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Temperature threshold for burn injury: an oximeter safety study
David G Greenhalgh1, Mary Beth Lawless, Bradford B Chew
1Shriners Hospitals for Children Northern California, Sacramento, California 95817, USA.
The Journal of Burn Care & Rehabilitation
|September 9, 2004
Summary
Pulse oximeter probes are safe for patient monitoring up to 43°C for 8 hours. Temperatures above this threshold increase the risk of skin burn injury, necessitating careful device management.
Area of Science:
- Medical Devices
- Biomedical Engineering
- Dermatology
Background:
- Pulse oximeters are vital for patient oxygenation monitoring.
- Current FDA regulations limit probe temperature to 41°C.
- Prolonged probe use raises concerns about potential skin injury.
Purpose of the Study:
- To determine the precise temperature threshold for burn injury from pulse oximeter probes.
- To assess the safety of oximeter probes during extended monitoring periods.
- To evaluate the risk of thermal injury in well-perfused skin.
Main Methods:
- Eighteen patients undergoing skin excision surgery consented to probe application.
- Custom probes with LEDs were set at 42.5°C, 43°C, 43.5°C, and 44°C.
- Probes remained for up to 8 hours; skin was examined and histopathology performed.
Main Results:
- Erythema or superficial blisters were observed at 43°C (1 patient), 43.5°C (4 patients), and 44°C (9 patients).
- Histopathology revealed minimal to no injury in most cases.
- No burns were noted in two patients at unspecified temperatures.
Conclusions:
- Pulse oximeter probes are safe up to 43°C for at least 8 hours in well-perfused skin.
- Temperatures exceeding 43°C pose a risk of burn injury.
- Testing device safety on excised skin is a viable methodology.