High risk devices
High risk devices are life supports, critical monitoring, energy emitting and other devices whose failure or misuse is reasonably likely to seriously injure patient or staff. Examples include:
- Anesthesia ventilators
- Anesthesia units
- Apnea monitors
- Argon enhanced coagulation units
- Aspirators
- Auto transfusion units
- Invasive Blood pressure units
- Fetal monitors
- Electrosurgical units
- Incubators
- Infusion pump
- Pulse oximeters
- External pacemaker
- Heart Lung Machine
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