title: [Role of patient safety in the official approval of new surgical techniques and devices].
abstract: Health technological industry brings every year thousands of new devices to the market worldwide. However, there is a large gap between the process of device approval and the control after release. Although, drugs can be used in health care only if they underwent randomized placebo controlled trials there are only a few devices that had similar studies. Surgery is a dangerous part of medicine and new technologies can represent hazard for patient safety.
authors.affiliation: Magyar Betegbiztonsági Társaság Budapest Kerékgyártó u. 36-38. 1147. baranyai.zsolt@mabebit.hu
authors.forename: Zsolt
authors.initials: Z
authors.lastname: Baranyai
authors.forename: Valéria
authors.initials: V
authors.lastname: Jósa
authors.forename: László
authors.initials: L
authors.lastname: Kulin
mesh_terms: D018795:Device Approval / Q000592:standards; D006077:Government Agencies; D006801:Humans; D006814:Hungary; D061214:Patient Safety / Q000592:standards; D018579:Patient Selection / Q000941:ethics; D016032:Randomized Controlled Trials as Topic / Q000941:ethics; D006113:United Kingdom; D014481:United States; D014486:United States Food and Drug Administration