title: The "art" of medicine and the "smokescreen" of the randomized trial off-label use of vascular devices.
abstract: Once a device is approved for sale in the United States by the Food and Drug Administration (FDA), it can legally be used by doctors to treat any condition a physician determines is medically appropriate. Based on postmarket published data and physician procedural experience, this may even become the standard of care when an alternative device either does not exist or is inferior in performance, even before FDA approval. This right of physicians to practice medicine without FDA approval is Federal law. The off-label use of medical devices for the treatment of peripheral vascular disease has recently become the latest target by groups with interests that have little to do with patient care. This interference has begun to negatively impact the latitude necessary for physicians to best treat their patients.
authors.affiliation: Center for Critical Limb Care, Riverside Methodist Hospital, University of Toledo Medical School, Columbus, Ohio 43214, USA. gansel@mocvc.com
authors.forename: Gary M
authors.initials: GM
authors.lastname: Ansel
authors.forename: Michael R
authors.initials: MR
authors.lastname: Jaff
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence; D004869:Equipment Safety; D033161:Government Regulation; D019983:Guideline Adherence; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply; D018579:Patient Selection; D016491:Peripheral Vascular Diseases / Q000601:surgery; D017410:Practice Guidelines as Topic; D010818:Practice Patterns, Physicians' / Q000331:legislation & jurisprudence; D011356:Product Labeling / Q000331:legislation & jurisprudence; D011787:Quality of Health Care; D016032:Randomized Controlled Trials as Topic; D012078:Renal Artery Obstruction / Q000601:surgery; D012107:Research Design; D018570:Risk Assessment; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence; D014656:Vascular Surgical Procedures / Q000009:adverse effects / Q000295:instrumentation* / Q000331:legislation & jurisprudence