Product Safety
This domain tests how healthcare organizations and suppliers keep medical products safe from design through disposal: device selection, sterile processing, traceability, adverse event reporting, and recalls.
Core rules
- Apply risk management across the product lifecycle, including design controls, verification and validation, labeling, and postmarket surveillance.
- Maintain traceability: unique device identification (UDI), lot numbers, expiration dates, and where each item was used or stored.
- Follow manufacturer instructions for use (IFU) for cleaning, disinfection, sterilization, and single-use designation. Reprocessing a single-use device without validated procedures is a safety risk.
- Report adverse events and suspected device malfunctions to the manufacturer and regulator within required timeframes; preserve the device and packaging when possible.
- Manage recalls by identifying affected stock, quarantining it, tracing patients if needed, and documenting effectiveness checks.
- Store products under controlled temperature, humidity, and security; rotate stock by expiry.
Worked example
Several infusion pumps overheat. Do not simply remove one pump. Quarantine the affected model/lots, identify patients and inventory, report the adverse event, contact the manufacturer, and check recall notices. The reasoning: a product problem may be lot-specific or design-related; traceability allows targeted action and prevents repeat exposure.
Traps
- Treating regulatory clearance (FDA, CE, etc.) as proof that a device is safe in every use.
- Losing lot/UDI traceability, making recalls slow and incomplete.
- Delaying adverse event reports while investigating internally.
- Ignoring IFU constraints during reprocessing.