Module 16 2022

Creation of Hazard Identification document

Determine the potential harm to the user and/or patient and establish the severity associated

Identify the potential hazards of the device in both normal and fault conditions

Hazard Identification

with the harm by adequate subject matter experts ( clinical/medical expert)

ID

Hazard

Hazardous situation

P2

Harm to user

Severity

Comment (e.g. Possible cause examples) e.g. Loss of sterility during device preparation and administration

Harm /Severity & P2 Justification

Severity: Local Infection deemed equivalent to minor injury requiring medical attention P2 : Engineering and medical judgement - not all exposures to contamination will result in infection since people are exposed to such contamination on a daily basis and the immune system is sufficient to prevent infection in most cases.

HID_1

Microbial contaminant

Exposure to microbial contamination direct contact with skin/sensitive areas.

0.01 Local infection

3

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Business Use Only