FDA Warns of Potential Pulse Oximeter Inaccuracies
Feb. 22, 2021 Pulse oximeters, which measure blood oxygen levels, have become popular during the COVID-19 pandemic for people to track their oxygen saturation, but they may not always be accurate, the FDA cautioned in new guidance released Friday.
Several factors can affect the accuracy of pulse oximeters, including poor circulation, skin temperature, skin thickness, current tobacco use, use of fingernail polish, and dark skin pigmentation, the FDA said. Recent reports have found that Black patients may not receive accurate readings from some oximeters.
“While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” William Maisel, MD, director of the FDA’s Office of Product Evaluation and Quality, said in a statement.
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Date issued: December 29, 2020
The U.S. Food and Drug Administration (FDA) is updating our February 2020 safety communication on laparoscopic power morcellators to provide new information on the safe and effective use of laparoscopic power morcellation for gynecologic procedures.
On December 29, 2020, the FDA issued the final guidance,
Product Labeling for Laparoscopic Power Morcellators. The final guidance provides recommendations concerning the content and format for certain labeling information to better inform patients and health care providers of the device s risks.
The FDA recommends performing laparoscopic power morcellation for myomectomy or hysterectomy only with a tissue containment system, legally marketed in the United States for use during laparoscopic power morcellation and performing these procedures only in appropriately selected patients. The recommendations for health care providers below have been updated from the February 2020 safety communication consistent