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Research Studies is a compilation of published research articles funded by AHRQ or authored by AHRQ researchers.
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1 to 1 of 1 Research Studies DisplayedBates J, Parzynski CS, Dhruva SS
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: a case study of implantable cardioverter defibrillators.
The purpose of this study was to estimate medical device utilization needed to detect safety differences among implantable cardioverter defibrillators (ICDs) generator models and compare these estimates to utilization in practice. The investigators concluded that small safety differences among ICD generator models are unlikely to be detected through routine surveillance given current ICD utilization in practice, but large safety differences can be detected for most patients at anticipated average adverse event rates.
AHRQ-funded; HS022882.
Citation: Bates J, Parzynski CS, Dhruva SS .
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: a case study of implantable cardioverter defibrillators.
Pharmacoepidemiol Drug Saf 2018 Aug;27(8):848-56. doi: 10.1002/pds.4565..
Keywords: Cardiovascular Conditions, Heart Disease and Health, Medical Devices, Patient Safety, Registries, Surgery