Validation up-date.

Area of Science:

• Cardiovascular technology
• Medical device evaluation
• Hypertension research

Background:

• Automated and semi-automated blood pressure devices are increasingly marketed.
• Existing validation protocols (AAMI, BHS) are difficult to fulfill.
• A need exists for standardized, practical evaluation criteria.

Purpose of the Study:

• To introduce the European Society of Hypertension (ESH) International Protocol for blood pressure device validation.
• To simplify and rationalize existing validation procedures.
• To ensure reliable evaluation of automated and semi-automated blood pressure monitors.

Main Methods:

• Based on data from 19 validation studies using AAMI and BHS protocols.
• Critical assessment and rationalization of previous validation methodologies.
• Elimination of pre-validation phases and simplification of observer recruitment/training.

Main Results:

• Simplified validation procedures without compromising rigor.
• Reduced number of subjects and relaxed blood pressure range requirements.
• Early elimination of non-viable devices, improving efficiency.

Conclusions:

• The ESH International Protocol offers a more practical approach to blood pressure device validation.
• The new protocol maintains the merits of earlier, more complex methods.
• Facilitates reliable assessment for purchasers of blood pressure monitoring devices.