Problems and Considerations in the Operation of Blood Station Medical Device Clinical Trial Institutions

doi:10.3969/j.issn.1671-2587.2024.02.004

JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE ›› 2024, Vol. 26 ›› Issue (2): 173-179.DOI: 10.3969/j.issn.1671-2587.2024.02.004

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Problems and Considerations in the Operation of Blood Station Medical Device Clinical Trial Institutions

BAO Jingjing, DONG Ruiping, HAN Wenping, et al

Received:2023-12-11 Online:2024-04-20 Published:2024-04-23

Abstract

CLC Number:

R197

BAO Jingjing, DONG Ruiping, HAN Wenping, et al. Problems and Considerations in the Operation of Blood Station Medical Device Clinical Trial Institutions[J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2024, 26(2): 173-179.

References

[1] 国家食品药品监督管理总局.国家卫生和计划生育委员会.医疗器械临床试验机构条件和备案管理办法(2017年第145号)[EB/OL].(2017-11-24)[2024-3-12].https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20171124123401917.html.
[2] 国家药品监督管理局.医疗器械临床试验质量管理规范(2022年第28号)[EB/OL].(2022-03-31)[2024-3-12].https://www.nmpa.gov.cn/xxgk/fgwj/xzhgfxwj/20220331144903101.html.
[3] 国家药品监督管理局.医疗器械临床试验机构备案受理条件[DB/OL].[2024-3-12].https://zwfw.nmpa.gov.cn/web/taskview/11100000MB0341032Y100207202100001.
[4] RAMALHINHO A C,CASTELO-BRANCO M.Prepara-tion of an academic clinical trial[J].Methods Mol Biol,2021,2197:317-330.
[5] FARIS O,SHUREN J.An FDA viewpoint on unique considerations for medical-device clinical trials[J].N Engl J Med,2017,376(14):1350-1357.
[6] 薛雅峰,潘梦蕖.医疗器械临床试验中存在的问题与建议[J].中文科技期刊数据库(全文版)医药卫生,2022,8(12):231-233.
[7] 张莹莹,李晶,李明,等.机构备案制下临床试验工作开展的几点思考[J].中国新药杂志,2022,31(6):586-589.
[8] 闵玥,刘斌,李铮,等.医疗器械临床试验审批产品目录调整的思考[J].中国药事,2021,35(1):24-28.
[9] 李佳,韩祺,王琪,等.医疗器械临床试验监督抽查问题分析与探讨[J].中国新药与临床杂志,2021,40(2):109-112.
[10] 深圳市血液中心.深圳市血液中心医疗器械临床试验机构成功备案[EB/OL].https://csbt.org.cn/plus/view.php?aid=4235.
[11] 潘辛梅,李明红,谢江川,等.医疗器械临床试验中发现的问题及改进措施[J].医疗卫生装备,2021,42(6):75-78.
[12] 潘辛梅,谢林利,马攀,等.新版《医疗器械临床试验质量管理规范》要点解读与思考[J].中国医疗设备,2023,38(4):119-123.
[13] MARQUIS-GRAVEL G,ROE M T,TURAKHIA M P,et al.Technology-enabled clinical trials:transforming medical evidence generation[J].Circulation,2019,140(17):1426-1436.
[14] 医疗器械临床试验机构备案管理信息系统[DB/OL]https://beian.cfdi.org.cn/CTMDS/apps/pub/ylqxPublic1.jsp.
[15] SINGH D,AGUSTI A,ANZUETO A,et al.Global Strategy for the Diagnosis,Management,and Prevention of Chronic Obstructive Lung Disease:the GOLD science committee report 2019[J].Eur Respir J,2019,53(5):1900164.
[16] HE T,GONG L.Clinical effect of microneedle injection combined with blood transfusion in the treatment of severe Anemia complicated with vitiligo under regenerative medical technology[J].Biomed Res Int,2022,2022:7117627.
[17] MODRALL J G,ZHU H,WEAVER F A.Clinical predictors of blood pressure response after renal artery stenting[J].J Vasc Surg,2020,72(4):1269-1275.
[18] HOSSEINPOUR S,GAUDIN A,PETERS O A.A critical analysis of research methods and experimental models to study biocompatibility of endodontic materials[J].Int Endod J,2022,55(Suppl 2):346-369.
[19] CARDEN L,OLADAPO B.An ethical risk management approach for medical devices[J].Risk Manag Healthc Policy,2021,14:2311-2318.
[20] 王瓅珏,宋超,饶慧瑛.医院医疗器械临床试验数据核查中常见问题及改进措施[J].中华医学科研管理杂志,2022,35(1):31-35.
[21] 周健平,叶颖,王一,等.医疗器械临床试验质量管理体系的探索[J].中华医学科研管理杂志,2021,34(2):157-160.
[22] 张晓燕,武丽,韩安轲,等.六西格玛管理法在医疗器械临床试验质量控制中的应用[J].医疗装备,2023,36(3):50-53.
[23] 段世梅,仲志真.第二类创新医疗器械审批现状及监管的几点思考[J].中国医疗器械杂志,2023,47(1):80-82.
[24] SHIN Y,KIM K W,LEE A J,et al.A good practice-compliant clinical trial imaging management system for multicenter clinical trials:development and validation study[J].JMIR Med Inform,2019,7(3):e14310.
[25] 张正付,王佳楠.医疗器械临床试验数据真实性和完整性的监督检查[J].中国临床药理学与治疗学,2019,24(10):1081-1084.
[26] TUDAN C.Good clinical practices in the bioanalytical laboratory[J].Bioanalysis,2023,15(22):1381-1388.
[27] VAN DER STORM S L,JANSEN M,MEIJER H A W,et al.Apps in healthcare and medical research;European legislation and practical tips every healthcare provider should know[J].Int J Med Inform,2023,177:105141.
[28] VOGESER M.IVDR and diagnostic application of mass spectrometry in the European Union[J].J Mass Spectrom Adv Clin Lab,2021,19:32-33.
[29] ZHANG B,SHANKARA S B,GUO J,et al.Pivotal clinical trials with patient-reported outcome measures in premarket approval applications for high-risk medical devices from 2005 to 2018:review,examples,and regulatory considerations[J].Contemp Clin Trials,2022,116:106757.
[30] 国家药品监督管理局医疗器械技术审评中心发布《关于“医疗器械临床评价” 协调项目成果文件草案公开征求意见的通知》[J].中国医院建筑与装备,2019,20(5):16.
[31] IWAMOTO S,CAVANAUGH K,MALONE M,et al.Global medical device clinical trials involving both the United States and Japan:key considerations for development,regulatory approval,and conduct[J].Cardiovasc Revasc Med,2023,52:67-74.
[32] JIANG J,HUANG S,XIA H F,et al.The landscape of acute pancreatitis trials registered in ClinicalTrials.gov:a cross-sectional study[J].Pancreas,2022,51(5):445-451.
[33] KIM J Y,NAM Y,RIM Y A,et al.Review of the current trends in clinical trials involving induced pluripotent stem cells[J].Stem Cell Rev Rep,2022,18(1):142-154.
[34] VAN DEUTEKOM H W M,HAITJEMA S.Recommendat
ions for IVDR compliant in-house software development in clinical practice:a how-to paper with three use cases[J].Clin Chem Lab Med,2022,60(7):982-988.
[35] STERGIOPOULOS S,GETZ K A,BLAZYNSKI C.Evaluating the completeness of ClinicalTrials.gov[J].Ther Innov Regul Sci,2019,53(3):307-317.

Problems and Considerations in the Operation of Blood Station Medical Device Clinical Trial Institutions

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[1]	. [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2021, 23(6): 750-755.
[2]	HE Zhi-chun, LIN Jun-jie, XU Bei, et al. Practice and Discussion on Application of Performance Excellence Model in Blood Bank Management [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2021, 23(6): 756-759.
[3]	. [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2021, 23(6): 811-816.
[4]	. [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2021, 23(1): 10-12.
[5]	. [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(5): 454-457.
[6]	. [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(5): 470-472.
[7]	LIU Li, MA Chun-ya, PAN Xue, et al.. Clinical Blood Use Characteristics in a Tertiary Hospital in Beijing on the Novel Coronavirous Pneumonia Outbreak [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(4): 354-357.
[8]	. [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(4): 376-379.
[9]	LU Xiao-jun, ZHANG Li-bo, WANG Hui, et al.. The Practice and Retrospect of Nanjing Blood Donation Regulation Legislation [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(4): 394-397.
[10]	WANG Jin, QIU Yan, CUI Shuang, et al.. Application of Traceability Audit in Internal Audit Quality of Blood Collection and Supply Organization [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(4): 405-407.
[11]	YE Sheng, SHEN Yan, CHEN Jin, et al. Reengineering of Apheresis Donation Site and Workflow during COVID-19 Epidemic [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(3): 241-245.
[12]	Chinese Society of Blood Transfusion Clinical Transfusion Management Committee. Investigation and Analysis of Biosafety Protection of Blood Transfusion Departments (Blood Banks) in 2 309 Hospitals during the Epidemic Situation of Novel Coronavirus Pneumonia [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(3): 249-252.
[13]	YING Shang-yun, ZHAO Yi-lun, YUAN Yong, et al. Strategies for the Prevention and Control of Emergency Group Blood Donation Sites during the COVID-19 Pandemic [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(3): 253-258.
[14]	WANG Zheng-yang, SU Jian, CHEN Jiang-tian, et al. Analysis and Countermeasure Research on Performance Management of Blood Services in China [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(3): 285-290.
[15]	CHEN Jiang-tian, YU Li, HAN Wen-juan, et al. The Dilemma and Countermeasures of Human Resource Allocation in Blood Collection and Supply Institutions [J]. JOURNAL OF CLINICAL TRANSFUSION AND LABORATORY MEDICINE, 2020, 22(2): 135-138.