Hazard – A possible source of danger or a condition, which could result in human injury.
Hazard Analysis – Identification of hazards and their initiating causes.
Hazard Mitigation – Reduction in the severity of the hazard, the likelihood of the occurrence, or both.
Major Level of Concern – The Level of Concern is major if operation of the software associated with device function directly affects the patient, operator, and/or bystander so that failures or latent flaws could result in death or serious injury to the patient, operator, and/or bystander, or if it indirectly affects the patient, operator, and/or bystander (e.g., through the action of care provider) such that incorrect or delayed information could result in death or serious injury to the patient, operator, and/or bystander.
Moderate Level of Concern – The Level of Concern is moderate if the operation of the software associated with device function directly affects the patient, operator, and/or bystander so that failures or latent design flaws could result in non-serious injury to the patient, operator, and/or bystander, or if it indirectly affects the patient, operator, and/or bystander (e.g., through the action of the care provider) where incorrect or delayed information could result in non-serious injury of the patient, operator, and/or bystander.
Minor Level of Concern – The Level of Concern is minor if failures or latent design flaws would not be expected to result in any injury to the patient, operator, and/or bystander.
Serious Injury – as adopted from the Medical Device Reporting (MDR) regulation in the Code of Federal Regulations 21 CFR 803.3 (aa), means an injury or illness that either:
1. is life threatening, or
2. results in permanent impairment of a body function or permanent damage to a body structure, or
3. necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.