title: The regulation of medical devices and quality of medical care.
abstract: Medical devices are now a pervasive part of modern medical care. They are in many cases associated with quality of care. In some cases, the use of devices has certainly improved quality. In other cases, devices can be associated with many problems. The approach to quality of devices has depended largely on regulation. However, regulation of devices in Europe is rather undeveloped, so in many cases the reliability and safety of a device has not been independently established and one cannot assume that a particular device in fact is reliable or safe. In addition, there are many problems in the interface between the machine and the user or the patient that are largely untouched by device regulation, and perhaps should be more often considered in quality assurance programs. As essential as device regulation is, it is not sufficient to assure quality. Education is particularly important in this area. Quality assurance programs need to be familiar with common problems with medical devices and how to approach them.
authors.affiliation: TNO/WHO Program on Health Care, Technology Assessment, Leiden, The Netherlands.
authors.forename: H D
authors.initials: HD
authors.lastname: Banta
authors.forename: W T
authors.initials: WT
authors.lastname: van Beekum
mesh_terms: D003274:Contraceptive Devices, Female / Q000592:standards; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005260:Female; D006801:Humans; D007391:International Cooperation; D011787:Quality of Health Care / Q000331:legislation & jurisprudence*; D012307:Risk Factors; D013673:Technology Assessment, Biomedical / Q000331:legislation & jurisprudence*; D014481:United States