Part I: Identifying holes in the safety net.
O'Shea
J Conor
JC
Duke Center for Education and Research on Therapeutics (CERTs) Research Center, Duke Clinical Research Institute, Durham, NC 27705, USA.
Kramer
Judith M
JM
Califf
Robert M
RM
Peterson
Eric D
ED
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