Current Quality Management Situation And Supervision Countermeasure Study On Medical Device Enterprises In Xuhui District

Medical devices, a significant tool in disease diagonosis and treatment, have been widely applied in disease treatment, and their qualities have a great influence on clinical diagnosis and treatment. Medical devices marketing enterprises are connections between manufacturers and medical institutions, which are responsible for maintaining, transportation and after sale service of medical devices. In developed countries, the quality contolling of medical devices was mainly focused on production permission of manufacturers and market admittance of products, and medical devices were transported directly form manufacturers to hospitals by logistics companies. In China, medical devices market was divided to parts based on regions by manufacturers, and products were deliveried to hospitals by different agents. However, these medical devices marketing companies were numerous and commonly of small scale, and weak in quality management, which brought risks for medical devices use and consumption. Nowadays, the license permission and supervision of medical devices marketing companies was maily based on "Regulations for the Supervision and Administration of Medical Device" promulgated in the year 2000, "Administrative License Law" and "Medical Device Distribution Enterprise License Management Approach" enacted 2004, and mainly conducted according to "Inspection and acceptance criteria for Medical Device Enterprises in Shanghai (in trial) "and other normative documents. The acceptance criteria were mainly focused on personnel, facilities, quality management systems, procurement, acceptance, storage, transportation sale and after sale service.ObjectiveThis article studied the the status of quality management of medical equipment marketing enterprises in Xuhui District through scene investigation, and searched for weak segments and key problems in quality management. This article aimed to provide necessary suggestions to strengthen medical equipment enterprises governance and improve the medical device management quality by analysising reasons and measures through interviews with key insiders.ResultsComparing large scale medical equipment marketing enterprises with medium and small ones, and comparing agent managementing enterprises with hospital distributing ones in structual factors including presence of quality managers and facilities, there was no significant difference. However, large scale medical equipment marketing enterprises were obviously better than medium and small ones, and agent managementing enterprises was much better than hospital distributing ones comparing them in process aspects, including implementation of quality management systems, duty perform of quality managers, product licence auditing, warehouse entering check, warehouse exiting check, sold notes, traceability management, after sale service, quality tracking, and practitioners training. Large scale in vitro diagnostic reagents marketing enterprises were obviously better than medium and small ones, and agent managementing enterprises was much better than hospital distributing ones comparing them in cold chain management, process aspects. Retail chain enterprises marketing corneal contact lens were apparently better than independent enterprises in process aspects.SuggestionsThis study found that problem and deficiency in quanlity management was common in medical device marketing enterprises in Xuhui district, including quality management despise of leaders, ineffective quality management systems, absence of quality managers, incomplete record of management information and lack of staff training. And supervision from the government was also faced with problems including relevant laws and regulations being rudimentary, supervision being weak and partial. Thus this article puts forward several management approaches to the government including perfecting the relevant laws and regulations, strengthening supervision force, implementing certification management, innovating regulatory approach, strengthening propaganda and training, enhancing quality management and self-discipline awareness of medical device marketing enterprises, and reinforcing the role of industrial association.