Laboratory Information Management System For Medical Devices Testing Center

This paper is based on the related regulations in the 《Regulations for the Supervisionand Administration of Medical Devices》（Decree of the State Council No.276）,《SomeAdvices of CFDA about Strengthening Informatization Construction of Drug Supervision andAdministration》(China Drug Administration Office [2000] No.3) and《Regulations forNational Medical Devices Quality Supervision Sampling Inspection (Trial)》(CFDA Market[2006] No.463). The Working Principles that supervision is the core and supervision,assistance and promotion are integrated, modern information science and technologies,advanced instruments and scientific management are implemented to provide strong supportfor medical devices inspection. The office efficiency is greatly improved and the goodconditions to honest law enforcement and standardizing the administrative behavior arecreated by informatization construction and resulting advanced administration model.Strengthening informatization construction of medical devices inspection and realizingscientific standardized supervision and administration are urgently needed to ensure the safetyand efficiency of medical devices, to prompt medical devices industry healthy developmentand to gradually improve “supervised by law, scientific and justice, honest and efficient,behavior regularized” administration system to medical devices.The medical device products, Integrated with mechanics, electronics, optics, acoustics,materials and Biochemistry, have many varieties, models and specifications and thus result inthe standards of medical device products having many categories and many correspondingtesting instruments having different types and models. Therefore traditional working mode fordaily medical devices inspection has not adapted to the requirement of modern administration.Modern information technologies will help medical devices inspection to be animportant method and to provide scientific powerful legal evidence to medical devicessupervision. Shanxi Province Medical Devices Testing Center is in charge of reusable medicaldevices inspection and provides professional, standard, exclusive and authoritative testingresults with which the strong legal support and guarantee to medical devices supervision isprovided in Shanxi province. The development and implement of laboratory information management System forMedical Devices Testing Center, the specific application of modern information technologiesin the field of medical devices inspection, results in advanced administration model andrealizes scientific standard supervision and administration. A close, coordinated, reliable andsimple administration system is set up with the above system and all personnel have clearduty and Jurisdiction. All specific affairs have been responsible by specific personnel and thestates of all samples can be tracked. The inspections have related basic data and put an end toexcuses and wrangles. The repeated data recording is avoided and make sure to correct timelyresponse. The effects to testing results because of individual mistakes are reduced. The testingoperation flows are regularized and the scientific correct testing results are obtained. Theresources of testing center are effective circulation and share. Thus working efficiency isimproved, effective management is realized, responsibility is clear, cost is reduced and everymanagement links are combined organically. The working state of testing center can be fullyknown by the administrator. The scientific medical devices testing results are provided andthe safety prevention and control of reusable medical devices is strengthened with thesoftware. A new direction for informatization construction being used in the medical devicesinspection is put forward.