Electrocardiogram failure in the operating room - bench testing to prevent bed-side disaster.

Area of Science:

• Biomedical Engineering
• Anesthesiology
• Medical Device Technology

Background:

• Peri-operative environments present challenges for accurate electrocardiogram (ECG) monitoring due to electrical interference.
• Advanced integrated monitoring systems aim to reduce artifacts but can introduce new issues.
• False alarms and monitoring failures pose risks for critical incidents and patient harm.

Observation:

• A series of apparent ECG flatline asystolic events occurred post-implementation of new intra-operative monitoring systems.
• Root cause analysis revealed complete loss of ECG signal correlated with increasing electrical resistance.
• Clinical and laboratory testing identified heightened sensitivity to impedance changes in the new ECG systems.

Findings:

• The new ECG systems, despite design improvements for signal fidelity, exhibited increased susceptibility to impedance variations.
• Software and hardware modifications by the manufacturer were necessary to address the signal loss issue.
• The root cause was identified as the interplay between system sensitivity and peri-operative impedance fluctuations.

Implications:

• Addressing device sensitivity to impedance is crucial for reliable intra-operative ECG monitoring.
• Effective communication between clinicians and manufacturers is vital for rapid problem resolution.
• System updates can mitigate risks associated with advanced medical monitoring technology, ensuring patient safety.