Safety Evaluation of Surgical Instruments

  • Yunwei Xu

    Student thesis: Doctoral ThesisDoctor of Philosophy


    Spurred by recent press reports and other concerns this thesis focuses on the quality of surgical instruments. The current situation is reviewed by considering the regulatory framework and by investigating the quality of newly purchased instruments. A range of test protocols based on British Standards and best practices from industry were developed. These were designed to be practical in the real world situation and a user-friendly database was built to collate all the relevant data and inform the Supply Chain.

    The conditions experienced by instruments during their lifetime in the health care environment, especially in cleaning and disinfection were studied and as many instruments implicated in Incidents as possible investigated to understand the possible root causes of failure.

    During this work the importance and debate over surface finish, passivation and disinfection processes became apparent and research was carried out into the effect on wettability and drying mechanism of passivation and repeated disinfection cycles on various typical surface finishes. This concentrated on the environment within the health service unlike other studies which have been concerned with more aggressive industrial situations.

    Standards and Procedures on the care of instruments have been established in order to improve the current management of surgical instruments and to ensure that they are and remain fit for purpose.
    Date of Award2017
    Original languageEnglish
    SupervisorZhihong Huang (Supervisor) & George Corner (Supervisor)


    • Surgical instrument
    • Quality assurance

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