presentation: life cycle of medical devices
DESCRIPTION
This presentation provided an overview of the lifecycle approach to regulation & the importance of reporting incidents to the TGATRANSCRIPT
Life Cycle of Medical Devices Lifecycle approach to regulation & The Importance of Reporting Incidents to the TGA
Olivia Reeves Devices Conformity Assessment Section, Office of Device Authorisation Dr Jorge Garcia Principal Scientific Adviser, Office of Product Review, TGA Australian Biomedical Engineering Conference 20 August 2014
Lifecycle approach to regulation
Design & Development
TGA pre-market review
Production Supply
TGA post-market monitoring
Use, maintenance and disposal
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Premarket Supply Pathway Step 1
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Step 2 Step 3 Submit Evidence of CA Procedure
TGA Certificate
CE Certificate
Declaration of Conformity
Submit Application for Entry in ARTG
Inclusion on ARTG
Application Audit
Conformity Assessment
TGA
European Notified
Body Higher risk devices
Lifecycle approach to regulation
Essential principles
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Design & Development
Production Supply
Use, maintenance and disposal
TGA pre-market review
TGA post-market monitoring
Life Cycle of Medical Devices The Importance of Reporting Incidents to the Therapeutic Goods Administration
Dr Jorge Garcia Principal Scientific Adviser, Office of Product Review, TGA Australian Biomedical Engineering Conference 20 August 2014
Monitoring, Surveillance and Vigilance
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Learning from experience gained the early and mid-life of medical devices
The TGA’s role is to continually monitor and evaluate the safety and performance of medical devices and to manage any risks associated with individual products.
The TGA is involved
throughout the lifecycle in a number of
ways
Assess evidence Register
Monitor
Changes to product information, safety alerts, recalls
Enforce compliance
Monitoring relies heavily on reports of INCIDENTS received from medical device users
What are (Medical Device) Incidents? • Events involving* medical devices that have resulted in, or
could have resulted in (i.e. near misses), harm to a patient, health professional or other person
• Other issues involving* medical devices that have not led to harm, but affect quality, timeliness and cost-effectiveness of health care delivery and may, if it happens often enough, lead to harm
* “Involving” in this case means associated with the use, or misuse, of a medical device – either caused or partially attributable to a device
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Outline • Why report incidents? • Biomedical Engineers can make a special contribution • Reports received from Biomedical Engineers • Why Report to the TGA? • Conclusion
Incident: Cracking Flow Meters • Several (~20) flow meters
in a hospital with cracked plastic “shrouds”.
• The supplier agreed to a once only replacement under warranty.
• Would you report this? To whom? Why?
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Why Report Incidents? “Adverse event (incident) reporting is the communication of an event or an issue to those who can make a contribution towards a meaningful outcome”
After ECRI: Medical Device Adverse Event Reporting under the SMDA - 1998
“To err is human, but not to learn from mistakes and not to communicate the lessons learnt from those mistakes is inexcusable”
Dr Jorge Garcia, Principal Scientific Adviser, Office of Product Review, TGA
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What happens to incident reports?
• Collects, and where necessary investigates, incident reports from sponsors, other regulatory agencies and medical device users, including hospital staff
• Can consult expert advisory committees if necessary • Disseminates information and/or oversees corrective actions
(e.g. safety alerts, product or labelling changes) • Exchanges information with other regulatory agencies
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The TGA:
Importance of user reporting • Sponsors have mandatory reporting requirements but the
TGA still relies on incident reports from users • User reports help the TGA identify patterns that help it
monitor safety and performance of medical devices and gauge the effectiveness of Manufacturer market surveillance systems.
• Evidence suggests that a substantial number of medical device incidents are NOT reported
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TGA Investigation: Cracking Flow Meters • The manufacturer concluded that the
shrouds (made from PC plastic) were wiped with incompatible cleaning agents.
• TGA testing found that common cleaning agents have no effect on PC.
• Loctite® on PC + Stress leads to environmental stress cracking
• Loctite® was used by the Hospital Engineers during maintenance
• Case closed! (Don’t you think?) 12
Biomedical Engineers are special…(yes, really) • Medical devices are a diverse group of products ranging from
bandages to complex implants: ‒ Tongue depressors - Surgical instruments ‒ Wheelchairs - Blood pressure monitors ‒ Syringes - Orthopaedic implants ‒ Catheter - MRI scanners ‒ Giving sets - Pacemakers
• Reporting requires the involvement of diverse clinical groups • Biomedical Engineers purchase, install, maintain, service, and
sometimes build many types of medical devices and should therefore be a major reporting group.
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Source of Reports
0
50
100
150
200
2012 Total: 22632013 Total; 3309
Sponsor Reports: – 2012: 1824 – 2013: 2456
Biomedical Engineers report about 25
incidents per year Patient, Surgeon reports up in 2013 due to the PIP silicone breast implant issue
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Barriers to Reporting
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Recognition
Liability
Confusion
Burden
Feedback
Outcome of Investigations
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Other Outcomes: • Reviewed, trending purposes only
– 2012: 1442 – 2013: 1245
• Reviewed, No Further Action Required – 2012: 611 – 2013: 1334
TGA publication was high in 2013 because of the 500+ reports received regarding the PIP issue.
0
20
40
60
80
100
1202012 Total: 2263
2013 Total: 3309
Outcomes: Cracking Flow Meters Safety Alert and change to the device instructions: Loctite® should not be used to seal the flow meter inlet thread during servicing. Design change: The hole in the PC plastic shroud is no longer an “interference fit” with the gas inlet fitting.
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Summary • Reporting of medical device incidents – in house, to the manufacturer and to the
TGA – is really important. – Others can learn from your experience, and the report can help prevent reoccurrence.
• Biomedical Engineers are an important medical device user group – There is evidence that there is substantial under reporting of incidents – by everyone - not just
Biomedical engineers . But it is critical for Biomedical Engineers to be involved in reporting.
• The TGA can make a “meaningful contribution” to the investigation of incidents. – The TGA has qualified, experienced staff and well equipped laboratories. Our statistics, the
DAEN online database, and our web publications demonstrate a good track record.
• We understand the barriers to reporting – it’s still worth persevering – We are constantly trying to remove the barriers…
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PLEASE REPORT THE INCIDENT… it could save a life!
http://www.tga.gov.au/safety/problem.htm
[email protected] 1800 809 361