Regulatory measures for implementing new medical devices. Recalling Boneloc.
Through the past decades, new medical devices have been introduced at an increasing pace at the urge primarily of manufacturers, clinicians, and patients. Whereas it is mandatory to assess and approve new pharmaceuticals before their widespread use is allowed, innovations in medical devices generally have not been subject to the same restrictions. The European Community's program on completion of the Internal Market has generated a series of three Directives regulating the safety, reliability, and marketing of practically all non-pharmaceutical medical products. Once CE-marked, devices are available throughout the Union, an area constituted of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union Directives were implemented, Boneloc was introduced to commercial distribution in the beginning of the nineties as a new and promising bone cement to be utilized in joint arthroplasty prostheses. While promptly gaining wide acceptance in most of the Nordic countries, Boneloc was after few years and about 5,500 implanted Scandinavian patients withdrawn from the market abruptly because of inferior fixation properties. Utilizing Boneloc as a test case, the present study critically examined whether a comparable incident could occur after the implementation of the European Union Directives and what strategies can be applied to avoid equivalent future misconduct.
Riehmann
Morten
M
Department of Urology, Lund University Hospital, S-221 85 Lund, Sweden.
D001843:Bone Cements / Q000009:adverse effects*; D003718:Denmark; D018795:Device Approval / Q000331:legislation & jurisprudence*; D005062:European Union; D006801:Humans; D008689:Methacrylates / Q000009:adverse effects*; D012537:Scandinavian and Nordic Countries
D001843:Bone Cements; D008689:Methacrylates; C073735:methylmethacrylate-n-decylmethacrylate-isobornylmethacrylate