International Research Focuses of Risk Management of Medical Devices: A Bibliometric Analysis_Chinese Journal of Evidence-Based Medicine

Authors：

 GAO Xiao-yan ¹ , MA Liang ¹ ,  CUI Ze-shi ¹ , LI Chuan-jia ² , LI Su-min ³

1. Center of Laboratory Technology and Experiment Medicine, China Medical University, Shenyang 110001, China;
2. Fourth Hospital Affiliated to China Medical University, Shenyang 110032, China;
3. Department of Finance, China Medical University, Shenyang 110001, China;

Corresponding author：

CUI Ze-shi, Email: labczs@mail.cmu.edu.cn

Keywords：

Medical device; Risk management; Bibliometric analysis; Cluster analysis; High frequency MeSH

DOI：

10.7507/1672-2531.20140118

Video：

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Objective To analyze the current situation and international research focuses on the study of medical device risk management. Methods To retrieve medical device risk management literature information cited from 2002 to 2011 in PubMed such as high-frequency MeSH; analyze current situation and research focuses of medical device risk management by using bibliometrics, bibliographic item co-occurrence matrix builder (BICOMB), and graphical clustering toolkit (gCluto) for quantitative analysis, high-frequency MeSH term papers cluster visualization analysis. Results A total of 7 073 published studies were retrieved, basically suggesting a gradually increasing trend of the number of published papers. The top 3 numbers of first authors' papers referred to three countries: the United States, Britain and Germany, while China ranked twelfth. The top 3 numbers of journal articles referred to the United States, Britain and Holland, while China ranked twenty-second. Twenty journals published more than 50 papers, and all these journals were clinical journals. Thirty-three authors published no less than 5 papers, with the maximum of 18 articles. Totally, there were 124 highfrequency MeSHs. The high-frequency MeSHs were classified into 6 categories by using double cluster analysis: kinds 0 to 4 included risk report, risk analysis, risk assessment and methodology of heart valve prosthesis, coronary stents, peripheral vascular stents, implantable defibrillators and other life support device, surgical repair surgical flaps and minimal invasion surgical device such as laparoscopy; kind 5 focused on safety management, risk control, organization and implementation and other related research based on prevention and control of medical device adverse reaction, medical errors, occupation exposure, and equipment failure. Conclusion The analysis on international literature on medical device risk management basically shows a gradually increasing trend; most studies published in the clinical medicine journals; research focus on risk assessment, safety management and quality improvement in the application such as angioplasty, artificial prosthesis replacement, plastic surgery, minimally invasive surgery and critical care medicine, and radiology diagnosis and treatment; implantable, life-supported invasive and radiological devices as the main research subject; and characteristics include closely combination between medical device risk management and the application of safe and effective, quality improvement systems for clinical diagnosis and treatment.

Citation： GAO Xiao-yan, MA Liang, CUI Ze-shi, LI Chuan-jia, LI Su-min. International Research Focuses of Risk Management of Medical Devices: A Bibliometric Analysis. Chinese Journal of Evidence-Based Medicine, 2014, 14(6): 691-697. doi: 10.7507/1672-2531.20140118 Copy

1.	焦灵利.医疗器械不良事件监测与风险管理.中国医疗器械信息, 2008, 14(12):37-40.
2.	崔佳.基于风险管理的我国医疗器械不良事件监测政策优化理论分析.中国药物警戒, 2009, 6(2):96-99.
3.	方涛.基层医疗器械不良事件监测及风险管理探讨.中国药物警戒, 2009, 6(5):302-304.
4.	Top 10 Health Technology Hazards for 2013. Health Devices, 2012, 41(11):1-25.
5.	欧阳昭连, 池慧, 杨国忠.在用医疗器械风险管理问题及对策研究㈠.中国医疗器械信息, 2007, 13(12):43-47.
6.	程述森, 石应康, 金蓓, 等.医疗器械的风险管理与质量控制.中国循证医学杂志, 2010, 10(6):754-755.
7.	李传佳, 王天旭, 崔泽实.医学装备预防维护在医疗风险管理中作用的探讨.中国医学装备, 2011, 8(6):37-43.
8.	崔雷, 刘伟, 闫雷, 等.文献数据库中书目信息共现挖掘系统的开发.现代图书情报技术, 2008, (8):70-74.
9.	http://glaros.dtc.umn.edu/gkhome/views/cluto.
10.	Sherrard LJ. Protection from whatever they face. Occup Health Saf, 2011, 80(11):14, 16-7.
11.	Sherrard LJ. Those glaring issues. Occup Health Saf, 2011, 80(2):22, 24.
12.	Naylor AR, Gaines PA, Rothwell PM. Who benefits most from intervention for asymptomatic carotid stenosis:patients or professionals? Eur J Vasc Endovasc Surg, 2009, 37(6):625-632.
13.	Naylor AR. Riding on the CREST of a Wave! Eur J Vasc Endovasc Surg, 2011, 39(5):523-526.
14.	Naylor AR. Endarterectomy versus carotid stenting. Br J Surg, 2012, 99(2):149-151.
15.	Moss AJ. Life versus death. Circulation, 2008, 117(15):1912-1913.
16.	Moss AJ. Should everyone with an ejection fraction less than or equal to 30% receive an implantable cardioverter-defibrillator? Everyone with an ejection fraction < or=30% should receive an implantable cardioverter-defibrillator. Circulation, 2005, 111(19): 2537-2549.
17.	Eggebrecht H, Schäfer U, Treede H, et al. Valve-in-valve transcatheter aortic valve implantation fordegenerated bioprosthetic heart valves. JACC Cardiovasc Interv, 2011, 4(11):1218-1227.
18.	Bedogni F, Laudisa ML, Pizzocri S, et al. Transcatheter valve-invalve implantation using Corevalve Revalving System for failed surgical aortic bioprostheses. JACC Cardiovasc Interv, 2011, 4(11): 1228-1234.
19.	Seiffert M, Conradi L, Baldus S, et al. Impact of patient-prosthesis mismatch after transcatheter aortic valve-in-valve implantation in degenerated bioprostheses. J Thorac Cardiovasc Surg, 2012, 143(3): 617-624.
20.	Eggebrecht H, Schäfer U, Treede H, et al. Valve-in-valve transcatheter aortic valve implantation fordegenerated bioprosthetic heart valves. JACC Cardiovasc Interv, 2011, 4(11):1218-1227.
21.	Choi CU, Rha SW, Chen KY, et al. Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimus-eluting stents in patients with acute myocardialinfarction undergoing percutaneous coronary intervention. Circ J, 2009, 73(12):2229-2235.
22.	Williams DO, Abbott JD, Kip KE. DES cover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents:report of the DEScover Registry. Circulation, 2006, 114(20):2154-2162.
23.	Casserly IP. Trans-radial treatment of in-stent restenosis of the superficial femoral artery--the importance of case selection. Catheter Cardiovasc Interv, 2009, 74(3):499.
24.	Duwayri Y, Vallabhaneni R, Kirby JP, et al. Early protection and compression of residual limbs mayimprove and accelerate prosthetic fit:a preliminary study. Ann Vasc Surg, 2012, 26(2):242-249.
25.	Amelot M, Foucault A, Scanu P, et al. Comparison of outcomes in patients with abandoned versus extracted implantable cardioverter defibrillator leads. Arch Cardiovasc Dis, 2011, 104(11):572-577.
26.	Kato TS, Schulze PC, Yang J, et al. Pre-operative and post-operative risk factors associated with neurologic complications in patients with advanced heart failure supported by a left ventricular assist device. J Heart Lung Transplant, 2012, 31(1):1-8.
27.	Sasaki T, Hansford R, Zviman MM, et al. Quantitative assessment of artifacts on cardiac magnetic resonance imaging of patients with pacemakers and implantable cardioverter-defibrillators. Circ Cardiovasc Imaging, 2011, 4(6):662-670.
28.	D'Arpa S, Cordova A, Pignatti M, et al. Freestyle pedicled perforator flaps:safety, prevention of complications, and management based on 85 consecutive cases. Plast Reconstr Surg, 2011, 128(4):892-906.
29.	Ostergard DR. Evidence-based medicine for polypropylene mesh use compared with native tissue vaginal prolapse repair. Urology, 2012, 79(1):12-14.
30.	Sherrard LJ. Guidelines for a quality program. Occup Health Saf, 2008, 77(7):84, 86.
31.	McKinney M. High-tech hazards. Alarm hazards tops ECRI list of health dangers. Mod Healthc, 2011, 41(45):18.
32.	Marchessault L, Hoagland H. Making sense of electrical PPE. Occup Health Saf, 2011, 80(10):34, 36, 38.
33.	王兰明.医疗器械不良事件监测与风险管理浅议.中国药房, 2003, 14(9):516-519.
34.	高小燕, 李素敏, 崔泽实, 等.医学装备风险管理文献的计量研究.中国医学装备, 2013, 10(4):12-14.

1. 焦灵利.医疗器械不良事件监测与风险管理.中国医疗器械信息, 2008, 14(12):37-40.
2. 崔佳.基于风险管理的我国医疗器械不良事件监测政策优化理论分析.中国药物警戒, 2009, 6(2):96-99.
3. 方涛.基层医疗器械不良事件监测及风险管理探讨.中国药物警戒, 2009, 6(5):302-304.
4. Top 10 Health Technology Hazards for 2013. Health Devices, 2012, 41(11):1-25.
5. 欧阳昭连, 池慧, 杨国忠.在用医疗器械风险管理问题及对策研究㈠.中国医疗器械信息, 2007, 13(12):43-47.
6. 程述森, 石应康, 金蓓, 等.医疗器械的风险管理与质量控制.中国循证医学杂志, 2010, 10(6):754-755.
7. 李传佳, 王天旭, 崔泽实.医学装备预防维护在医疗风险管理中作用的探讨.中国医学装备, 2011, 8(6):37-43.
8. 崔雷, 刘伟, 闫雷, 等.文献数据库中书目信息共现挖掘系统的开发.现代图书情报技术, 2008, (8):70-74.
9. http://glaros.dtc.umn.edu/gkhome/views/cluto.
10. Sherrard LJ. Protection from whatever they face. Occup Health Saf, 2011, 80(11):14, 16-7.
11. Sherrard LJ. Those glaring issues. Occup Health Saf, 2011, 80(2):22, 24.
12. Naylor AR, Gaines PA, Rothwell PM. Who benefits most from intervention for asymptomatic carotid stenosis:patients or professionals? Eur J Vasc Endovasc Surg, 2009, 37(6):625-632.
13. Naylor AR. Riding on the CREST of a Wave! Eur J Vasc Endovasc Surg, 2011, 39(5):523-526.
14. Naylor AR. Endarterectomy versus carotid stenting. Br J Surg, 2012, 99(2):149-151.
15. Moss AJ. Life versus death. Circulation, 2008, 117(15):1912-1913.
16. Moss AJ. Should everyone with an ejection fraction less than or equal to 30% receive an implantable cardioverter-defibrillator? Everyone with an ejection fraction < or=30% should receive an implantable cardioverter-defibrillator. Circulation, 2005, 111(19): 2537-2549.
17. Eggebrecht H, Schäfer U, Treede H, et al. Valve-in-valve transcatheter aortic valve implantation fordegenerated bioprosthetic heart valves. JACC Cardiovasc Interv, 2011, 4(11):1218-1227.
18. Bedogni F, Laudisa ML, Pizzocri S, et al. Transcatheter valve-invalve implantation using Corevalve Revalving System for failed surgical aortic bioprostheses. JACC Cardiovasc Interv, 2011, 4(11): 1228-1234.
19. Seiffert M, Conradi L, Baldus S, et al. Impact of patient-prosthesis mismatch after transcatheter aortic valve-in-valve implantation in degenerated bioprostheses. J Thorac Cardiovasc Surg, 2012, 143(3): 617-624.
20. Eggebrecht H, Schäfer U, Treede H, et al. Valve-in-valve transcatheter aortic valve implantation fordegenerated bioprosthetic heart valves. JACC Cardiovasc Interv, 2011, 4(11):1218-1227.
21. Choi CU, Rha SW, Chen KY, et al. Lack of clinical benefit of improved angiographic results with sirolimus-eluting stents compared with paclitaxel and zotarolimus-eluting stents in patients with acute myocardialinfarction undergoing percutaneous coronary intervention. Circ J, 2009, 73(12):2229-2235.
22. Williams DO, Abbott JD, Kip KE. DES cover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents:report of the DEScover Registry. Circulation, 2006, 114(20):2154-2162.
23. Casserly IP. Trans-radial treatment of in-stent restenosis of the superficial femoral artery--the importance of case selection. Catheter Cardiovasc Interv, 2009, 74(3):499.
24. Duwayri Y, Vallabhaneni R, Kirby JP, et al. Early protection and compression of residual limbs mayimprove and accelerate prosthetic fit:a preliminary study. Ann Vasc Surg, 2012, 26(2):242-249.
25. Amelot M, Foucault A, Scanu P, et al. Comparison of outcomes in patients with abandoned versus extracted implantable cardioverter defibrillator leads. Arch Cardiovasc Dis, 2011, 104(11):572-577.
26. Kato TS, Schulze PC, Yang J, et al. Pre-operative and post-operative risk factors associated with neurologic complications in patients with advanced heart failure supported by a left ventricular assist device. J Heart Lung Transplant, 2012, 31(1):1-8.
27. Sasaki T, Hansford R, Zviman MM, et al. Quantitative assessment of artifacts on cardiac magnetic resonance imaging of patients with pacemakers and implantable cardioverter-defibrillators. Circ Cardiovasc Imaging, 2011, 4(6):662-670.
28. D'Arpa S, Cordova A, Pignatti M, et al. Freestyle pedicled perforator flaps:safety, prevention of complications, and management based on 85 consecutive cases. Plast Reconstr Surg, 2011, 128(4):892-906.
29. Ostergard DR. Evidence-based medicine for polypropylene mesh use compared with native tissue vaginal prolapse repair. Urology, 2012, 79(1):12-14.
30. Sherrard LJ. Guidelines for a quality program. Occup Health Saf, 2008, 77(7):84, 86.
31. McKinney M. High-tech hazards. Alarm hazards tops ECRI list of health dangers. Mod Healthc, 2011, 41(45):18.
32. Marchessault L, Hoagland H. Making sense of electrical PPE. Occup Health Saf, 2011, 80(10):34, 36, 38.
33. 王兰明.医疗器械不良事件监测与风险管理浅议.中国药房, 2003, 14(9):516-519.
34. 高小燕, 李素敏, 崔泽实, 等.医学装备风险管理文献的计量研究.中国医学装备, 2013, 10(4):12-14.

Chinese Journal of Evidence-Based Medicine

International Research Focuses of Risk Management of Medical Devices: A Bibliometric Analysis

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