New endoluminal technology: efficacy and safety--whose responsibility?
New endoluminal technology is being increasingly used in the management of arterial disease. With this increased usage of often experimental devices there is a growing responsibility for clinicians to collect data and report adverse events particularly in the longer term, when initial feasibility studies have been concluded. Many of these devices will have a perceived advantage so great that randomized controlled trials are not feasible. It is important that these perceptions are based on robust data not clinical impressions. The following article discusses methods of device assessment and looks at who is responsible for ongoing device evaluation.
Buckenham
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Department of Radiology, Christchurch Public Hospital, PB 4710, Christchurch, New Zealand. Timb@cdhb.govt.nz
D017130:Angioplasty / Q000295:instrumentation* / Q000592:standards; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000601:surgery*; D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D009520:New Zealand; D011786:Quality Control; D011859:Radiography; D016032:Randomized Controlled Trials as Topic; D012015:Reference Standards; D015607:Stents / Q000009:adverse effects; D013679:Technology, Radiologic / Q000592:standards