Device Vigilance Local Challenges & Global Trends
Pam Carter Director, Device Vigilance and Monitoring Section Medical Devices Branch, TGA ARCS Conference 2018
21 August 2018
Topics Local challenges
• Medical Device reforms
– MMDR
– Inquiries and the results
• Relationship between sponsor and manufacturer
• Education and training
• Reporting of AEs
• Relationship with health facilities and professionals
Global hot topics and trends • Women’s health • Post market surveillance
– PSUR/Annual reporting – Life cycle responsibilities – Post market surveillance studies
• Reporting AEs – Electronic – Web forms – Databases – Harmonisation – Communication between regulators
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Local Challenges
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Expert Panel Review (MMDR) • Two reports released during 2015
– Medicines and Devices
– Complementary medicines and Advertising
• Review included discussion papers, submissions and interviews, followed by stakeholder workshops and other meetings
• Department considered feedback and advised Minister, who took preferred position to Cabinet
• Government intent released in May 2016 budget - full response released on 15 September 2016
– Government accepted 56 of the 58 Recommendations
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MMDR medical device projects • Key projects
• Designation of conformity assessment bodies in Australia
• Expedited review process for certain ‘novel’ devices
• Use of approvals from comparable overseas regulators
• Harmonisation with the European Union
• Strengthening of post market monitoring
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European Harmonisation MMDR recommendation:
• Align with new European regulatory framework where possible
• Clear rationale for Australian specific requirements
EU MDR and IVD Regulations came into force on 26 May 2017
Key changes include:
• Definitions
• Classification
• Conformity assessment procedures
• Essential Principles and General Safety & Performance Requirements
• EU regulations also capture in-house IVDs
• Implant cards and patient leaflets
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Medical Devices reforms Patient Implant Cards and Device Information Leaflets
• From 1 December 2018, patient implant cards will begin to be supplied with new implantable medical devices (starting with urogyanecological mesh)
• All permanently implantable devices are affected:
– Phased approach to be fully implemented by 1 December 2021
• Addresses an information gap
• Exempted products:
– simple implants (dental fillings, dental braces, tooth crowns, endosseous dental implants, screws, etc.)
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Medical Devices reforms Patient Implant Cards and Device Information Leaflets Must include the following information about the device:
Cards
– Name
– Model
– Batch code, lot number or serial number
– Unique device identifier (if any)
– Manufacturers name, address and website
Leaflets
– information identifying the device, or the kind of device
– the intended purpose
– information explaining how to use the device safely
– other information that the manufacturer considers would be useful for patients
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Post market monitoring • Better integration and timely analysis of
available datasets
• Electronic reporting of adverse events
• Enhanced information-sharing with overseas regulators
• Deferred: Implementation of registries for all high risk implantable device
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Reforms vs Recommendations from Inquiries • Reforms
– Quicker access to medical device technology through:
Multiple pathways to inclusion
Use of overseas approvals
• Inquiries
– Hips, breast implants, urogynaecological mesh, private health insurance, cosmetic industry, health technology
More oversight of medical devices pre and post market
More information for patients and health professionals
Medical Device Registries
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Relationships • Relationship between sponsor and manufacturer
– Signed agreements
– Flow of information
– Understanding the Australian regulatory system
• Relationship with health facilities and professionals
– inSite
– Who is reporting an adverse event and to whom
– Limitations of the Therapeutic Goods Act
– Expectations on sponsors and manufacturers
Replacement of devices
Reporting 10
Education and Training • Sponsors:
– Staying included
– Sponsor training day
– SME
– consultation
• Health Professionals
– inSite
– Web statements
– MDSU
– Consultation
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Reporting of AEs Still need to work on:
• No ARTG number
• Insufficient information
• Statistics
• Timely response to investigation
Getting better
• Submitting final reports
• Statistics
• Using web portal
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Global hot topics and trends
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Women’s health • Mesh • Breast implants • Contraceptive devices • Morcellators • Dermal fillers
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Post market surveillance • PSUR/Annual reporting
– Align with European guidance
• Life cycle responsibilities
– Post market surveillance studies
– MDSAP
– Post market reviews
Clinical Evidence Report
Risk assessment
Risk mitigations
Post-market vigilance
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Reporting Adverse Events • Electronic reporting • Web forms • Databases • Harmonisation
– Adverse event terminology codes Annex A: Problem terms and codes Annex B: Type of Investigation terms and codes Annex C: Investigation Findings terms and codes Annex D: Investigation Conclusion terms and codes To come: Annex E - Clinical Signs, Symptoms and Conditions,
and Annex F – Health Impacts • Communication between regulators
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