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Volumn 32, Issue 3, 2011, Pages 309-317

An evaluation of a distributed medical device safety surveillance system: The DELTA network study

Author keywords

Interventional cardiology; Network study; Post market surveillance; Safety surveillance

Indexed keywords

ADVERSE OUTCOME; ARTICLE; COHORT ANALYSIS; COMPUTER NETWORK; CORONARY ARTERY DISEASE; CORONARY STENT; DATA ANALYSIS; DATA BASE; DEVICE; DRUG ELUTING STENT; EMBOLIC PROTECTION DEVICE; EMBOLISM; HUMAN; INTERVENTIONAL CARDIOVASCULAR PROCEDURE; LONGITUDINAL STUDY; MEDICAL AUDIT; MEDICAL SOCIETY; MORTALITY; OUTCOMES RESEARCH; PATIENT MONITORING; PATIENT SAFETY; PERCUTANEOUS CORONARY INTERVENTION; POSTMARKETING SURVEILLANCE; PREDICTIVE VALUE; REGISTER; STATISTICAL ANALYSIS; TREATMENT OUTCOME; UNITED STATES; VASCULAR CLOSURE DEVICE;

EID: 79953050583     PISSN: 15517144     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.cct.2011.02.001     Document Type: Article
Times cited : (21)

References (32)
  • 1
    • 68849085448 scopus 로고    scopus 로고
    • The new Sentinel Network-improving the evidence of medical-product safety
    • A 13
    • Platt R., Wilson M., Chan K.A., Benner J.S., Marchibroda J., McClellan M. The new Sentinel Network-improving the evidence of medical-product safety. N Engl J Med Aug 13 2009, 361(7):645-647.
    • (2009) N Engl J Med , vol.361 , Issue.7 , pp. 645-647
    • Platt, R.1    Wilson, M.2    Chan, K.A.3    Benner, J.S.4    Marchibroda, J.5    McClellan, M.6
  • 3
    • 33644852941 scopus 로고    scopus 로고
    • Postmarket surveillance for drug-eluting coronary stents: a comprehensive approach
    • F 14
    • Baim D.S., Mehran R., Kereiakes D.J., Gross T.P., Simons M., Malenka D., et al. Postmarket surveillance for drug-eluting coronary stents: a comprehensive approach. Circulation Feb 14 2006, 113(6):891-897.
    • (2006) Circulation , vol.113 , Issue.6 , pp. 891-897
    • Baim, D.S.1    Mehran, R.2    Kereiakes, D.J.3    Gross, T.P.4    Simons, M.5    Malenka, D.6
  • 4
    • 79953040235 scopus 로고    scopus 로고
    • Manufacturer, User Facility Device Experience Database - (MAUDE), Accessed February 3, 2010, at
    • Manufacturer, User Facility Device Experience Database - (MAUDE) Accessed February 3, 2010, at. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm.
  • 5
    • 79953063430 scopus 로고    scopus 로고
    • Massachusetts Data access center (MASS-DAC), Accessed February 3, 2010, at
    • Massachusetts Data access center (MASS-DAC) Percutaneous coronary intervention Cohort timeline summary Accessed February 3, 2010, at. http://www.massdac.org/pci.
    • Percutaneous coronary intervention Cohort timeline summary
  • 6
    • 33644663859 scopus 로고    scopus 로고
    • Monitoring device safety in interventional cardiology
    • M-A
    • Matheny M.E., Ohno-Machado L., Resnic F.S. Monitoring device safety in interventional cardiology. J Am Med Inform Assoc Mar-Apr 2006, 13(2):180-187.
    • (2006) J Am Med Inform Assoc , vol.13 , Issue.2 , pp. 180-187
    • Matheny, M.E.1    Ohno-Machado, L.2    Resnic, F.S.3
  • 7
    • 33947326964 scopus 로고    scopus 로고
    • A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices
    • A
    • Arora N., Matheny M.E., Sepke C., Resnic F.S. A propensity analysis of the risk of vascular complications after cardiac catheterization procedures with the use of vascular closure devices. Am Heart J Apr 2007, 153(4):606-611.
    • (2007) Am Heart J , vol.153 , Issue.4 , pp. 606-611
    • Arora, N.1    Matheny, M.E.2    Sepke, C.3    Resnic, F.S.4
  • 8
    • 64549159431 scopus 로고    scopus 로고
    • Validation of an automated safety surveillance system with prospective, randomized trial data
    • M-A
    • Matheny M.E., Morrow D.A., Ohno-Machado L., Cannon C.P., Sabatine M.S., Resnic F.S. Validation of an automated safety surveillance system with prospective, randomized trial data. Med Decis Making Mar-Apr 2009, 29(2):247-256.
    • (2009) Med Decis Making , vol.29 , Issue.2 , pp. 247-256
    • Matheny, M.E.1    Morrow, D.A.2    Ohno-Machado, L.3    Cannon, C.P.4    Sabatine, M.S.5    Resnic, F.S.6
  • 9
    • 56149126904 scopus 로고    scopus 로고
    • Rare adverse event monitoring of medical devices with the use of an automated surveillance tool
    • Matheny M.E., Arora N., Ohno-Machado L., Resnic F.S. Rare adverse event monitoring of medical devices with the use of an automated surveillance tool. AMIA Annu Symp Proc 2007, 518-522.
    • (2007) AMIA Annu Symp Proc , pp. 518-522
    • Matheny, M.E.1    Arora, N.2    Ohno-Machado, L.3    Resnic, F.S.4
  • 10
    • 0035919180 scopus 로고    scopus 로고
    • National health information privacy: regulations under the Health Insurance Portability and Accountability Act
    • J 20
    • Gostin L.O. National health information privacy: regulations under the Health Insurance Portability and Accountability Act. JAMA Jun 20 2001, 285(23):3015-3021.
    • (2001) JAMA , vol.285 , Issue.23 , pp. 3015-3021
    • Gostin, L.O.1
  • 11
    • 0035195534 scopus 로고    scopus 로고
    • American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee)
    • D
    • Cannon C.P., Battler A., Brindis R.G., Cox J.L., Ellis S.G., Every N.R., et al. American College of Cardiology key data elements and definitions for measuring the clinical management and outcomes of patients with acute coronary syndromes. A report of the American College of Cardiology Task Force on Clinical Data Standards (Acute Coronary Syndromes Writing Committee). J Am Coll Cardiol Dec 2001, 38(7):2114-2130.
    • (2001) J Am Coll Cardiol , vol.38 , Issue.7 , pp. 2114-2130
    • Cannon, C.P.1    Battler, A.2    Brindis, R.G.3    Cox, J.L.4    Ellis, S.G.5    Every, N.R.6
  • 12
    • 79953038716 scopus 로고    scopus 로고
    • American College of Cardiology's National Cardiovascular Data Registry's instrument, Accessed February 3, 2010, at
    • American College of Cardiology's National Cardiovascular Data Registry's instrument Accessed February 3, 2010, at. http://www.accncdr.com/WebNCDR/ELEMENTS.ASPX.
  • 14
    • 79953050894 scopus 로고    scopus 로고
    • Securing SQL Server, Accessed February 3, 2010, at
    • Securing SQL Server Accessed February 3, 2010, at. http://msdn.microsoft.com/en-us/library/bb283235(SQL.90).aspx.
  • 15
    • 77951622706 scopus 로고
    • The central role of the propensity score in observational studies for causal effects
    • Rosenbaum P., Ruben D. The central role of the propensity score in observational studies for causal effects. Biometrika 1983, 70:41-55.
    • (1983) Biometrika , vol.70 , pp. 41-55
    • Rosenbaum, P.1    Ruben, D.2
  • 17
    • 0041626110 scopus 로고    scopus 로고
    • Comparison of logistic regression versus propensity score when the number of events is low and there are multiple confounders
    • A 1
    • Cepeda M.S., Boston R., Farrar J.T., Strom B.L. Comparison of logistic regression versus propensity score when the number of events is low and there are multiple confounders. Am J Epidemiol Aug 1 2003, 158(3):280-287.
    • (2003) Am J Epidemiol , vol.158 , Issue.3 , pp. 280-287
    • Cepeda, M.S.1    Boston, R.2    Farrar, J.T.3    Strom, B.L.4
  • 18
    • 0032580377 scopus 로고    scopus 로고
    • Interval estimation for the difference between independent proportions: comparison of eleven methods
    • A 30
    • Newcombe R.G. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med Apr 30 1998, 17(8):873-890.
    • (1998) Stat Med , vol.17 , Issue.8 , pp. 873-890
    • Newcombe, R.G.1
  • 19
    • 60849116685 scopus 로고    scopus 로고
    • Some methods of propensity-score matching had superior performance to others: results of an empirical investigation and Monte Carlo simulations
    • F
    • Austin P.C. Some methods of propensity-score matching had superior performance to others: results of an empirical investigation and Monte Carlo simulations. Biom J Feb 2009, 51(1):171-184.
    • (2009) Biom J , vol.51 , Issue.1 , pp. 171-184
    • Austin, P.C.1
  • 20
    • 0032580320 scopus 로고    scopus 로고
    • Two-sided confidence intervals for the single proportion: comparison of seven methods
    • A 30
    • Newcombe R.G. Two-sided confidence intervals for the single proportion: comparison of seven methods. Stat Med Apr 30 1998, 17(8):857-872.
    • (1998) Stat Med , vol.17 , Issue.8 , pp. 857-872
    • Newcombe, R.G.1
  • 21
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • S
    • O'Brien P.C., Fleming T.R. A multiple testing procedure for clinical trials. Biometrics Sep 1979, 35(3):549-556.
    • (1979) Biometrics , vol.35 , Issue.3 , pp. 549-556
    • O'Brien, P.C.1    Fleming, T.R.2
  • 22
    • 3242684955 scopus 로고    scopus 로고
    • Exploration of a Bayesian updating methodology to monitor the safety of interventional cardiovascular procedures
    • J-A
    • Resnic F.S., Zou K.H., Do D.V., Apostolakis G., Ohno-Machado L. Exploration of a Bayesian updating methodology to monitor the safety of interventional cardiovascular procedures. Med Decis Making Jul-Aug 2004, 24(4):399-407.
    • (2004) Med Decis Making , vol.24 , Issue.4 , pp. 399-407
    • Resnic, F.S.1    Zou, K.H.2    Do, D.V.3    Apostolakis, G.4    Ohno-Machado, L.5
  • 23
    • 36849040670 scopus 로고    scopus 로고
    • Risk-adjusted sequential probability ratio test control chart methods for monitoring operator and institutional mortality rates in interventional cardiology
    • J
    • Matheny M.E., Ohno-Machado L., Resnic F.S. Risk-adjusted sequential probability ratio test control chart methods for monitoring operator and institutional mortality rates in interventional cardiology. Am Heart J Jan 2008, 155(1):114-120.
    • (2008) Am Heart J , vol.155 , Issue.1 , pp. 114-120
    • Matheny, M.E.1    Ohno-Machado, L.2    Resnic, F.S.3
  • 24
    • 0037294229 scopus 로고    scopus 로고
    • Risk-adjusted sequential probability ratio tests: applications to Bristol, Shipman and adult cardiac surgery
    • F
    • Spiegelhalter D., Grigg O., Kinsman R., Treasure T. Risk-adjusted sequential probability ratio tests: applications to Bristol, Shipman and adult cardiac surgery. Int J Qual Health Care Feb 2003, 15(1):7-13.
    • (2003) Int J Qual Health Care , vol.15 , Issue.1 , pp. 7-13
    • Spiegelhalter, D.1    Grigg, O.2    Kinsman, R.3    Treasure, T.4
  • 25
    • 0000563780 scopus 로고    scopus 로고
    • Monitoring surgical performance using risk-adjusted cumulative sum charts
    • D
    • Steiner S.H., Cook R.J., Farewell V.T., Treasure T. Monitoring surgical performance using risk-adjusted cumulative sum charts. Biostatistics Dec 2000, 1(4):441-452.
    • (2000) Biostatistics , vol.1 , Issue.4 , pp. 441-452
    • Steiner, S.H.1    Cook, R.J.2    Farewell, V.T.3    Treasure, T.4
  • 26
    • 79953041243 scopus 로고    scopus 로고
    • Mass-DAC data submission and report timelines, Report T., Accessed May 25, 2010 at
    • Mass-DAC data submission and report timelines, Report Timelines Accessed May 25, 2010 at. http://massdac.org/sites/default/files/PCITimelines.pdf.
  • 28
    • 9144265517 scopus 로고    scopus 로고
    • Surveillance of medical device-related hazards and adverse events in hospitalized patients
    • J 21
    • Samore M.H., Evans R.S., Lassen A., Gould P., Lloyd J., Gardner R.M., et al. Surveillance of medical device-related hazards and adverse events in hospitalized patients. JAMA Jan 21 2004, 291(3):325-334.
    • (2004) JAMA , vol.291 , Issue.3 , pp. 325-334
    • Samore, M.H.1    Evans, R.S.2    Lassen, A.3    Gould, P.4    Lloyd, J.5    Gardner, R.M.6
  • 29
    • 33847723010 scopus 로고    scopus 로고
    • Unanswered questions-drug-eluting stents and the risk of late thrombosis
    • M 8
    • Maisel W.H. Unanswered questions-drug-eluting stents and the risk of late thrombosis. N Engl J Med Mar 8 2007, 356(10):981-984.
    • (2007) N Engl J Med , vol.356 , Issue.10 , pp. 981-984
    • Maisel, W.H.1
  • 30
    • 33746931286 scopus 로고    scopus 로고
    • Recalls and safety alerts affecting automated external defibrillators
    • A 9
    • Shah J.S., Maisel W.H. Recalls and safety alerts affecting automated external defibrillators. JAMA Aug 9 2006, 296(6):655-660.
    • (2006) JAMA , vol.296 , Issue.6 , pp. 655-660
    • Shah, J.S.1    Maisel, W.H.2
  • 31
    • 78149345321 scopus 로고    scopus 로고
    • Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices
    • N 10
    • Resnic F.S., Gross T.P., Marinac-Dabic D., Loyo-Berrios N., Donnelly S., Normand S.L., et al. Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices. JAMA Nov 10 2010, 304(18):2019-2027.
    • (2010) JAMA , vol.304 , Issue.18 , pp. 2019-2027
    • Resnic, F.S.1    Gross, T.P.2    Marinac-Dabic, D.3    Loyo-Berrios, N.4    Donnelly, S.5    Normand, S.L.6
  • 32
    • 33749043388 scopus 로고    scopus 로고
    • Managing risks from medical product use: creating a risk management framework
    • U.S. Department of Health 26. 105 Code of Massachusetts Regulations. Department of Public Health, Rockville, MD, 130.1201-130.130
    • Managing risks from medical product use: creating a risk management framework. Report to the FDA Commissioner from the Task Force on Risk Management 2001, U.S. Department of Health 26. 105 Code of Massachusetts Regulations. Department of Public Health, Rockville, MD, 130.1201-130.130.
    • (2001) Report to the FDA Commissioner from the Task Force on Risk Management


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.