外周脉搏血氧仪标签为“非医疗用途”的临床解读。
Clinical Interpretation of Peripheral Pulse Oximeters Labeled "Not for Medical Use".
机构信息
Department of Anesthesiology, Uniformed Services University of the Health Sciences, Bethesda, Maryland
Department of Anesthesiology, Walter Reed National Military Medical Center, Bethesda, Maryland.
出版信息
Ann Fam Med. 2018 Nov;16(6):552-554. doi: 10.1370/afm.2317.
The purpose of our study was to clarify limitations of off-label use for low cost nonmedical use (NMU) pulse oximeters by primary care providers. These devices are widely marketed over the Internet and in drugstores but are not intended for medical use or reviewed by the Food and Drug Administration (FDA). Our study compared oxygen saturation (SpO) in patients from 1 medical use (MU) pulse oximeter to 8 NMU pulse oximeters. Measured arterial oxygenation (SaO) was compared with SpO when available. In patients who were normoxic (SpO ≥90%), all oximeters exhibited similar readings. This finding suggests that NMU pulse oximeters may be able to rule out hypoxemia in clinical settings.
我们的研究目的是阐明初级保健提供者将非医疗用途（NMU）低价脉搏血氧仪滥用于非医疗用途的局限性。这些设备在互联网和药店广泛销售，但并未被食品和药物管理局（FDA）用于医疗用途或审查。我们的研究将 1 个医疗用途（MU）脉搏血氧仪和 8 个 NMU 脉搏血氧仪的患者的血氧饱和度（SpO）进行了比较。当有条件时，将动脉氧饱和度（SaO）与 SpO 进行比较。在氧合正常的患者（SpO≥90%）中，所有血氧仪的读数均相似。这一发现表明，NMU 脉搏血氧仪可能能够在临床环境中排除低氧血症。
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