Clinical validation protocols for noninvasive blood pressure monitors and their recognition by regulatory authorities and professional organizations: rationale and considerations for a single unified protocol or standard.

Standardized protocols for validating the clinical accuracy of noninvasive blood pressure (NIBP) monitors have been available since 1987. Some of them were developed by standards bodies and others by professional organizations. They have been well-tested through use and progressively improved through multiple revisions; however, many methodological differences exist between them. In addition, for the purpose of regulatory approval or marketing clearance, some protocols are recognized in some countries but not in others; thus, manufacturers have to validate their NIBP monitors to more than one protocol in order to market them worldwide. The use of different protocols not only makes it difficult to compare one device with another but also complicates the validation, regulatory approval, marketing, and public acceptance of NIBP monitors, creating undue burden on manufacturers and unnecessary confusion among users. There is a need for protocol developers, standards bodies, and regulatory authorities to work together to develop and agree on a single unified protocol or standard, one that builds on the strengths of the various protocols that have been developed so far. It is apparent that there is already a trend toward convergence of the various protocols into two protocols, namely, the ISO 81060-2:2009 standard and the 2010 European Society of Hypertension International Protocol. With further reconciliation and consensus, it should be possible to integrate the best features of the ISO, European Society of Hypertension, and other protocols, along with further improvements, into a single unified protocol or standard.