Lax sphygmomanometer standard causes overdetection and underdetection of hypertension: a computer simulation study

Area of Science:

• Cardiovascular Medicine
• Biomedical Engineering
• Medical Device Standards

Background:

• Accurate blood pressure measurement is crucial for hypertension diagnosis and management.
• Current European standard EN 1060 permits systematic errors in noninvasive sphygmomanometers.
• These errors can lead to misdiagnosis of hypertension.

Purpose of the Study:

• To quantify the extent of hypertension overdetection and underdetection caused by sphygmomanometer errors.
• To evaluate the impact of systematic errors permitted by the EN 1060 standard on hypertension diagnosis.
• To assess the potential benefits of tighter error tolerances for sphygmomanometers.

Main Methods:

• Monte Carlo simulation was used to model blood pressure measurements in the Australian adult population.
• Simulations incorporated systematic sphygmomanometer errors compliant with EN 1060, random intraindividual BP variability, and random measurement error.
• Simulations were repeated with restricted systematic errors to +/-1 mmHg.

Main Results:

• Wide tolerances in the EN 1060 standard contribute to approximately 4.9% systolic and 11% diastolic hypertension underdetection.
• Permitted errors cause 5.8% systolic and 14% diastolic hypertension overdetection.
• Reducing permitted error to +/-1 mmHg improves hypertension detection comparable to an additional clinical visit.

Conclusions:

• Systematic sphygmomanometer errors allowed by the current EN 1060 standard are a significant, preventable cause of hypertension misdiagnosis.
• Revising the standard to minimize equipment-related errors is recommended.
• Negligible equipment errors would allow physiological variability to be the primary factor in diagnosis.