Application and effectiveness of SPD management of consumables and reagents in a public hospital / 中华医院管理杂志

In the context of high-quality development in medical institutions, the supply-processing-distribution(SPD) management mode has gradually been widely applied. The authors described in detail the procurement, supply, inventory, distribution, and settlement management of medical consumables and in vitro diagnostic reagents in a certain hospital under the SPD mode. It was found that SPD was conducive to strengthening the supervision of medical consumables and in vitro diagnostic reagents in the hospital, ensuring quality and safety of use, reducing hospital operating costs, and improving hospital′s competitiveness. However, attention should be paid to preventing data security risks, strengthening operational management, and improving the cost-benefit analysis of in vitro diagnostic reagents.

Research on quality evaluation and improvement of in vitro diagnostic reagent supply chain based on zero inventory target / 中国医学装备

Objective:To establish the objective of zero inventory management of in vitro diagnostic reagents,to evaluate the quality of supply chain,and to improve the existing problems in the supply of reagents.Methods:The problems existing in the management of in vitro diagnostic reagents were analyzed from the aspects of inventory,supply efficiency and product quality,and the management system of hospital operation,management quality and patient benefit optimization was established,and the zero-inventory management path and quality evaluation model were constructed.85 models of 21 types of in vitro diagnostic reagents purchased by Jiangsu Subei People's Hospital from January 2020 to March 2023 were selected.According to different supply chain quality management methods,on-demand inventory management mode(referred to as mode 1)and zero inventory management mode(referred to as mode 2)were adopted respectively.The demand procurement,inventory management and clinical use effects of the two management modes were compared.Results:The reagent procurement demand compliance rate,supply capacity high-quality quality rate and clinical use matching rate of mode 2 were(93.35±3.62)%,(94.87±2.63)% and(96.08±2.31)%,respectively,which were higher than those of mode 1,the difference was statistically significant(Z=2.489,2.836,2.838,P<0.05).The number of cases of long-term overstocking of products,substandard environment and untimely information in mode 2 were(2.92±2.54)cases,(2.83±1.59)cases and(5.58±3.12)cases,respectively,which were lower than those in mode 1,the difference was statistically significant(Z=2.959,3.037,3.703,P<0.05).The satisfaction of clinical departments,medical technology departments and procurement center with the supply,distribution and information communication of in vitro diagnostic reagents in mode 2 were 97.8% and 93.3%,97.0% and 87.9%,100% and 84.6%,respectively,which were higher than those in mode 1,the difference was statistically significant(x2clinical departments=5.428,6.133,x2medical technology departments=3.958,3.937,x2procurement center=5.159,4.996,P<0.05).Conclusion:The zero inventory management model can improve the standardization of in vitro diagnostic reagent demand procurement,reduce the incidence of backlog failure in inventory management,and improve the quality of clinical supply services.

A Brief Discussion on the in Vitro Diagnostic Reagent Inspection Practice of Self-examination Management Regulations for Medical Device Registration / 中国医疗器械杂志

On October 21, 2021, the National Medical Products Administration issued and implemented the Self-examination Management Regulations for Medical Device Registration. The regulations clarify the specific requirements of the registration applicants in the process of self-examination, and put forward detailed requirements from the aspects of self-examination ability, self-examination report, declaration materials and responsibility requirements, so as to ensure the orderly development of the self-examination of medical device registration. Based on the actual verification work of in vitro diagnostic reagent, this study briefly discussed the understanding of the relevant contents of the regulations, aiming to provide some reference for enterprises and related supervision departments that have the requirement of registered self-examination.

Visualization analysis of microfluidics research status / 生物医学工程学杂志

Microfluidics is the science and technology to manipulate small amounts of fluids in micro/nano-scale space. Multiple modules could be integrated into microfluidic device, and due to its advantages of microminiaturization and controllability, microfluidics has drawn extensive attention since its birth. In this paper, the literature data related to microfluidics research from January 1, 2006 to December 31, 2021 were obtained from Web of Science Core Collection database. CiteSpace 5.8.R3 software was used for bibliometrics analysis, so as to explore the research progress and development trends of microfluidics research at home and abroad. Based on the analysis of 50 129 articles, it could be seen that microfluidics was a hot topic of global concern, and the United States had a certain degree of authority in this field. Massachusetts Institute of Technology and Harvard University not only had a high number of publications, but also had strong influence and extensive cooperation network. Combined with ultrasonic, surface modification and sensor technology, researchers constructed paper-based microfluidic, droplet microfluidic and digital microfluidic platforms, which were applied in the field of immediate diagnosis, nucleic acid and circulating tumor cell analysis of in vitro diagnosis and organ-on-a-chip. China was one of the countries with a high level of research in the field of microfluidics, while the industrialization of high-end products needed to be improved. As people's demand for disease risk prediction and health management increased, promoting microfluidic technological innovation and achievement transformation is of great significance to safeguard people's life and health.

Analysis on the Quality Status of in Vitro Diagnostic Reagents for National Medical Device Supervision and Inspection in 2020 / 中国医疗器械杂志

OBJECTIVE@#This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device.@*METHODS@#This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020.@*RESULTS@#The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance.@*CONCLUSIONS@#It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.

Brief Introduction about New Regulation of EU on IVDR / 中国医疗器械杂志

There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on

Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System / 中国医疗器械杂志

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.

HBV DNA load detected by two domestic fluorescent quantitative PCR reagents: a comparative analysis / 中国输血杂志

【Objective】 To compare the quantitative detection results of two domestic quantitative real-time PCR reagents in HBV-DNA detection. 【Methods】 A total of 306 serum samples form hepatitis B patients were selected for quantitative parallel detection of high-sensitiveity HBV-DNA using domestic reagent A and B, and the difference and consistency of the results were analyzed. 【Results】 1) The yielding rate of reagent A and B was 86.92% and 84.64%, respectively. The regression linear equation was Y=0.984 9x+ 0.154 9, R2=0.945 7, the correlation coefficient r=0.972 5, indicating the results by the two reagents had good correlation. 2) When the concentration was in the range of(20~1 000) IU/mL, the yielding rates of reagent A and B were 39.9% and 37.6%, respectively. 【Conclusion】 Reagent A is more suitable for post-treatment monitoring in patients with OBI and HBeAg(-), but also can be used to detect HBV pathogens in patients before operations or blood transfusions.

Relationship between Reference Interval Establishment and Clinical Evaluation in Quantitative / 中国医疗器械杂志

Reference interval study and clinical evaluation are crucial supportive researches to demonstrate the intended use of quantitative

Analysis of Cut Off Value or Reference Interval of / 中国医疗器械杂志

The cut off value or reference interval is significant in clinical testing and diagnosis. If there is no scientific and reasonable cut off value or reference interval for

Summary of Statistical Methods Commonly Used in Clinical Evaluation of / 中国医疗器械杂志

Referring to relevant normative documents, we summarized the commonly used statistical methods in clinical evaluation of

Analysis of Quality Management of in Vitro Diagnostic Reagent Clinical Trials / 中国医疗器械杂志

Clinical trial is an important step of in vitro diagnostic reagents research and development. Based on the Guiding Principles and the key points of inspect on the spot, combined with the actual work experience, the article focuses on the prominent problems in the whole process of in vitro diagnostic reagent clinical trials. It is helpful to improve the level of hospital drug clinical trial centre and the quality of in vitro diagnostic reagent clinical trials by analyzing the issues.

Analysis of the Development Status of Clinical Pharmacogenomics Based on External Quality Assessment from 2014 to 2019 in China / 中国药房

OBJECTIVE：To provide reference for promoting individualized medication in clinic. METHODS ：Information on external quality assessment （EQA）projects and approved kits for the guidance of chemical drug use were collected from the websites of National Center for Clinical Laboratories （NCCL） and National Medical Products Administration （NMPA） as of December 31，2019. The number of laboratories participating in each evaluation project was count. Taking EQA projects of clopidogrel and warfarin drug metabolism gene polymorphism detection as examples ，who was with the highest participation rate ， the methods and reagent kits of each laboratory were analyzed so as to analyze the current status of the clinical pharmacogenomics （PGx）in China. RESULTS ：The number of PGx genetic test EQA projects conducted by NCCL increased from 3（2014）to 9 （2019）. The total number of participating laboratories was 926 in 2018，and 1 249 in 2019. The number of laboratories of warfarin and clopidogrel drug metabolism gene polymorphism detection increased from 57 to 300.5 for warfarin and from 124 to 374.5 for clopidogrel. The more widely used methods were fluorescent PCR and PCR-chip hybridization. The number of reagent kits currently approved by NMPA was 7 for warfarin and 15 for clopidogrel ，respectively. But some of the laboratories participating in EQA used self-prepared reagents yet. CONCLUSIONS ：The clinical PGx is in its infancy ，and the awareness of laboratories about EQA is improving；the main method was fluorescence PCR ，but the use of self-made reagents in laboratories is still common ，regulations concerning the approval ，use and supervision still need to be further improved.

Analysis of Class II Common Problems in the Registration of / 中国医疗器械杂志

From the perspective of technical review, this paper made statistics on the supplement contents of

Research on the Whole-process Cloud Monitoring Mode of Diagnostic Medical Devices Adverse Events / 中国医疗器械杂志

OBJECTIVE@#To improve the monitoring mode of diagnostic medical devices adverse events.@*METHODS@#By discussing the objective laws of the characteristics, performances and causes of diagnostic medical devices adverse events, the key points of monitoring work were clarified.@*RESULTS@#The whole-process cloud monitoring mode for adverse events of diagnostic medical devices was constructed based on risk management, and the working procedures for the four core links i.e. collection and report, investigation, analysis and evaluation, and controlling were formulated.@*CONCLUSIONS@#The whole-process cloud monitoring mode contributes to improve the monitoring level and efficiency of diagnostic medical devices adverse events in China, so as to strengthen risk control capability and ensure the public can use medical devices safely.

Study on Risk Assessment Model of in Diagnostic Reagent Adverse Events Based on BP Neural Network / 中国医疗器械杂志

OBJECTIVE@#To modify the monitoring process and means of adverse events diagnostic reagents,improve the quantity and quality of adverse events reported ,and reduce the workload of regulatory authorities,eventually ensure the safety and effectiveness of diagnostic reagents.@*METHODS@#The pre-filtering risk assessment system based on BP neural network was used to evaluate the adverse events of diagnostic reagents.According to the evaluation results,the administrative supervision departments took corresponding countermeasures.@*RESULTS@#The BP neural network learned the historical data,and the risk evaluation results of the adverse events were basically consistent with the expert group.@*CONCLUSIONS@#BP neural network can be used to evaluate the risk of adverse events and achieve risk signal aggregation of adverse events.

Discussion on Regulatory Risk of in Vitro Diagnostic Reagents in Use / 中国医疗器械杂志

According to the information of the supervision and inspection of in vitro diagnostic reagents for clinical use, this article analyzed the compliance issues and discussed the methods to solve the problems, to urge medical institutions to reduce the regulatory risk of in vitro diagnostic reagents in use.

The management and application of cold-chain for in vitro diagnostic reagent / 中国医学装备

Objective: To carry out effective management for the cold-chain temperature of in vitro diagnostic reagent so as to provide safe and credible inspection basis for clinical diagnosis and treatment. Methods: The remote control and alarm platform of cold storage and refrigerator were applied to achieve acceptance for temperature control of in vitro diagnostic reagent, and achieve acceptance for temperature and achieve differentiation management for unqualified product. These methods could ensure controllability of temperature for the reagent with requirements of cold-chain. Results: Through the management of cold-chain of in vitro diagnostic reagents, hospital has achieved effective supervising for them, and hospital has concrete record for these reagents in the entire medical process, and all of them were traceability. Therefore, it provide effective guarantee for clinical safety. Conclusion: The support of informatization technique and implementation of management system of hospital can ensure the cold-chain management of entire process is not out of control, and enhance the stability and accuracy of clinical test results and effective guarantee the safety of diagnosis and treatment for hospital.

Methods for determining expiration date of in vitro diagnostic medical device and significance for signing expiration date / 医疗卫生装备

Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.

Methods for determining expiration date of in vitro diagnostic medical device and significance for signing expiration date / 医疗卫生装备

Objective To explore the common methods for determining the expiration rate of the in vitro diagnostic medical device and the significance for signing the expiration date.Methods The methods for determining the expiration date were analyzed based on the features of the in vitro diagnostic medical device and Regulations for Medical Devices Registration and Management.Results The methods estimated the expiration date effectively,while the expiration date had to be monitored and calibrated in time according to risk management principle.Conclusion The safety and efficiency of the in vitro diagnostic medical device are enhanced by signing the expiration date in the technical manual and label.