Non-invasive blood pressure cuff blood pressure measurement devices are clinically relied upon. For clinically recommended use, it must be able to provide reliable information as a basis for decision-making. For new things in the medical field, as long as they are better than the current ones, patients may like them because of the better experience. But for doctors, it must show advantages on the basis before it can be used clinically.
1. The medical community is very fond of non-invasive blood pressure cuff devices
For nearly a century, the medical community has relied on blood pressure cuffs to measure blood pressure. But there are some issues with the cuff. People with small or very large arms often have inaccurate measurements and patients don't like it. Cuff readings provide little information. For example, your blood pressure is different when you sit and relax than when you walk. Doctors want to know everyone's ambulatory blood pressure without the hassle of wearing a cuff. These can be monitored by ambulatory blood pressure, which is measured by a cuff every 20 minutes, but some people are annoyed by it and others won't use it. So doctors like the concept of a cuffless device and the idea of getting another layer of blood pressure information. But doctors are also concerned that approval of these devices is based on standards for cuff devices. These criteria work well and are helpful in evaluating cuffed devices, but are insufficient for cuffless devices.
2. For non-invasive blood pressure cuff measurements, they have different intended uses
For example, a wrist-worn cuffless sphygmomanometer, which can be worn for several weeks, requires a lot of measurements. Or a phone app where you have to press a button with your finger to take a measurement. This is a different measurement because the user decides when to read. Another type is facial video technology, which takes signals from the face and measures blood pressure. This is another measure for patients under anesthesia or in intensive care units.
Non-invasive blood pressure cuffs may require different validations in different application scenarios, not only in terms of technology but also in terms of intended use. We cannot develop a standard for cuffless blood pressure measurement without knowing the type of cuffless measurement. When we calibrate cuffed devices, we have a standard to refer to, but for cuffless devices, there is no information.
3. A completely different use for non-invasive blood pressure cuff monitoring is in ICU patients
In these cases, physicians do not want to measure blood pressure with an accuracy of ±5 mmHg. Instead, they want to detect a significant drop and know if they should rush to the patient urgently. And these Ph.Ds think there will be different standards. In the ICU, sudden changes are detected by continuous blood pressure monitoring with a NIBP cuff. It's a different technique. The verification method is different. In this case, the reference standard is the true intra-arterial measurement, different from mmHg.