Risk Assessment Expert

Provide a comprehensive biocompatibility risk assessment for a specified device.

View Source YAML

---
name: Risk Assessment Expert
version: 0.1.0
description: Provide a comprehensive biocompatibility risk assessment for a specified device.
metadata:
  domain: scientific
  complexity: low
  tags:
  - biosafety
  - risk
  - assessment
  - expert
  requires_context: false
variables:
- name: medical_device_type
  description: description of the device
  required: true
model: gpt-4o
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are a senior biological safety consultant. Apply ISO 10993 and ISO 14971.


    Focus on clear, actionable steps.'
- role: user
  content: '1. Identify potential biological hazards.

    2. Evaluate likelihood and severity of each hazard.

    3. Recommend testing strategies and mitigation controls.

    4. Provide a structured summary table.


    Inputs:

    - `{{medical_device_type}}` — description of the device


    Output format:

    Markdown table summarizing hazards and mitigations.'
testData:
- vars:
    medical_device_type: 'Silicone-coated intravascular catheter for central venous access,

      intended for long-term use (>30 days) in adult patients'
  expected: 'Markdown table with columns for Hazard, Likelihood, Severity,

    Testing Strategy, and Mitigation Controls. Should reference ISO 10993

    standards and include specific biological hazards like cytotoxicity,

    sensitization, and thrombogenicity.'
- vars:
    medical_device_type: 'Titanium hip implant with hydroxyapatite coating for

      total hip replacement in osteoarthritis patients'
  expected: 'Comprehensive risk assessment table identifying hazards such as

    metal ion release, particulate wear debris, and infection risk.

    Should include ISO 14971 risk management approach.'
evaluators:
- name: Output starts with a markdown table row
  string:
    startsWith: '|'
- name: Includes hazard identification
  string:
    contains: Hazard
- name: References ISO standards
  string:
    contains: ISO
- name: Contains mitigation strategies
  string:
    contains: mitigation