title: Critical assessment of new devices.
abstract: Medical devices are one of the most highly regulated products in the world. Despite this, there is an unacceptable rate of medical error. Not solely due to the device, but also the user and/or system in which it is used. The current approach to testing of medical devices must be progressed so the concept of user beware is changed to user be aware. All health professionals should be well informed as to the various aspects of each new device. Also, testing in research facilities that are equipped with qualified personnel and the proper testing methods should be supported. The outcome of good research then can be translated into good practice. This implementation requires constant communication for quality improvements from and to professional committees, educational leaders, and experts in the field. Medical devices are thoroughly tested before they are marketed, but we, as clinicians and users, must continuously examine and improve the design of equipment, procedures, personnel, and the environment in which we work to optimize medical systems. Once the device is on the market, changes or modifications are costly. Finally, a factor for success in critical testing of new devices is not what is technically possible, but rather making a concrete contribution to improving medical problems.
authors.affiliation: University Clinic of Tübingen, Germany. carole.hamilton@gmx.net
authors.forename: Carole
authors.initials: C
authors.lastname: Hamilton
mesh_terms: D004867:Equipment Design / Q000145:classification / Q000592:standards; D004868:Equipment Failure / Q000706:statistics & numerical data; D004869:Equipment Safety / Q000145:classification / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards; D032984:Ethics, Research; D005062:European Union; D005069:Evaluation Studies as Topic; D006801:Humans; D007255:Information Services / Q000592:standards; D019300:Medical Errors / Q000517:prevention & control*; D011358:Product Surveillance, Postmarketing / Q000379:methods* / Q000592:standards; D011786:Quality Control; D017751:Safety Management / Q000379:methods; D013673:Technology Assessment, Biomedical