The Experts below are selected from a list of 663 Experts worldwide ranked by ideXlab platform
Daniel B. Kramer - One of the best experts on this subject based on the ideXlab platform.
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transvenous implantable cardioverter defibrillator lead reliability implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
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Transvenous Implantable Cardioverter‐Defibrillator Lead Reliability: Implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
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Postmarket Surveillance of medical devices a comparison of strategies in the us eu japan and china
PLOS Medicine, 2013Co-Authors: Daniel B. Kramer, Chiaki Sato, Aaron S KesselheimAbstract:Medical devices play an increasingly vital role in health care delivery around the world. These technologies are defined in distinction to drugs as an “instrument, apparatus…machine…implant…or other similar or related article…which is…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease…and which does not achieve its primary intended purposes through chemical action” [1]. In recognition of the importance of medical devices, the World Health Organization established a Medical Device Unit to focus research and policy on prioritizing access to medical devices in low-resource settings, dessemination of innovations, and training of biomedical personnel to support the use of devices worldwide [2]. While medical devices offer opportunities for improved diagnosis and management of disease, they also can carry substantial risks. Governmental regulatory bodies considering new medical device approval balance the goals of expanding therapeutic options with safeguarding public health. Wherever the standard for market authorization is set, questions about a device's safety and effectiveness will remain after introduction into clinical practice. However, medical devices raise several unique challenges, including operator variability and procedural learning curves, permanent implantation, and the technological complexity of some devices. After a new medical device is brought to market, the process of Postmarket Surveillance (PS) provides an ongoing assessment of safety and effectiveness. High-profile international public health crises involving widely used implantable cardioverter-defibrillator leads [3],[4], joint prostheses [5], and breast implants [6] raise questions regarding the strengths and weaknesses of different approaches to device PS worldwide. Though only limited quantitative measures of PS guide policy decisions [7], we evaluated the range of device PS strategies in four important medical device markets—the US, EU, Japan, and China. The US and EU represent large markets that are entertaining substantial reforms to PS practice. Japan and China are, respectively, mature and emerging international markets that have systems that could inform ongoing policy debates in the US and EU and be influenced by their practices in turn. Our goal was to identify “best practices” from among these countries that could support the public health goals of all device regulatory systems.
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security and privacy qualities of medical devices an analysis of fda Postmarket Surveillance
PLOS ONE, 2012Co-Authors: Daniel B. Kramer, Benjamin Ransford, Quinn Stewart, Kevin Fu, Matthew Charles Baker, Andres Molinamarkham, Matthew R. ReynoldsAbstract:Background: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal Postmarket Surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.
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Security and privacy qualities of medical devices: An analysis of FDA Postmarket Surveillance
PLoS ONE, 2012Co-Authors: Daniel B. Kramer, Benjamin Ransford, Andres Molina-markham, Quinn Stewart, Kevin Fu, Matthew Baker, Matthew R. ReynoldsAbstract:BACKGROUND: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients' stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting.\n\nMETHODS: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices.\n\nRESULTS: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism.\n\nCONCLUSIONS: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal Postmarket Surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.
Robert G Hauser - One of the best experts on this subject based on the ideXlab platform.
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transvenous implantable cardioverter defibrillator lead reliability implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
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Transvenous Implantable Cardioverter‐Defibrillator Lead Reliability: Implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
Andrea J Cook - One of the best experts on this subject based on the ideXlab platform.
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Statistical approaches to group sequential monitoring of Postmarket safety Surveillance data: current state of the art for use in the Mini-Sentinel pilot.
Pharmacoepidemiology and drug safety, 2020Co-Authors: Andrea J Cook, Ram C Tiwari, Robert D Wellman, Susan R Heckbert, Lingling Li, Patrick J Heagerty, Tracey Marsh, Jennifer C NelsonAbstract:This manuscript describes the current statistical methodology available for active Postmarket Surveillance of pre-specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data. Motivation of the active Postmarket Surveillance setting is provided using the Food and Drug Administration's Mini-Sentinel Pilot as an example. Four sequential monitoring statistical methods are presented including the Lan-Demets error spending approach, a matched likelihood ratio test statistic approach with the binomial MaxSPRT as a special case, the conditional sequential sampling procedure with stratification, and a generalized estimating equation regression approach using permutation. Information on the assumptions, limitations, and advantages of each approach is provided, including how each method defines sequential monitoring boundaries, what test statistic is used, and how robust it is to settings of rare events or frequent testing. A hypothetical example of how the approaches could be applied to data comparing a medical product of interest, drug A, to a concurrent control drug, drug B, is presented including providing the type of information one would have available for monitoring such drugs. Copyright © 2012 John Wiley & Sons, Ltd.
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statistical approaches to group sequential monitoring of Postmarket safety Surveillance data current state of the art for use in the mini sentinel pilot
Pharmacoepidemiology and Drug Safety, 2012Co-Authors: Andrea J Cook, Ram C Tiwari, Robert D Wellman, Susan R Heckbert, Lingling Li, Patrick J Heagerty, Tracey Marsh, Jennifer C NelsonAbstract:Purpose This manuscript describes the current statistical methodology available for active Postmarket Surveillance of pre-specified safety outcomes using a prospective incident user concurrent control cohort design with existing electronic healthcare data. Methods Motivation of the active Postmarket Surveillance setting is provided using the Food and Drug Administration’s Mini-Sentinel Pilot as an example. Four sequential monitoring statistical methods are presented including the Lan–Demets error spending approach, a matched likelihood ratio test statistic approach with the binomial MaxSPRT as a special case, the conditional sequential sampling procedure with stratification, and a generalized estimating equation regression approach using permutation. Information on the assumptions, limitations, and advantages of each approach is provided, including how each method defines sequential monitoring boundaries, what test statistic is used, and how robust it is to settings of rare events or frequent testing. Results A hypothetical example of how the approaches could be applied to data comparing a medical product of interest, drug A, to a concurrent control drug, drug B, is presented including providing the type of information one would have available for monitoring such drugs. Summary We have described the current state of methodology for Postmarket Surveillance of pre-specified safety outcomes. We describe the limitations and advantages of the approaches while acknowledging areas for future development. Copyright © 2012 John Wiley & Sons, Ltd. key words—incident user cohort; observational study; Postmarket; group sequential monitoring; signal refinement; Surveillance
Laura A Hatfield - One of the best experts on this subject based on the ideXlab platform.
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transvenous implantable cardioverter defibrillator lead reliability implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
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Transvenous Implantable Cardioverter‐Defibrillator Lead Reliability: Implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
Deepa Mcgriff - One of the best experts on this subject based on the ideXlab platform.
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transvenous implantable cardioverter defibrillator lead reliability implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.
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Transvenous Implantable Cardioverter‐Defibrillator Lead Reliability: Implications for Postmarket Surveillance
Journal of the American Heart Association, 2015Co-Authors: Daniel B. Kramer, Laura A Hatfield, Deepa Mcgriff, Christopher R Ellis, Melanie T Gura, Michelle Samuel, Linda Kallinen Retel, Robert G HauserAbstract:Background As implantable cardioverter‐defibrillator technology evolves, clinicians and patients need reliable performance data on current transvenous implantable cardioverter‐defibrillator systems. In addition, real‐world reliability data could inform Postmarket Surveillance strategies directed by regulators and manufacturers. Methods and Results We evaluated Medtronic Sprint Quattro, Boston Scientific Endotak, and St Jude Medical Durata and Riata ST Optim leads implanted by participating center physicians between January 1, 2006 and September 1, 2012. Our analytic sample of 2653 patients (median age 65, male 73%) included 445 St Jude, 1819 Medtronic, and 389 Boston Scientific leads. After a median of 3.2 years, lead failure was 0.28% per year (95% CI, 0.19 to 0.43), with no statistically significant difference among manufacturers. Simulations based on these results suggest that detecting performance differences among generally safe leads would require nearly 10 000 patients or very long follow‐up. Conclusions Currently marketed implantable cardioverter‐defibrillator leads rarely fail, which may be reassuring to clinicians advising patients about risks and benefits of transvenous implantable cardioverter‐defibrillator systems. Regulators should consider the sample size implications when designing comparative effectiveness studies and evaluating new technology for preventing sudden cardiac death.