Poster: What happens in post-market reviews of medical devices in Australia

Australasian Society of Biomaterials and Tissue Engineering (ASBTE) Conference, 18 April 2017

18 May 2017
  • Poster by: Kelly Tsang, Medical Devices and Product Quality Division, Therapeutic Goods Administration
  • Presented at: Australasian Society of Biomaterials and Tissue Engineering (ASBTE) Conference
  • Presentation date: 18 April 2017
  • Poster summary: This presentation provides an update on post-market reviews of medical devices

Poster: What happens in Post-Market Reviews of Medical Devices in Australia

Post-market medical device review

The Australian Register of Therapeutic Goods (ARTG) has over 50,000 medical devices and over 5000 are added each year. Post-market procedures identify devices of interest to regulate ongoing device safety, quality and performance.

  1. Signal
    • Assess signal strength & priority
  2. Planning
    • Determine review scope & focus
  3. Evidence
    • Request & review evidence
  4. Action
    • Convey decision & recommendations
  5. Report
    • Release outcomes & findings

Adverse events signals

Thousands of adverse events are reported yearly from sponsors, consumers and medical staff. This information helps us identify potential issues, trends and signals.

Adverse event reports by source

Chart: Adverse event reports by source from 2010 to 2016: Doctors, Nurses, Sponsors, Consumers, Allied Health and Total.

Investigation outcomes

  • Guidance/ sponsor education to ensure products comply with
  • Essential Principles
  • Manufacturer quality and risk assessment procedures to minimise risk
  • Clinical evidence that supports product claims
  • Safety alert, recalls for product correction
  • Cancellation of devices from register that do not meet safety and efficacy requirements

Evidence evaluation

Sponsors and manufacturers need to demonstrate compliance with the Essential Principles as outlined in the Therapeutic Goods (Medical Devices) Regulations 2002. These principles ensure devices have procedures for quality control, risk management, safety considerations and clinical evidence justifying their effectiveness.

Evidence is reviewed by the post market team and often referred to TGA laboratories for testing and verification.

Post-market statistics

Financial Year Reviews completed Products cancelled
2014-15 162 39
2015-16 86 25
2016-17 188 40

Recent product reviews

  • Human Chorionic Gonadotrophin (hCG) urine pregnancy tests
  • Heater-coolers
  • First-aid kits
  • Automated external defibrillator (AED)
  • Infusion pumps
  • Breast implants- anaplastic large cell lymphoma (ALCL)
  • Baby pillows and positioners
  • Urogynaecological mesh