Medical Device Maintenance, Testing, and Quality Assurance
Maintenance, testing, and quality assurance tests whether devices perform to specification after service and over time. The exam emphasizes test methods, traceability, documentation, and quality indicators rather than a checklist mentality.
Core rules and concepts
- PM vs calibration: PM checks safety and function; calibration adjusts to a reference. A calibration sticker does not prove clinical performance.
- Traceability: test equipment should trace to national standards; record analyzer ID, calibration due date, and environmental conditions.
- In-service testing: IEC 62353 provides methods for equipment already in use, including protective earth, insulation, and leakage tests.
- Functional tests: verify alarms, outputs, and controls against manufacturer specifications; use simulated loads and patient simulators.
- Documentation: record as-found and as-left results, pass/fail, and corrective action in the CMMS.
- QA indicators: repeat failures, out-of-tolerance rates, and PM completion.
Worked example
An infusion pump set to 100 mL/h delivers 108 mL in one hour. Error = (108−100)/100 × 100 = 8%. With a ±5% specification, the pump fails and needs calibration or repair; document the as-found result first.
Traps
Do not pass a device because it powers on. Do not use an uncalibrated analyzer. Do not omit as-found data; it is needed for trend analysis.