract should describe the purpose, method and results.
  • The data relevancy in terms of intended use, user population, use environment, patient population, safety and performance of the literature data to the device under evaluation should be provided.
  • The current knowledge/ the state of the art must be provided for the proper conduct of the appraisal and analysis of the clinical data of the device under evaluation and the equivalent.
  • The literature collected should be related directly to the device in question (e.g. publications of clinical investigations of the device in question that have been performed by third parties, its side effects or complications, incidence reports) and/or to equivalent device, benchmark devices, other devices, and medical alternatives available to the intended patient population.
  • Over all conclusion of the literature output should be mentioned and it should satisfy the clinical safety and performance of the device under evaluation in accordance with its intended purpose.

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