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Regulatory measures for implementing new medical devices. Recalling Boneloc (R)

Riehmann, Morten LU (2005) In Danish Medical Journal 52(1). p.11-17
Abstract
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 smae restrictions. The European Communitys 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 constitued of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union... (More)
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 smae restrictions. The European Communitys 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 constitued of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union Directives were implemented, Bonelec (R) 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acceptance in most of the Nordic countries, Bonelec (R) was after few years about 5,500 implanted Scandinavian patients withdrawn from the market abruptly because of inferior fixation properties. Utilizing Boneloc (R) 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. (Less)
Please use this url to cite or link to this publication:
author
organization
publishing date
type
Contribution to journal
publication status
published
subject
in
Danish Medical Journal
volume
52
issue
1
pages
11 - 17
publisher
Danish Medical Association
external identifiers
  • wos:000228038700002
  • pmid:16009069
ISSN
0907-8916
language
English
LU publication?
yes
id
6047a273-68d3-40c8-b487-0bd0d604e4d1 (old id 247144)
alternative location
http://www.dadlnet.dk/dmb/DMB_2005/0105/0105-artikler/DMB3341.htm
date added to LUP
2007-08-23 17:54:39
date last changed
2017-02-22 11:44:13
@article{6047a273-68d3-40c8-b487-0bd0d604e4d1,
  abstract     = {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 smae restrictions. The European Communitys 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 constitued of nearly half a billion citizens after the expansion to 25 Member States. Before the European Union Directives were implemented, Bonelec (R) 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, Bonelec (R) was after few years about 5,500 implanted Scandinavian patients withdrawn from the market abruptly because of inferior fixation properties. Utilizing Boneloc (R) 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.},
  author       = {Riehmann, Morten},
  issn         = {0907-8916},
  language     = {eng},
  number       = {1},
  pages        = {11--17},
  publisher    = {Danish Medical Association},
  series       = {Danish Medical Journal},
  title        = {Regulatory measures for implementing new medical devices. Recalling Boneloc (R)},
  volume       = {52},
  year         = {2005},
}