![]() ![]() The FDA will inform the public if significant new information becomes available. The FDA continues to monitor the current situation to help ensure that coagulation testing remains available for patients for whom such testing is medically necessary. ![]() On July 22, 2021, the FDA issued an Emergency Use Authorization (EUA) to Becton Dickinson for certain sodium citrate blood specimen (light blue top) collection tubes used to collect, transport and store blood samples for coagulation testing to aid in the identification and treatment of coagulopathy in patients with known or suspected COVID-19. On June 10, 2021, the FDA added these tubes (product codes GIM and JKA) to the section 506J of the Federal Food, Drug, and Cosmetic Act device shortage list during the COVID-19 public health emergency. The FDA also recommends health care and laboratory facilities develop and implement the above strategies to minimize the use of these tubes and maintain the quality and safety of care for patients for whom testing is medically necessary. Limit allocation of 1.8mL sodium citrate (light blue top) tubes for difficult blood collections.Do not use sodium citrate (light blue top) tubes as discard tubes consider clear top or red stopper (no additive) tubes as an alternative.Do not use sodium citrate (light blue top) tubes unless medically necessary.Do not include sodium citrate (light blue top) tubes in routine collections of a variety of specimens at the time of other blood sampling or IV insertion.The FDA recommends that health care providers, laboratory directors, phlebotomists, and other personnel consider the following conservation strategies: ![]() is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand during the COVID-19 public health emergency and recent vendor supply challenges. Food and Drug Administration (FDA) is aware that the U.S. For details, see the Blood Specimen Collection Tube Conservation Strategies - Letter to Health Care and Laboratory Personnel. JanuUpdate: The FDA expanded the medical device shortage list to include all blood specimen collection tubes. ![]()
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