101 devices

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Clinical guidelines call for the user of an upper arm blood pressure (BP) measurement device that has been validated for clinical accuracy for self-measured blood pressure (SMBP). However, a validated wrist cuff blood pressure (BP) device may be used in place of an upper arm device for certain clinical indications, specific patient needs, or additional circumstances (eg, upper arm cuff not suitable for patient arm circumference, unavailability of devices with the appropriate small, large or extra large size cuffs, medical conditions where upper arm devices cannot or should not be used).Proper technique is especially important when using a wrist cuff device to obtain accurate readings. The device must be correctly placed over the radial artery and held at heart level when readings are taken, with limited movement or wrist flexion.

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Clinical guidelines call for the user of an upper arm blood pressure (BP) measurement device that has been validated for clinical accuracy for self-measured blood pressure (SMBP). However, a validated wrist cuff blood pressure (BP) device may be used in place of an upper arm device for certain clinical indications, specific patient needs, or additional circumstances (eg, upper arm cuff not suitable for patient arm circumference, unavailability of devices with the appropriate small, large or extra large size cuffs, medical conditions where upper arm devices cannot or should not be used).Proper technique is especially important when using a wrist cuff device to obtain accurate readings. The device must be correctly placed over the radial artery and held at heart level when readings are taken, with limited movement or wrist flexion.

Independent Review Process

The final decision on whether a BP device meets the VDL Criteria is made solely by the Independent Review Committee, with no influence from the AMA.

Independent Review Process