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FDA Updates Information on Respirator Decontamination Systems

The U.S. Food and Drug Administration (FDA) is reissuing the Emergency Use Authorizations for decontamination systems that are authorized to decontaminate compatible N95 respirators for use by healthcare personnel (HCP) to prevent exposure to pathogenic biological...

First Patient Treated in Clinical Trial of BCL System

CairnSurgical, Inc., an innovator striving to make breast cancer surgery more precise, announced that the first patient has been treated in its U.S. pivotal trial of the Breast Cancer Locator (BCL) System at Massachusetts General Hospital.

Rush Oak Park Hospital Adopts Surgical Workflow Technology, ExplORer Surgical, Increasing Team Confidence and Reducing OR Challenges

ExplORer Surgical, the only comprehensive intraoperative case support and workflow platform, has reinvented the way surgical support teams prepare and complete effective surgeries with two-way video for case support and remote proctoring to create a digitized playbook.

AORN Releases 2021 Guidelines for Perioperative Practice

The Association of periOperative Registered Nurses (AORN) has published the 2021 Guidelines for Perioperative Practice with six revised guidelines.

FDA Issues COVID-19 Update

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • The FDA issued an Emergency Use Authorization (EUA) in response to concerns relating to insufficient supply and availability of gowns and other apparel, such as operating-room shoe covers, for use by health care personnel as personal protective equipment (PPE) for use in health care settings in accordance with Centers for Disease Control and Prevention recommendations to protect both health care personnel and patients from the transfer of SARS-CoV-2, the virus that causes COVID-19, in low or minimal risk level situations to prevent the spread of COVID-19.
  • The FDA provided flexibility to farms regarding eligibility for the qualified exemption under the Produce Safety Rule during the COVID-19 public health emergency. Farms that are currently eligible for the qualified exemption and associated modified requirements will still be considered eligible, even if they shift sales away from qualified end-users, so long as they continue to meet the requirement that their average food sales during the previous three years total less than $500,000 (adjusted for inflation).
  • The FDA approved an abbreviated new drug application (ANDA) for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated in addition to general anesthesia, to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Side effects of succinylcholine chloride injection include anaphylaxis, hyperkalemia, and malignant hyperthermia. The FDA recognizes the increased demand for certain products during the COVID-19 public health emergency, and we remain deeply committed to facilitating access to medical products to help address critical needs of the American public.
  • Testing updates:
    • During the COVID-19 pandemic, the FDA has worked with more than 400 test developers who have already submitted or said they will be submitting EUA requests to the FDA for tests that detect the virus or antibodies to the virus.
    • To date, the FDA has authorized 113 tests under EUAs, which include 100 molecular tests, 12 antibody tests, and 1 antigen test.

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