title: Medical device accident reporting: does it improve patient safety?
abstract: A significant number of patient injuries and deaths are associated with the use of medical devices. After several decades of experience in device evaluation and accident investigation, ECRI believes that many of these adverse effects could not be predicted in advance, even with the most sophisticated design validation techniques. Reporting networks with investigational capability that identify problem devices and provide feedback about adverse effects to manufacturers and medical device users are essential to meet the health communities obligation to provide safe and effective products and patient care.
authors.affiliation: ECRI, Plymouth Meeting, PA 19462-1298, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Nobel
mesh_terms: D000056:Accident Prevention; D016208:Databases, Factual; D004868:Equipment Failure; D004869:Equipment Safety; D004864:Equipment and Supplies; D005062:European Union; D011358:Product Surveillance, Postmarketing / Q000379:methods; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration