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Medical device databases: a scoping study.

S Price1, R Summers, D Williams

  • 1Research School of Informatics, Loughborough University, UK.

Conference Proceedings : ... Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual Conference
|February 7, 2007
PubMed
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Existing medical device databases lack consistent information and evaluation. A comprehensive database requires a policy for validating information to meet diverse user needs, including patients and healthcare professionals.

Area of Science:

  • Medical device regulation and information management.
  • Health informatics and data governance.

Background:

  • Medical device databases are crucial for tracking product, business, and regulatory information.
  • Current databases exhibit inconsistencies in data coverage and lack evidence of applied evaluation criteria.

Purpose of the Study:

  • To evaluate the scope and quality of existing medical device databases.
  • To identify requirements for a comprehensive medical device database.

Main Methods:

  • Complex search strategies were employed to identify and categorize medical device databases.
  • A qualitative evaluation was conducted on the identified databases.

Main Results:

  • Databases fall into Product, Business, and Regulation categories.

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  • Significant issues include inconsistent information levels and a lack of documented evaluation.
  • A need exists for a comprehensive database catering to diverse stakeholders.

    • Conclusions:

    • A comprehensive medical device database must address varied stakeholder information needs.
    • Developing a policy for validating information gathering, representation, and retrieval is essential.
    • Improved data validation and accessibility are critical for medical device information systems.