Implementations Of Hospital Medical Equipment Quality Control System

Object: With the development of society and the progress of technology, the advancedmedical equipments such as CT, MR, PET and TOMO are widely applied for clinicaldiagnosis or treatment, which play an important role in research and teaching programs;increasing hospital’s social and economic benefits; supporting the academic activities andbuilding brands for hospitals. Regardless of the quality and safety of medical equipments,the medical accidents injurious to public health even life safety may occur, thus the qualitycontrol (QC) and application safety attach more attentions. Compared with the whole set ofQC system through the production, sale, application and rejection link of medicalequipments established in1960’s abroad, the domestic QC is in its elementary stage in thatfew class AAA hospitals attempt to establish the QC system however device department isin charge of that generally and the related management system is incomplete. This studymade a set of QC system for medical devices to the question of domestic medicalinstitutions: changing the single responsible department to multilevel responsibledepartments for medical device QC, while assure the integrated events management andmaximize the medical safety.Methods: Applying management theory and biomedical engineering principle toinvestigate the domestic hospitals’ operation mode and current QC situation, we understandthe problems such as insufficient emphasis on QC, not well organized institution, outmodedtesting method, lack of professionals, unsystematic management. Our research covers theaspects of organization building, team training, clinical applications, accident reporting,introduce argument, purchase, acceptance, service, annual quality assurance, ejection,testing standard, experimental filed design, informational management, et al. We attempt toestablish the total-staff involved, total factor, whole lifecycle medical equipment QAsystem basis on experimental stage of one class AAA hospital in Beijing. Results: A set of3-level medical equipment QC system was established and acceptedby experts of PLA after5years’ operation and improvement including of making QCstandard, importing and training professionals, clinical applications, monitoring accidents,acceptance testing, post-maintain testing, pre-rejection testing, annual quality assurance,developing QC information management system, improve archive management, settingexperimental field construction standard, et al. The acceptance rate of some medicalequipments increases form less than50%in2008to over95%by far, and equipments typesnumber increases from15to22, and the number of equipments which was tested becomes80%of all equipments of hospital.Conclusion: The medical equipment QC is an important role of hospital’s routinetasks. By setting up complete medical equipments QC system and by combining dailymanagement with engineering technology methods, the medical equipments managementchanged from coarse type to fine type, which may find and prevent potential accidents suchas electrotome kills and hyperbaric oxygen chamber (HBOC) burst thus assure theapplications quality and safety of medical equipments. The equipment quality and safetyhave been institutionalized and routinized. The engineer technology guided activemanagement strategy and dynamic whole life monitoring assured the applications andsafety of medical equipment thus assure discipline development and hospital brand.