This presentation provided an overview of the lifecycle approach to regulation & the importance of reporting incidents to the TGA

1. 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

2. Lifecycle approach to regulation
Design & Development
TGA pre-market review
Production
Supply
TGA
post-market monitoring
Use, maintenance and disposal
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3. Premarket Supply Pathway
Step 1
2
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

4. 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

5. 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

6. 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
Reg
ister
Monitor
Changes to product information, safety alerts, recalls
Enforce compliance
Monitoring relies heavily on reports of INCIDENTS received from medical device users

7. 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 6

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Outline
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Why report incidents?
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Biomedical Engineers can make a special contribution
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Reports received from Biomedical Engineers
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Why Report to the TGA?
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Conclusion

9. Incident: Cracking Flow Meters
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Several (~20) flow meters in a hospital with cracked plastic “shrouds”.
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The supplier agreed to a once only replacement under warranty.
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Would you report this? To whom? Why? 8

10. 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 9

11. 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:

12. Importance of user reporting
•
Sponsors have mandatory reporting requirements but the TGA still relies on incident reports from users
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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.
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Evidence suggests that a substantial number of medical device incidents are NOT reported 11

13. TGA Investigation: Cracking Flow Meters
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The manufacturer concluded that the shrouds (made from PC plastic) were wiped with incompatible cleaning agents.
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TGA testing found that common cleaning agents have no effect on PC.
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Loctite® on PC + Stress leads to environmental stress cracking
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Loctite® was used by the Hospital Engineers during maintenance
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Case closed! (Don’t you think?)
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14. Biomedical Engineers are special…(yes, really)
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Medical devices are a diverse group of products ranging from bandages to complex implants:
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Tongue depressors - Surgical instruments
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Wheelchairs - Blood pressure monitors
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Syringes - Orthopaedic implants
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Catheter - MRI scanners
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Giving sets - Pacemakers
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Reporting requires the involvement of diverse clinical groups
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Biomedical Engineers purchase, install, maintain, service, and sometimes build many types of medical devices and should therefore be a major reporting group. 13

15. Source of Reports
graph image of the biomedical engineers report
Sponsor Reports:
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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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16. Barriers to Reporting
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Recognition
Liability
Confusion
Burden
Feedback

17. Outcome of Investigations
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Other Outcomes:
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Reviewed, trending purposes only
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2012: 1442
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2013: 1245
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Reviewed, No Further Action Required
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2012: 611
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2013: 1334
TGA publication was high in 2013 because of the 500+ reports received regarding the PIP issue.
graph image of the biomedical engineers report

18. 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. 17

19. Summary
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Reporting of medical device incidents – in house, to the manufacturer and to the TGA – is really important.
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Others can learn from your experience, and the report can help prevent reoccurrence.
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Biomedical Engineers are an important medical device user group
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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.
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The TGA can make a “meaningful contribution” to the investigation of incidents.
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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.
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We understand the barriers to reporting – it’s still worth persevering
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We are constantly trying to remove the barriers… 18

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PLEASE REPORT THE INCIDENT…
it could save a life!
http://www.tga.gov.au/safety/problem.htm iris@tga.gov.au 1800 809 361