2023
Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
Mooghali M, Ross J, Kadakia K, Dhruva S. Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study. Medical Devices Evidence And Research 2023, 16: 111-122. PMID: 37229515, PMCID: PMC10204764, DOI: 10.2147/mder.s412802.Peer-Reviewed Original ResearchCross-sectional studyClass I medical deviceClass IHigh-risk medical devicesSerious adverse eventsSafety concernsAdverse eventsMedian numberUS FoodRecalled deviceTherapeutic useDevice recallsHigh-risk devicesDevice useSerious safety concernsMedical device recallsMultiple recallsLife-sustaining devicesDevice assessment
2021
Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock
Dhruva SS, Ross JS, Mortazavi BJ, Hurley NC, Krumholz HM, Curtis JP, Berkowitz AP, Masoudi FA, Messenger JC, Parzynski CS, Ngufor CG, Girotra S, Amin AP, Shah ND, Desai NR. Use of Mechanical Circulatory Support Devices Among Patients With Acute Myocardial Infarction Complicated by Cardiogenic Shock. JAMA Network Open 2021, 4: e2037748. PMID: 33616664, PMCID: PMC7900859, DOI: 10.1001/jamanetworkopen.2020.37748.Peer-Reviewed Original ResearchMeSH KeywordsAgedAssisted CirculationCross-Sectional StudiesExtracorporeal Membrane OxygenationFemaleHeart ArrestHeart-Assist DevicesHospitals, High-VolumeHospitals, Low-VolumeHospitals, TeachingHumansIntra-Aortic Balloon PumpingMaleMiddle AgedMyocardial InfarctionPercutaneous Coronary InterventionRisk FactorsShock, CardiogenicConceptsMicroaxial left ventricular assist deviceIntra-aortic balloon pumpLeft ventricular assist devicePercutaneous coronary interventionAcute myocardial infarctionMechanical circulatory support devicesCardiogenic shockHospital-level variationSignificant hospital-level variationCirculatory support devicesMCS devicesUse of IABPDevice useMedian proportionAcute Myocardial Infarction ComplicatedCardiology-National Cardiovascular Data RegistryChest Pain-MI RegistryLimited clinical trial evidenceNational Cardiovascular Data RegistryMyocardial Infarction ComplicatedFirst medical contactSupport devicesClinical trial evidenceExtracorporeal membrane oxygenationCoronary artery stenosis