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’

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Bench to bedside to brand

Science R&D QMS

Good Brand Good Products Good Research

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Death and Injury

Medical device incident report (DIR) analytics

• Over 5000 DIRs reported each year

– Incidents can lead to death or serious injury, or potential for injury – Known complications account for 41% of issues – Most others are rooted in QMS upon investigation Cause of incident

Known Complication Manufacturing process Mechanical problem Electrical Other Software Quality system deficiency Labelling Biological

1000 2000 3000 4000 5000 6000 2011 2012 2013 2014 2015 2016 2017 2018 Year

Number of Reports

1000 2000 3000 4000 5000 6000

Death Serious Injury Temporary Injury No Injury Not Known

Breakdown of incidents 2014-2017

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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

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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

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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?

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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 120

– review and ongoing improvements in company QMS

100 20 40 60 80 2011 2012 2013 2014 2015 2016 2017 Year

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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

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