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[Research on Reliability Design and Verification of CT Based on Clinical Application Data].

Dongfang Jia1, Wei Jin2, Weiqiang Zhang3

  • 1Shanghai United Imaging Healthcare Co. Ltd., Shanghai, 201800.

Zhongguo Yi Liao Qi Xie Za Zhi = Chinese Journal of Medical Instrumentation
|June 7, 2021
PubMed
Summary

This study translates clinical data from X-ray computed tomography (CT) into product reliability requirements. It establishes a closed-loop method for reliability design and verification using patient tables and data control boards.

Keywords:
CTaccelerated life testreliability designreliability indexreliability test

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Area of Science:

  • Medical Imaging Technology
  • Product Reliability Engineering
  • Clinical Data Analysis

Background:

  • Clinical application data from medical X-ray computed tomography (CT) systems is crucial for understanding real-world performance.
  • Translating this data into actionable product reliability requirements is a significant challenge in medical device development.

Purpose of the Study:

  • To develop a method for transforming clinical application data into product reliability index requirements for medical CT.
  • To demonstrate a closed-loop process from reliability requirements to design and verification using representative components.

Main Methods:

  • Utilized clinical application data from Shanghai Sixth People's Hospital's medical CT systems.
  • Defined reliability index requirements based on failure characteristics and clinical data.
  • Applied the method to mechanical (patient table) and electronic (data control board) components.

Main Results:

  • Established a complete set of closed-loop implementation methods for reliability engineering.
  • Demonstrated the practical application of transforming clinical data into reliability requirements.
  • Provided a framework for reliability design and verification informed by clinical usage.

Conclusions:

  • The proposed method effectively bridges clinical data with product reliability engineering for medical CT.
  • This approach enhances the reliability of medical devices by grounding design in actual clinical performance.
  • The study offers a systematic pathway for improving medical CT product reliability through data-driven insights.