Module 16 2022

05/09/2022

Infusion Pump

Source

The process that gets this data

WHO + Process owners Methods to assess and collect the data Medical Affairs evaluate all FSCA’s reported Human Factors - during studies may identify incidents Medical Affairs – Clinical literature search for side effects

Indicators and threshold values for action - Review of risk management – New hazard from FSCA triggers a vigilance action If new harms, hazards or hazardous situations initiate risk evaluation

What to look for and where next

Serious incidents FSCA’s

We evaluate any FSCA’s issued since the last PSUR

New hazards New harms New failure modes

Existing PSUR

PSUR data

Non-serious incidents / side effects

PMCF – Survey

Internal Incident and side effects database

Compare our hazard analysis, harms data and confirm if new or a higher proportion of instances

ECRI database

Trending of occurrences not

within our estimated

PSUR data

Customer advocacy – Identify new complications

threshold values initiate vigilance

ALL CASES UPDATE Benefit / Risk ratio

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Source

The process that gets this data

WHO + Process owners Methods to assess and collect the data

Indicators and threshold values for action -

What to look for

Information from trending

Internal trending

External trending

Specialist literature, databases and / or registers Feedback data Users

Distributors

Importers

Public information similar devices

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