title: Part I: Identifying holes in the safety net.
authors.affiliation: Duke Center for Education and Research on Therapeutics (CERTs) Research Center, Duke Clinical Research Institute, Durham, NC 27705, USA.
authors.forename: J Conor
authors.initials: JC
authors.lastname: O'Shea
authors.forename: Judith M
authors.initials: JM
authors.lastname: Kramer
authors.forename: Robert M
authors.initials: RM
authors.lastname: Califf
authors.forename: Eric D
authors.initials: ED
authors.lastname: Peterson
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004868:Equipment Failure; D004869:Equipment Safety / Q000379:methods* / Q000592:standards*; D019221:Mandatory Reporting; D009204:Myocardial Revascularization / Q000295:instrumentation; D018570:Risk Assessment; D015607:Stents; D013525:Surgical Instruments / Q000592:standards*; D013903:Thoracic Surgery / Q000295:instrumentation*; D014481:United States