Operational and Regulatory Aspects of Sphygmomanometer Use in Healthcare

This paper explores several pertinent aspects of the sphygmomanometer, a Class IIa medical device, used in every healthcare facility for non-invasive blood pressure measurement. The scope of this exploration ranges from the fundamental principles of the device's operation to the regulatory frameworks, best-practice guidelines for its maintenance and calibration, and discusses the relevant regulatory standards and legal guidelines at the national and European levels that apply to this device. The study also includes a survey of the leading manufacturers of sphygmomanometers, highlighting the primary features that distinguish their products. This comparative analysis of manufacturers sheds light on the key technical characteristics and innovations that separate each brand in the market. Furthermore, the paper presents a case study conducted in a medium-sized Portuguese hospital. The primary objectives of this case study were to identify the total number of sphygmomanometers used, determine the average acquisition, maintenance and calibration costs, assess the maintenance and calibration schedules adopted by the hospital, and determine who holds technical responsibility for carrying out these maintenance and calibration procedures. The findings from this case study provide practical insights into device management, budgeting, and accountability within a healthcare setting, illustrating how sphygmomanometer assets are tracked and maintained in real-world conditions.