秘鲁数字血压计的验证状态:综合评估与验证过程算法建议
Fabian A Chavez-Ecos1,2, Sandra S Chavez-Malpartida3, Alexander M Parra-Huaroto1
1Facultad de Medicina Humana, Universidad Nacional San Luis Gonzaga, Ica.
Blood pressure monitoring
|September 3, 2025
概括
大多数在秘鲁网上销售的血压仪未经验证, 风险是高血压的读数不准确. 改善教育和监管对于秘鲁和拉丁美洲和加勒比地区的患者安全至关重要.
科学领域:
- 心血管健康
- 医疗器械法规
- 公共卫生
背景情况:
- 高血压是拉丁美洲和加勒比地区的主要死亡和残疾原因.
- 精确的高血压诊断和治疗取决于经过验证的血压测量器件 (BPMD).
- 在秘鲁,在线BPMD的可用性和验证状态基本上尚未评估.
研究的目的:
- 评估在秘鲁可在网上购买的血压测量设备的特性和验证状态.
- 确定在秘鲁在线市场中验证和未验证的BPMD的流行情况.
主要方法:
- 在2023年9月至11月期间对秘鲁主要在线零售商和药店进行了电子搜索.
- 根据2023年欧洲高血压学会 (ESH) 准则或制造商等效性,产品被归类为验证.
- 用一种拟议的算法来验证已识别的BPMD的验证状态.
主要成果:
- 在13家零售商和12家药房中共发现了530名BPMD.
- 在176个评估产品中,只有15个 (8. 5%) 得到了验证,而两个 (1. 1%) 被认为是相当的.
- 验证的设备使用ESH 2010,ISO 81060-2:2018或ESH 2002协议,Omron是最常见的品牌.
结论:
- 在秘鲁,高比例的未经验证的BPMD可在网上获得,造成不准确的血压读数的风险.
- 迫切需要对医生和患者进行关于BPMD验证的教育.
- 要求BPMD验证的监管政策对于加强秘鲁和拉美地区的高血压管理至关重要.
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