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 includes
- 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
Medium risk devices
These are devices including many diagnostic instruments whose misuse, failure or absence (e.g. out of service with no replacement available would have a significant impact on patient care, but would not be likely to cause direct serious injury. Examples are
- ECG
- EEG
- Treadmills
- Ultrasound sensors
- Phototherapy units
- Endoscopes
- Surgical drill and saws
- Laparoscopic insufflators
- Phonocardiographs
- radiant warmers (Adult)
Low risk devices
Devices in this category are those whose failure or misuse is unlikely to result in serious consequences. Some examples for such equipments include
- Electronic thermometer,
- Breast pumps
- Surgical microscope
- Ultrasonic nebulizers
- Sphygmomanometers
- Surgical table
- Surgical lights.
- Temperature monitor
- Aspirators
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