Examples Of Possible Hazards And Contributing Factors Associated With Medical Devices

Energy hazards

- Electricity;

- Heat;

- Mechanical force;

- Ionizing radiation;

- Non‑ionizing radiation;

- Electromagnetic fields;

- Moving parts;

- Suspended masses;

- Patient support device failure;

- Pressure (vessel rupture);

- Acoustic pressure;

- Vibration;

- Magnetic fields, e.g. MRI

Biological hazards

- Bio‑burden;

- Bio‑contamination;

- Bio‑incompatibility;

- Incorrect output (substance / energy);

- Incorrect formulation (chemical composition);

- Toxicity,

- (Cross‑) infection;

- Pyrogenicity,

- Inability to maintain hygienic safety‑,

- Degradation.

Environmental hazards

- Electromagnetic interference;

- Inadequate supply of power or coolant;

- Restriction of cooling;

- Likelihood of operation outside prescribed environmental conditions;

- Incompatibility with other devices;

- Accidental mechanical damage;

- Contamination due to waste products and/or device disposal.

Hazards related to the use of the device

- Inadequate labeling;

- Inadequate operating instructions;

- Inadequate specification of accessories;

- Inadequate specification of pre‑use checks;

- Over‑complicated operating instructions;

- Unavailable or separated operating instructions;

- Use by unskilled/untrained personnel;

- Reasonably foreseeable misuse;

- Insufficient warning of side effects;

- Inadequate warning of hazards likely with re‑use of single use devices;

- Incorrect measurement and other metrological aspects;

- Incorrect diagnosis;

- Erroneous data transfer,

- Mispresentation of results;

- Incompatibility with consumables / accessories / other devices,

Hazards arising from functional failure, maintenance and ageing

- Inadequacy of performance characteristics for the intended use;

- Lack of, or inadequate specification for maintenance, including inadequate specification of post maintenance functional checks;

- Inadequate maintenance; ‑ lack of adequate determination of end of device life;

- Loss of mechanical integrity;

- Inadequate packaging (contamination and/or deterioration of the device);

- Improper re‑use.