Returned Product Analysis (RPA) involves physically and functionally evaluating medical devices that have been returned from patients to investigate complaints, collect evidence, and create investigation reports. This process is done to comply with regulatory post-market surveillance requirements. The RPA lab analyzes a variety of electronics and implantable medical devices using methods like functional testing, burn-in testing, troubleshooting, incubation, cleaning, rebuilding, and soldering to identify any issues.

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Returned Product Analysis
Kyle DelloRusso

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Kyle DelloRusso
• RPA Tech Intern
• Objectives:
– Professional Knowledge and Experience
– Outside perspective

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Returned Product Analysis (RPA)
• Regulatory – Post Market Surveillance
• Complaint Investigations:
– Physically Evaluated
– Functionally Tested
– Evidence Collected
– Investigation Report
• Reportable Complaints

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Electronics Lab
• HMII Pocket Controllers
• HMIII Controllers
• Patient Cables
• EPC Controllers
• Power Modules
• Display Modules
• Batteries/ Clips

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Pocket Controller (PC)

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Preliminary Evaluation

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Functional Testing

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Burn-In

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Troubleshooting

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Bio Lab
• Percutaneous Leads
• HMII Pumps

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Initial Evaluation

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Incubator/Soup

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Oven

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Clean

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Sonicator

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Clean and Rebuild

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Rebuild

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Soldering

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Functional Testing

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Sanitizer

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Reflections

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Thank You, Any Questions?