Investing in medical device safety: The importance of a functional Quality Management System

1. 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

2. 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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3. Bench to bedside to brand
Science
R&D
QMS
Good Brand
Good
Products
Good
Research
Death and
Injury
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4. 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
0
1000
2000
3000
4000
5000
6000
2011 2012 2013 2014 2015 2016 2017 2018
Year
Number of Reports
0 1000 2000 3000 4000 5000 6000
Death
Serious Injury
Temporary Injury
No Injury
Not Known
Breakdown of incidents 2014-2017
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5. 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

6. 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
Certification ≠ Compliance
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7. 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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8. Case study
• Patient monitoring device (ECG)- lack of audio
alarms when patient develops critical condition
• Caused by early failure of speaker component
• TGA noticed increased rate of failures over time
• Manufacturer investigated in 2012 and
improved design
• Improvement was not rolled out to older units
which were kept in service
0
20
40
60
80
100
120
2011 2012 2013 2014 2015 2016 2017
Year
Number of Reports Culmulative frequency
• TGA had questions on:
– amount of testing performed on speakers
– appropriateness of test conditions
– appropriateness of CAPA procedures
– appropriateness of health hazard evaluation
– extent of recall action taken
• TGA intervention led to
– recall of susceptible units
– review and ongoing improvements in company QMS
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9. 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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