FDA warns about limitations and accuracy of pulse oximeters | 合法醫療器材資訊網

2021年2月19日—Apulseoximeter,adevicethatisusuallyplacedonafingertip,useslightbeamstoestimatetheamountofoxygencarriedintheblood(oxygen ...

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February 19, 2021

Media Inquiries   Shirley Simson   202-597-4230[2]

The following quote is attributed to William Maisel, M.D., MPH, director of the Office of Product Evaluation and Quality, in the FDA’s Center for Devices and Radiological Health:

“The FDA has issued a safety communication today to inform the public and health care providers of the limitations of these devices and to encourage individuals to pay close attention to all of their health symptoms, particularly if they are experiencing signs of low oxygen saturation levels, such as shortness of breath or bluish coloring of the face, lips, or nails. Patients should contact their health care provider with any concerns about increasing or worsening symptoms.

While pulse oximeters may be useful for estimating...