根据"通用标准",是否接受先前经过验证的血压自测设备? 一个系统的审查
Estefanie Siqueira Vigato de Oliveira1, Nila Larisse Silva de Albuquerque, Priscila Rangel Dordetto
1School of Nursing - University of Campinas (UNICAMP), Campinas, São Paulo, Brazil.
Journal of hypertension
|October 1, 2024
概括
大多数振荡计血压仪满足了最初的通用标准标准,但只有53%完全满足了自测验证的所有要求. 这影响了获得批准的家庭血压监测设备的可用性.
科学领域:
- 心血管诊断心血管诊断
- 医疗器械监管法规 医疗器械监管法规
- 高血压管理 高血压管理
背景情况:
- 精确的血压自测对于管理高血压至关重要.
- 对于振荡计设备的现有验证协议有所不同,可能会影响设备的批准.
- 该通用标准提供了验证血压监测设备的标准.
结论:
- 验证协议的显著差异导致分析的设备中只有53%符合通用标准的标准.
- 这项研究扩大了在通用标准下验证的自我测量设备的池.
- 需要在验证研究中进一步标准化,以确保可靠的家庭血压监测设备.
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