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Evaluation of blood pressure measuring devices
Clinical and Experimental Hypertension (New York, N.Y. : 1993)
|November 1, 1993
Summary
Blood pressure device validation is crucial for accuracy. New protocols improve device comparison and manufacturer engagement, though limitations in special populations and high pressures remain.
Area of Science:
- Biomedical Engineering
- Clinical Measurement
- Medical Device Regulation
Background:
- Blood pressure measuring device validation is an emerging research area.
- Two primary national protocols exist: American Association for the Advancement of Medical Instrumentation (AAMI) and British Hypertension Society (BHS), both recently revised.
- 19 devices have undergone validation using these protocols.
Purpose of the Study:
- To evaluate the current state of blood pressure measuring device validation.
- To identify the benefits and limitations of existing validation protocols.
- To highlight areas for improvement in device accuracy assessment.
Main Methods:
- Validation of 19 blood pressure measuring devices.
- Application of AAMI and BHS validation protocols.
- Analysis of protocol strengths and weaknesses.
Main Results:
- Protocols have increased awareness of potential inaccuracies and facilitated device comparison.
- Protocols have improved interaction between manufacturers and the medical profession.
- Identified weaknesses include the 'gold standard' fallibility, lack of special population/circumstance validation, and pressure-dependent accuracy issues.
Conclusions:
- Existing validation protocols have positively impacted the field.
- Further refinement is needed to address protocol limitations, particularly for special populations and varying pressure levels.
- The revised BHS protocol shows an attempt to mitigate some identified deficiencies.