Pulse Oximeter Accuracy and Limitations | 合法醫療器材資訊網

2021年2月19日—PrescriptionoximetersarereviewedbytheFDA,receive510(k)clearance,andareavailableonlywithaprescription.TheFDArequiresthat ...

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UPDATE: November 7, 2022

On November 1, 2022, the FDA convened a virtual public meeting of the CDRH Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee[2] to share information and perspectives from interested parties about ongoing concerns that pulse oximeters may be less accurate in individuals with darker skin pigmentations.

The FDA is reviewing the committee’s recommendations and will consider additional actions as needed. The FDA will share with the public any additional updates to the information and recommendations below.

Date Issued: February 19, 2021

The Coronavirus Disease 2019 (COVID-19) pandemic has caused an increase in the use of pulse oximeters, and a recent report (Sjoding et al.[3]) suggests that the devices may be less accurate i...