2023
Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators
Dhruva S, Ridgeway J, Ross J, Drozda J, Wilson N. Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators. BMJ Surgery Interventions & Health Technologies 2023, 5: e000167. PMID: 36704544, PMCID: PMC9872505, DOI: 10.1136/bmjsit-2022-000167.Peer-Reviewed Original ResearchHealth systemReal-world evidence generationDevice identificationPrior conceptual modelInformation technologyHealth system characteristicsWorkflow changesNetworkReal-world evidenceImplementationResearch NetworkClinical benefitSupply chainMedical devicesSystem characteristicsTechnologyRWE studiesEffectiveness studiesCurrent stateConceptual modelBrief surveyMixed-method studySustainment (EPIS) frameworkInterview topicsMedical device safetyAdding device identifiers to claims forms—a key step to advance medical device safety
Kadakia K, Dhruva S, Ross J, Krumholz H. Adding device identifiers to claims forms—a key step to advance medical device safety. The BMJ 2023, 380: p82. PMID: 36631149, DOI: 10.1136/bmj.p82.Commentaries, Editorials and Letters
2022
Sensible regulation and clinical implementation of clinical decision support software as a medical device
Mori M, Jarrin R, Lu Y, Kadakia K, Huang C, Ross JS, Krumholz HM. Sensible regulation and clinical implementation of clinical decision support software as a medical device. The BMJ 2022, 376: o525. PMID: 35228206, DOI: 10.1136/bmj.o525.Commentaries, Editorials and Letters
2020
Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011
Rathi VK, Krumholz HM, Masoudi FA, Ross JS. Postmarket Clinical Evidence for High-Risk Therapeutic Medical Devices Receiving Food and Drug Administration Premarket Approval in 2010 and 2011. JAMA Network Open 2020, 3: e2014496. PMID: 32857145, PMCID: PMC7455850, DOI: 10.1001/jamanetworkopen.2020.14496.Peer-Reviewed Original Research