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

iris@tga.gov.au 1800 809 361