title: Issues of device safety in a developing country.
abstract: Safe use of medical devices is a comprehensive concept with its technical integration. It includes not only its procedural operations but also its vigilance to patient status, correct installation of device, proper user's education and training, appropriate device maintenance, user facility compatibility, and acceptable interference from environment. Consequently, in technology advanced countries, the safety of medical device can be monitored by the operations through both the premarket approval and the postmarket surveillance. This also implies that regulations and standards take its own significant role to the safe operations of medical device. However, with the integrated and hierarchical operation of regulations and standards on medical devices is even non-existent in most of developing and underdeveloping countries. This article presents safety issues of medical devices in these particular circumstances.
authors.affiliation: Clinical Engineer of Biomedical Engineering Society of the ROC, a specialist of Bureau of Pharmaceutical Affairs, and an active committee member of Bureau of Standards, Metrology and Inspection, Ministry of Economic Affairs. He worked at Biomedical Engineering Department as a Device Safety Coordinator for 11 years before his working at Department of Health. (Phone: 886-2-23210151 Ext.701; fax: 886-3-3711430; e-mail: jihsyl@ms22.hinet.net).
authors.forename: Jih-Horn
authors.initials: JH
authors.lastname: Stanley Chen
authors.forename: Alex
authors.initials: A
authors.lastname: Kou
authors.forename: Wei-Shiang
authors.initials: WS
authors.lastname: Lee