Investing in medical device safety: The importance of a functional - PowerPoint PPT Presentation

Investing in medical device safety: The importance of a functional Quality Management System Dr Kelly Tsang Devices Vigilance and Monitoring Section Medical Devices Branch Therapeutic Goods Administration 3 April 2018 ASBTE conference

Therapeutic Goods Administration (TGA) • Part of the Australian Government Department of Health • Australian regulator for medicines, medical devices and products of biological origin • Regulatory decisions based on the Therapeutic Goods Act 1989 • Balancing industry and public healthcare needs • ‘Better health and wellbeing for all Australians through regulatory excellence’ 1

Bench to bedside to brand Good Brand Good Products Good QMS Research R&D Science Death and Injury 2

Medical device incident report (DIR) analytics Number of Reports • Over 5000 DIRs reported each year 6000 – Incidents can lead to death or serious injury, or 5000 potential for injury 4000 3000 – Known complications account for 41% of issues 2000 – Most others are rooted in QMS upon investigation 1000 Cause of incident 0 2011 2012 2013 2014 2015 2016 2017 2018 Known Complication Year Manufacturing process Breakdown of incidents 2014-2017 Mechanical problem Not Known Electrical No Injury Other Software Temporary Injury Quality system deficiency Serious Injury Labelling Death Biological 3 0 1000 2000 3000 4000 5000 6000

Quality management system (QMS) • Long term investment- research, validation, post market monitoring • Benefits and risks may stay with the patient forever • QMS- protect your investment by ensuring quality- controlling processes and products • Ensuring all products conform and meet quality requirements • Investing in quality by controlling product and processes – Note Australian clinical context may be different from other countries – Think about the country in which the product is marketed and use the correct models 4

Having a QMS is only the beginning • ISO 13485 Medical devices —QMS — Requirements for regulatory purposes • Post-market is the real test of QMS – a living system • Common QMS deficiencies: – QMS not updated, not revisited after first production  Decline in product/ batch quality  Trends not recognised in time – QMS not triggered adequately when incident occurs  Incidents not reported to TGA  Insufficient investigation  Limited corrective and preventive action • TGA involvement to ensure device safety 5

When things go wrong • Lets manufacturer investigate and implement changes • TGA gets involved when we think there’s insufficient clarity or action • Review documentation, stats, results of investigation  Failure Mode and Effect Analysis (FMEA)  Risk assessment documents (SRA, HHE)  Corrective And Preventive Action (CAPA) • Is the QMS functioning?  Have the right QMS processes been triggered?  Have the correct root causes been determined and is it reasonable?  Are corrective and preventive measures appropriate?  Was appropriate recall action taken to eliminate the issue?  Did the device comply with all relevant Essential Principles? 6

Case study • Patient monitoring device (ECG)- lack of audio • TGA had questions on: alarms when patient develops critical condition – amount of testing performed on speakers • Caused by early failure of speaker component – appropriateness of test conditions • TGA noticed increased rate of failures over time – appropriateness of CAPA procedures • Manufacturer investigated in 2012 and – appropriateness of health hazard evaluation improved design – extent of recall action taken • Improvement was not rolled out to older units • TGA intervention led to which were kept in service – recall of susceptible units Number of Reports Culmulative frequency – review and ongoing improvements in company QMS 120 100 80 60 40 20 0 2011 2012 2013 2014 2015 2016 2017 7 Year

Take home message • Medical device manufacturing is a significant, long term development that can have a big impact on people’s lives • Invest in quality and listen to engineers • Look after the QMS and keep it active Next TGA session- Tania Ahmed Wed 16:55 Rottnest room Regulation of High-risk Medical Devices in Australia from a Biomaterials Perspective 8