title: The influence of the Product Liability Act, governmental regulation, and medical economics on medical devices and their clinical applications.
abstract: The advancement of medical technology constantly demands the introduction of safer and more efficient medical instruments and devices. Recent litigation and rulings against the manufacturers of breast implants and the subsequent refusal of major plastic companies to supply materials to them are seriously threatening the production and development of other permanent implants such as ventricular assist devices and even disposable catheters. In addition, government overregulation also discourages and hinders production and clinical applications of new instruments. Current trends such as cost effectiveness measures and economic restraints imposed by government agencies and managed care systems are endangering investments from the medical and industrial communities to exploit more expensive and sophisticated instrument technologies. The resultant lack of grant money and pressure from animal rights advocates also suppress experimentation on primates and domestic laboratory animals.
authors.affiliation: New York Medical College, New York City, USA.
authors.forename: T T
authors.initials: TT
authors.lastname: Hirose
mesh_terms: D000826:Animal Testing Alternatives / Q000331:legislation & jurisprudence; D000818:Animals; D003362:Cost-Benefit Analysis; D004869:Equipment Safety / Q000191:economics*; D004864:Equipment and Supplies / Q000191:economics* / Q000592:standards; D006077:Government Agencies; D017408:Guidelines as Topic; D006801:Humans; D016365:Liability, Legal; D016377:Organ Transplantation / Q000191:economics / Q000331:legislation & jurisprudence / Q000639:trends; D019736:Prostheses and Implants / Q000191:economics* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration