Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (3): 233-238.
DOI: 10.19803/j.1672-8629.2022.03.01
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TENG Yingying1,2, LI Chaiquan1, XU Yang3, TANG Xun1, GAO Pei1,3,*
Received:
2021-11-14
Online:
2022-03-15
Published:
2022-03-16
CLC Number:
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.
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URL: https://www.zgywjj.com/EN/10.19803/j.1672-8629.2022.03.01
[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. |
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