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Enhancing Compliance in Medical Device Regulations: Insights from the Global Codes Roundtable

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rufus
12 diapositives · 293 Views · Sep 14, 2014

The Medical Device Compliance Congress in Australia highlighted key issues in device regulation, focusing on the 3rd Edition of compliance standards. Discussions included advertisements and claims, healthcare professional interactions, and the need for ethical conduct among device makers. With a sharpened global compliance focus, inconsistencies with codes and the importance of training for company representatives were emphasized. A strengthened complaints committee aims to address breaches effectively. This congress serves as a vital platform for aligning industry practices with legal requirements.

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  1. Medical Device Compliance Congress: Global Device Codes Roundtable - Australia Anne Trimmer

  2. Agenda • Background to 3rd Edition • Advertising and claims • Dealings with healthcare professionals • Company representatives • Complaints • Code monitoring

  3. Background to 3rd Edition • Initial implementation 2 years ago • First complaint and appeal • Language issues • Increased compliance focus globally • Inconsistencies with AdvaMed Code and many member internal codes

  4. Headline news • Law on ties between surgeons, device makers insufficient • Kickback claims being taken 'very seriously' • Hip bones and hip pockets • Group calls for ethical conduct plan for Australian device makers

  5. Advertising – 3 tiers • Regulation • Therapeutic Goods Act and Regulations, Trade Practices Act • Co-Regulation • Therapeutic Goods Advertising Code • Self-regulation • Company codes • Voluntary industry codes • MTAA/MIANZ Code

  6. Dealings with healthcare practitioners • Definitions • Healthcare Practitioner • Other Professional • Member-sponsored training and education • Third party educational conferences • Member-sponsored symposia • Hospitality

  7. Dealings with healthcare practitioners • Hospitality and gifts • Consultancy arrangements • Donations and philanthropic gifts • Competitions for healthcare practitioners • Market research

  8. Company representatives • Requirement for ethical conduct • Not compromise professional independence of healthcare practitioner • Compliance with institutional standards, codes and laws • Requirement for every representative within 6 months and 3 year refresher • Training must be approved by MTAA

  9. Code complaints • Strengthened committee structure for complaints and appeals • Panel of 12 and independent chair: • Healthcare practitioners • Institutions • Consumer representatives • Industry

  10. Code complaints • Complaints from industry and non-industry • Industry must first raise with other member • Complaints committee may call on expert assistance • Breaches range from minor to serial • Maximum fine of $75,000 • Power to notify regulator

  11. Code monitoring • In addition to complaints process • Proactive monitoring – may call for material • Independent chair • May call for material or outline of activity