A Brief Record of Literature Retrieval in Clinical Trial Evaluation of Medical Devices

This article briefly discusses a widely concerned issue, the literature search problem in the clinical trial evaluation process of medical devices.
It must be recognized that literature search needs to cover two types of data:
Regarding medicine The clinical use of therapeutic equipment or its equivalent Bed data
Data directly related to advanced technologies related to equipment and/or equivalent devices, benchmark devices, and similar devices and technologies, as well as medical services available for the intended patient population Data on treatment selection.
If the manufacturer has their own equipment Bed data, this is a definite benefit. Literature and data can be reviewed together for consistent evaluation and comprehensive analysis.
According to section MDCG2020-13D: "Clinical trial evaluation of medical devices should clearly state the selection criteria required by applicable regulations. CERs should distinguish between two types of data (the device being evaluated or equivalent, advanced technology, or alternative treatment options). If these data are unrelated to any of the above, provide the reasons for their inclusion.
The purpose of literature search is to identify published scientific papers that are relevant to medicine The safety of medical equipment There are effective conclusions regarding the integrity, performance, clinical trial benefits of medical devices, and new equipment conditions. Literature retrieval should be accurately, thoroughly, and systematically documented.
The selection of literature should be objective and reasonable, including all favorable and unfavorable information.
Therefore, when considering writing a literature search plan, it should be kept in mind that the selected paper should reflect the intended use of the equipment.
Literature search screening should include:
Research question
The database to be used
The terminology to be used
Inclusion/exclusion criteria
Search methods for literature
How to ensure data integrity
How to evaluate each data source and its correlation with the devices involved
How to analyze and process data
For more details on this, please refer to Appendix A5 in MEDDEV2.7/1Rev. 4.
About the database
Based on the research question and the type of evidence required, some databases can be selected.
The revised Annex 4 of MEDDEV2.7/1 suggests establishing the following database:
PubMed/Medicine: A solid baseline for initiating research
EMBASE: Provides information on medical practices used in Europe Complete information on medical equipment and therapy
In Cochrane Central Trial Registry: Provides complete information on European trials
Medline (PubMed) and EMBASE are leading The first literature database, Cochrane, is the primary choice for controlled trials.
Regarding search terms
The search term is generally the product name or its indication, or a combination of both. However, a good approach is to combine them using logical operators. There are three main operators and, OR, and not, and using them allows you to combine search terms in a specific way to expand or shrink your results. Quotation marks and parentheses are also useful tools for improving the quality of the search process.
Please always remember that the literature search protocol must be established correctly and well, as it constitutes a critical step The basis for other steps in the bed assessment process.
Shenzhen Ruienni Medical Device Management Consulting Co., Ltd. can conduct systematic literature search and review in accordance with the MDR Regulation (EU) 2017/745. Our team can design a comprehensive literature search protocol and complete documentation for literature screening and data extraction processes. We can assist your new doctor The clinical application of therapeutic equipment is obtained from the perspective of literature Bed evidence to create documents that comply with MDR.