Clinical Validation of medical devices usually authenticates the accuracy and overall functionality of the device. It assures the device’s reliability and accuracy to its future users.  For any medical device, clinical validation is an essential phase to evaluate the device’s overall performance as later on the device will be used by the mass population. In the blood pressure monitoring industry, there are also some renowned validation and certifications that every BP monitor needs to achieve, such as ESH, ISO, CE, Stride BP, BHS, and many more. Usually, blood pressure monitors that are gone through these validations are considered clinically accurate and approved for mass usage. And following the practice, the HINGMED clinical automatic blood pressure monitor; DBP-01P has been successfully validated by ISO 81060-2:2018.

What is ISO 81060-2:2018 validation?

In the past decades, blood pressure monitors are usually validated according to the British Hypertension Society protocol or the two editions of the European Society of Hypertension (ESH) protocols. Even though there are several attributes that are being considered in these validations, at that time arm size was not considered. This limitation is specifically prominent because recent blood pressure devices are equipped with single cuffs and use wide-range cuff sizes so that they can be used more efficiently. To surpass this limitation, along with other attributes International Organization for Standardization (ISO) protocol 81060-2:2018 has included the attribute of the wide-range cuff for single-cuff blood pressure monitors.

Automatic blood pressure device description

For the purpose of the research, HINGMED provided two DBP-01P devices from the normal production line. Working on the oscillometric principle HINGMED DBP-01P is a fully automatic desktop BP monitor. It has been developed and manufactured by Shenzhen Hingmed Medical Instrument Co., Ltd (Shenzhen, China). This upper arm digital device’s measuring range is from 40 to 260 mmHg for systolic and from 20 to 210 mmHg for diastolic pressure. with a large display and built-in printer, It also allows about 9999 data storage of BP and heart rate data. The data can be transferred to a PC/ HIS/Kiosk for analysis via USB, RS232, or Ethernet (optional function) for further analysis. The feature of the wide-range cuff used in this study is applicable for 17cm to 42cm arm circumferences and every efficient for patients with any arm size. The innovative modular design ensures the easy maintenance of the device. Two air pumps work alternately to ensure 100,000 measurements.

Certification procedure

In the supervision of Claudio Fania, Antonella Giletto, Valentina Zanello from Villa Maria Hospital, and Paolo Palatini from the University of Padova, 85 subjects had been tested from the general population using a wide-range arm circumferences cuff from 17 to 42 cm and approved by the institutional review board of the Villa Maria Hospital and performed according to the Declaration of Helsinki. In the study, 3 devices including an upper arm mercury sphygmomanometer were used and four consecutive measurements had been performed according to the ISO 81060-2:2018 protocol. The analysis was performed with the help of Systat version 12 and MedCalc version 19 software and published in the “Blood Pressure Monitoring” journal.

Conclusion

After the analysis has been done, it has been seen that the mean difference was 1.32 ± 3.18 mmHg for systolic & 0.78 ± 3.15 mmHg for diastolic. The data of 85 subjects were satisfied with the ISO 81060-2:2018 protocol respectively for the general population with a wide range of arm sizes using a single cuff.

In the past, regulatory organizations had not considered the arm circumference among the requirements for the validation process as there were different sizes of cuffs for adults. But with technological advancement, single-cuff BP monitors are being used in modern times. That is why for clinical blood pressure monitors such as DBP-01P, it is very necessary to add the attribute of the cuff in the process of validation. Thankfully, ISO 81060-2:2018 universal protocol has included the arm size in the BP device validation study and that will definitely bring the reliability of usage in the BP monitoring device industry in that process of study HINGMED clinical automatic BP monitor; DBP-01P will always be 1st recommendation from the researchers of the University of Padova and Villa Maria Hospital. (You can visit: https://journals.lww.com/bpmonitoring/pages/default.aspx)