Verificaton Procedure for Blood Pressure Monitors245

1. Introduction

Blood pressure monitors are medical devices used to measure blood pressure. Accurate measurement of blood pressure is essential for diagnosing and managing cardiovascular diseases. Therefore, it is important to verify the accuracy of blood pressure monitors before using them in clinical practice.

2. Scope

This procedure outlines the steps for verifying the accuracy of blood pressure monitors. It applies to all types of blood pressure monitors, including manual, automated, and ambulatory blood pressure monitors.

3. Equipment
Standard mercury sphygmomanometer
Blood pressure monitor to be verified
Stethoscope
Thermometer
Barometer
Data recording sheet

4. Procedure
Obtain informed consent from the subject.
Ensure that the subject is in a comfortable sitting position with their arm supported at heart level.
Place the cuff of the blood pressure monitor on the subject's upper arm, ensuring that the lower edge of the cuff is 2-3 cm above the antecubital fossa.
Inflate the cuff to 20 mmHg above the expected systolic blood pressure.
Slowly release the air from the cuff while listening for Korotkoff sounds using the stethoscope.
Record the systolic blood pressure when the first Korotkoff sound is heard, and the diastolic blood pressure when the Korotkoff sounds disappear.
Repeat steps 4-6 using the standard mercury sphygmomanometer.
Compare the blood pressure measurements obtained using the blood pressure monitor to be verified with those obtained using the standard mercury sphygmomanometer.
Calculate the mean difference between the two sets of measurements.
If the mean difference is within ±5 mmHg, the blood pressure monitor is considered to be accurate.

5. Interpretation of Results

If the mean difference between the blood pressure measurements obtained using the blood pressure monitor to be verified and those obtained using the standard mercury sphygmomanometer is within ±5 mmHg, the blood pressure monitor is considered to be accurate.

If the mean difference is greater than ±5 mmHg, the blood pressure monitor is considered to be inaccurate and should not be used in clinical practice.

6. Reporting

The results of the verification procedure should be recorded on a data recording sheet. The report should include the following information:
Name and model of the blood pressure monitor
Date of verification
Name of the person performing the verification
Mean difference between the blood pressure measurements obtained using the blood pressure monitor to be verified and those obtained using the standard mercury sphygmomanometer
Conclusion regarding the accuracy of the blood pressure monitor

7. Quality Control

The accuracy of blood pressure monitors should be verified regularly to ensure that they are providing accurate measurements. It is recommended that blood pressure monitors be verified at least once a year, or more frequently if they are used frequently.

8. References
British Hypertension Society. (2011). Blood pressure measurement: A statement by the British Hypertension Society. Journal of Human Hypertension, 25(2), 79-89.
European Society of Hypertension. (2013). Guidelines for the management of arterial hypertension: The Task Force for the Management of Arterial Hypertension of the European Society of Hypertension. Journal of Hypertension, 31(4), 882-904.
International Organization for Standardization. (2018). ISO 81060-1:2018: Non-invasive sphygmomanometers – Part 1: General requirements.

2024-11-08

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