You are here

  • Home
  • Archive
  • Volume 27, Issue 3
  • Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices

Responses

Article menu

Download PDFPDF

Original research
Factors influencing the reporting of adverse medical device events: qualitative interviews with physicians about higher risk implantable devices
Compose a Response to This Article
Compose Response

More information about text formats

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g. higgs-boson@gmail.com
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests

PLEASE NOTE:

  • A rapid response is a moderated but not peer reviewed online response to a published article in a BMJ journal; it will not receive a DOI and will not be indexed unless it is also republished as a Letter, Correspondence or as other content. Find out more about rapid responses.
  • We intend to post all responses which are approved by the Editor, within 14 days (BMJ Journals) or 24 hours (The BMJ), however timeframes cannot be guaranteed. Responses must comply with our requirements and should contribute substantially to the topic, but it is at our absolute discretion whether we publish a response, and we reserve the right to edit or remove responses before and after publication and also republish some or all in other BMJ publications, including third party local editions in other countries and languages
  • Our requirements are stated in our rapid response terms and conditions and must be read. These include ensuring that: i) you do not include any illustrative content including tables and graphs, ii) you do not include any information that includes specifics about any patients,iii) you do not include any original data, unless it has already been published in a peer reviewed journal and you have included a reference, iv) your response is lawful, not defamatory, original and accurate, v) you declare any competing interests, vi) you understand that your name and other personal details set out in our rapid response terms and conditions will be published with any responses we publish and vii) you understand that once a response is published, we may continue to publish your response and/or edit or remove it in the future.
  • By submitting this rapid response you are agreeing to our terms and conditions for rapid responses and understand that your personal data will be processed in accordance with those terms and our privacy notice.
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Vertical Tabs

Other responses

Jump to comment:

  • Published on: 21 May 2018
    Reporting of adverse medical device events: From both sides of the Atlantic.
    • alain braillon, senior consultant University Hospital, 80000 Amiens, France

    Gagliardi and her Canadian colleagues must be commended for calling a spade a spade: “there may be little point in solely educating or incentivising individual physicians to report adverse medical device events unless environmental conditions are conducive to doing so”.(1) “Environmental conditions” being “healthcare system capacity and industry responsiveness”.(1) The French state of affairs illustrates the latter is not about unresponsiveness but deliberate obstructions.

    First, in March 2017, after serial warning letters, the French regulatory agency required withdrawal of YSY Medical’s medical devices within a 6 months delay as devices have been marketed without CE marking (Conformité Européenne _European Conformity, in 1985 France was a leader in the Union_ which is about basic safety standards (eg. no explosion, no electrocution …). YSY Medical challenged the decision before a regional administrative court which: a) considered the topic was in its jurisdiction; b) issued an emergency ruling to suspend the Agency’s decision. The Conseil d’Etat, France’s highest court, confirmed the ruling in 2018.(2)

    Second, after a suit by the Snitem (National Union of Medical Technologies Industries) and Medtech (an association of 40 companies), the Conseil d’Etat just cancelled a decree (#1716. 13 Dec 2016) requiring a summary of product characteristics for class III and implantable devices.

    However, France is improving. In 2009, the Agency’s director wrote “...

    Show More
    Conflict of Interest:
    AB is an expert for several taskforces at the French regulatory agency (Agence Nationale de Sécurité des Médicaments et des produits de santé), none related to the topic