真实世界数据在医疗器械上市后监测中的应用进展

doi:10.19803/j.1672-8629.2022.03.01

摘要/Abstract

摘要： 目的梳理总结真实世界数据在医疗器械上市后监测中的应用进展,为医疗器械监督管理部门提供监管依据。方法从中国、美国和欧盟监管机构官网检索相关政策法规文件,同时检索国内外相关文献。结果各国监管机构相继发布并一定程度更新了真实世界数据相关指南,唯一器械标识、通用数据模型、分布式健康数据网络等技术的发展有助于将多个数据源链接形成规模更大的数据库,自然语言处理技术则推动了电子病历/健康数据在上市后监测中的应用,越来越多的登记数据库,以及数字健康、可穿戴器械自身记录的数据均为上市后监测提供了有别于传统不良事件数据库的数据源,而安全信号自动监测技术则提高了医疗器械上市后监测的效率和及时性。结论可用真实世界数据源日益增加和自动监测技术的发展推动真实世界数据在医疗器械上市后监测中的应用。

关键词: 真实世界数据, 医疗器械, 上市后监测, 真实世界证据, 法规, 登记数据, 主动监测

Abstract: Objective To summarize the progress of applying real-world data in medical device post-market surveillance, so as to provide supervision basis for medical device supervision and management department. Methods Relevant regulation and guidance documents were searched on the NMPA, FDA and EU official website, and relevant literatures were also searched. Results Regulatory agencies from different countries successively issued and updated the guidelines for the application of real-world data. The development of the technologies, such as unique device identification, common data models, and distributed health data networks, helped link multiple data sources to form a larger database. Natural language processing technology also promoted the application of electronic medical records/health data in post-market surveillance. More and more registry data, as well as the data recorded by digital health and wearable devices, provided post-market surveillance extra data source that was different from traditional databases for collecting adverse events. The algorithms to detect safety signal automatically improved the efficiency and immediacy of the medical device post-market surveillance. Conclusion The increasing availability of real-world data sources and the development of automatic detection technologies have promoted the application of real-world data in post-market monitoring of medical devices.

Key words: real-world data, medical device, post-market surveillance, real-world evidence, regulations, registry data, automatic detection

中图分类号:

R955

滕颖影, 李柴全, 胥洋, 唐迅, 高培. 真实世界数据在医疗器械上市后监测中的应用进展[J]. 中国药物警戒, 2022, 19(3): 233-238.

TENG Yingying, LI Chaiquan, XU Yang, TANG Xun, GAO Pei. Progress in the application of real-world data in post-market surveillance of medical devices[J]. Chinese Journal of Pharmacovigilance, 2022, 19(3): 233-238.

参考文献

[1] ZHAO Y, ZHAO YF, ZHENG LJ, et al.Medical device vigilance systems in European Union[J]. Chinese Journal of Pharmacovigi-lance(中国药物警戒), 2021, 18(6): 566-569.
[2] National Medical Product Administration. Technical guidance on applying real-world data in medical device clinical evaluation[EB/OL]. (2020-11-26)[2021-12-17]. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20201126090030150.html.
[3] U.S.FDA. Use of real-world evidence to support regulatory decision-making for medical devices[EB/OL]. (2017-08-31) [2021-12-17] . https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-real-world-evidence-support-regulatory-decision-making-medical-devices.
[4] WANG LL, YANG Y, WANG SL.The application and enlightenment of US FDA sentinel system[J]. Chinese Journal of Pharmacovigilance(中国药物警戒), 2019, 16(2): 81-87.
[5] CHEN JL, YANG YJ, HUANG JH, et al.Incidence of coronary heart disease thrombosis after drug-eluting stent placement in the real world[J]. Chinese Journal of Cardiology(中华心血管病杂志), 2007, 35: 1133-1135.
[6] HAN JC, ZHU WZ, XU J, et al.Percutaneous internal fixation of hollow screw Ti-nails in treatment of femoral neck fracture: curative effect and hostresponse in a follow-up analysis of 57 cases[J]. Journal of Clinical Rehabilitative Tissue Engineering Research(中国组织工程研究与临床康复), 2007, 11(26): 5242-5243.
[7] YIN LQ, LI ZZ, ZHANG JM, et al.Drug eiuting stent impiantation for bifurcation coronary artery disease: nine-month angiographic fellow-up clinical outcome[J]. China Medical Device Information(中国医疗器械信息), 2008, 14(3): 31-33.
[8] CHEN JL, HUANG JH, YANG YJ, et al.Comparison of late stent thrombosis rate alter different drug-eluting stents implantation in patients with coronary artery disease[J]. Chinese Circulation Journal(中国循环杂志), 2009, 24(6): 406-409.
[9] ZHANG L.Follow-up study of drug-eluting stent implantation for unprotected left main disease[D]. Fudan University, 2009.
[10] XIAO DG, MA Y, LIU S.Comparative analysis of long-term effects of sirolimus-eluting stent and bare metal stent in treatment of coronary heart disease[J]. China Medical Device Information(中国医疗器械信息), 2016, 22(8): 74-75.
[11] LI XH, ZHAI W, MA N, et al.Prospective study of bone plate event in Beijing[J]. China Medical Device Information(中国医疗器械信息), 2017, 23(17): 14-17, 37.
[12] CHEN HG, LU J, FU X, et al.The application of remote monitoring in the follow-up of patients undergoing dual-chamber pacemaker implantation[J]. China Medical Device Information(中国医疗器械信息), 2018, 24(11): 30-131, 140.
[13] ROBERTS PR, NICOLAS C, SAMADI FA, et al.A leadless pacemaker in the real-world setting: the micra transcatheter pacing system post-approval registry[J]. Heart Rhythm, 2017, 14(9): 1375-1379.
[14] FALK V, WOHRLE J, HILDICK-SMITH D, et al.Safety and efficacy of a repositionable and fully retrievable aortic valve used in routine clinical practice: the RESPOND Study[J]. Eur Heart J, 2017, 38(45): 3359-3366.
[15] NARDUCCI ML, MAURO B, ERNESTO A, et al.Appropriate implantable cardioverter-defibrillator interventions in cardiac resynchronization therapy-defibrillator (CRT-D) patients undergoing device replacement: time to downgrade from CRT-D to CRT-pacemaker? Insights from real-world clinical practice in the DECODE CRT-D analysis[J]. Europace, 2018, 20(9): 1475-1483.
[16] FROMMEYER G, ANDRESEN D, INCE H, et al.Can we rely on Danish? real-world data on patients with nonischemic cardiomyopathy from the German device registry[J]. Heart Vessels, 2019, 34(7): 1196-1202.
[17] BAI Y, XIN X, DUENNINGER E, et al.Real-world survival data of device-related thrombus following left atrial appendage closure: 4-year experience from a single center[J]. Heart Vessels, 2019, 34(8): 1360-1369.
[18] BRINZEU A, CUNY E, FONTAINE D, et al.Spinal cord stimulation for chronic refractory pain: Long-term effectiveness and safety data from a multicentre registry[J]. Eur J Pain, 2019, 23(5): 1031-1044.
[19] CHATZANTONIS G, CHATZANTONIS G, FINDEISEN H, et al.Real-world analysis of a biolimus A9 polymer-free drug-coated stent with very short dual antiplatelet therapy in patients at high bleeding risk[J]. Herz, 2021, 46(3): 242-249.
[20] BEDOGNI F, TESTA L, RUBBIO AP, et al.Real world safety and efficacy of transcatheter mitral valve repair with MitraClip. Thirty-day results from the Italian Society of Interventional Cardiology (GIse) Registry Of Transcatheter Treatment of Mitral Valve RegurgitaTiOn (GIOTTO)[J]. Cardiovasc Revasc Med, 2020, 21(9): 1057-1062.
[21] U.S.FDA. Examples of real-world evidence (RWE) used in medical device regulatory decisions[EB/OL].(2021-03) [2021-09-05]. https://www.fda.gov/media/146258/download.
[22] WANG SF, NING Y, LI LM.Experience and challenge on interoperability of big data in health care[J]. Chinese Journal of Epidemiology(中华流行病学杂志), 2020, 41(3): 303-309.
[23] BRANCH-ELLIMAN W, STRYMISH J, KUDESIAET V, et al.Natural language processing for real-time catheter-associated urinary tract infection surveillance: results of a pilot implementation trial[J]. Infect Control Hosp Epidemiol, 2015, 36(9): 1004-1010.
[24] WILCOX MA, COPPOLA D, BAILEY N.Risperdal (®) CONSTA (®) needle detachment. incidence rates before and after kit redesign: a retrospective study using electronic health records and natural language processing in the department of veterans affairs[J]. Neurol Ther, 2019, 8(1): 95-108.
[25] CALLAHAN A, JASON AF, CHRISTOPHER RE, et al.Medical device surveillance with electronic health records[J]. NPJ Digit Med, 2019, 2: 94.
[26] BIOMET Z. Zimmer biomet and canary medical announce FDA De Novo classification grant and authorization to market the world's first and only smart knee implant[EB/OL]. (2021-08-30)[2021-11-15]. https://www.multivu.com/players/English/8896551-zimmer-biomet-fda-marketing-authorization-persona-iq-smart-knee-implant/.
[27] MAJITHIA A, MATHENY ME, PAULUS JK, et al.Comparative safety of aspiration thrombectomy catheters utilizing prospective, active surveillance of the NCDR CathPCI registry[J]. Circ Cardiovasc Qual Outcomes, 2019, 12(2): e004666.
[28] KOCKERLING F, SIMON T, HUKAUF M, et al.The importance of registries in the postmarketing surveillance of surgical meshes[J]. Ann Surg, 2018, 268(6): 1097-1104.
[29] MARO JC, HOLMES JH, STROM BL, et al.Design of a national distributed health data network[J]. Academia and Clinic, 2009, 151(5): 341-344.
[30] BANERJEE S, CAFRI G, ISAACS AJ, et al.A distributed health data network analysis of survival outcomes: the international consortium of orthopaedic registries perspective[J]. J Bone Joint Surg Am, 2014, 96(Suppl 1): 7-11.
[31] RESNIC FS, MAJITHIA A, MARINAC-DABIC D, et al.Registry-based prospective, active surveillance of medical-device safety[J]. N Engl J Med, 2017, 376(6): 526-535.
[32] ZHANG QT, CHEN QY.The plan of implementing the unique identification code of patients[J]. Journal of North Pharmacy(北方药学), 2011, 8(9): 96-97.
[33] DROZDA JP, ROACH J, FORSYTHD T, et al.Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration[J]. J Am Med Inform Assoc, 2018, 25(2): 111-120.
[34] JIANG G, DHRUVA SS, CHEN JJ, et al.Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: a fit-for-purpose informatics analysis report[J]. J Am Med Inform Assoc, 2021, 28(10): 2241-2250.
[35] CHUNG G, ETTER K, YOO A.Medical device active surveillance of spontaneous reports: a literature review of signal detection methods[J]. Pharmacoepidemiol Drug Saf, 2020, 29(4): 369-379.
[36] PANE J, VERHAMME KMC, VILLEGAS D, et al.Challenges associated with the safety signal detection process for medical devices[J]. Med Devices (Auckl), 2021, 14: 43-57.
[37] VIDI VD, MATHENY ME, DONNELLY S, et al.An evaluation of a distributed medical device safety surveillance system: the DELTA network study[J]. Contemp Clin Trials, 2011, 32(3): 309-317.
[38] RAJAN PV, HOLTZMAN JN, KESSELHEIM AS, et al.Landscape of cardiovascular device registries in the united states[J]. J Am Heart Assoc, 2019, 8(11): e012756.