FDA Letter of Authorization- Reissuance of Convalescent Plasma

Angie Szumlinski Health, Studies

On February 2, 2021, the U.S. Food and Drug Administration reissued an Emergency Use Authorization for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with Covid-19. This reissues the letter of authorization released on November 20, 2020, and also contained the following updates: Includes updates based on data from additional clinical trials. Clarifies that the …

FDA Import Alert on Alcohol-Based Hand Sanitizers

Angie Szumlinski Featured, Health

The US Food and Drug Administration has issued an import alert for alcohol-based hand sanitizers from Mexico. Largely due to the increase in the use of hand sanitizers in response to the Covid-19 pandemic, the FDA is issuing this warning to protect the safe supply of alcohol-based hand sanitizers and prevent products with dangerous ingredients from entering the country. In …

COVID-19 Vaccine Reactions – CDC MMWR

Angie Szumlinski Announcements, Health, News

The CDC has issued updated interim clinical considerations for use of mRNA COVID-19 vaccines currently authorized in the United States and interim considerations for preparing for the potential management of anaphylaxis. Anaphylaxis is a severe, life-threatening allergic reaction that occurs rarely after vaccination. In addition to screening for contraindications and precautions before administering COVID-19 vaccines, vaccine locations should have the …

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation

Angie Szumlinski Health

On January 8, 2021, the U.S. Food and Drug Administration (FDA) issued an alert warning that viral mutations of SARS-CoV-2 may produce false-negative results on current molecular tests. “The U.S. Food and Drug Administration is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the …

Risk of False Results with the Curative SARS-Cov-2 Test for COVID-19

Angie Szumlinski Health

The U.S. Food and Drug Administration (FDA) issued a statement describing the risks of false results with the Curative SARS-Cov-2 test, particularly false negative results. Risks to a patient who has received a false negative can include delayed care as well as lack of monitoring of infected individuals, which can result in increased community spread of the virus. Recommendations from …

FDA Statement on Following the Authorized Dosing Schedules for COVID-19 Vaccines

Angie Szumlinski Announcements, Health

On January 4th, 2021, the U.S. Food and Drug Administration (FDA) released a statement reiterating the importance of following the authorized dosing schedules for both approved COVID-19 vaccines. Efforts to increase the number of individuals immunized against COVID-19 by changing the doses or dosing schedules are said to run the risk of being counterproductive to public health. The FDA is …

JAMA- Coronavirus Vaccine FDA Update

Angie Szumlinski Health

The JAMA Network recently released a new video to their Q&A series that discussed the Pfizer/BioNTech and Moderna Covid-19 vaccines. Topics included: Pfizer EUA application Differences in EUAs for vaccines vs drugs Surprises in data Post-authorization safety surveillance Unknowns: duration of protection, asymptomatic transmission, virus mutation How vaccines can reduce non-COVID-19 excess deaths Patients with allergies Bell’s Palsy FDA role …

FDA Issues Warning to PPE Decontamination Manufacturer

Angie Szumlinski News

Battelle Memorial Institute received a warning letter from the Food and Drug Administration (FDA) in regards to its Critical Care Decontamination System. Battelle rose to the spotlight a few months ago when their Critical Care Decontamination System, which decontaminates N95 masks, received emergency approval for use by the FDA. Due to decontaminating PPE being fairly controversial in healthcare (PPE such …

Laws of Motion PPE – Surgical Gown Safety

Angie Szumlinski Health, News

The U.S. Food and Drug Administration (FDA) is alerting health care facility risk managers, procurement staff and health care providers that gowns sold as medical gowns including surgical gowns, sold by Laws of Motion PPE (LawsofMotionPPE.com) have potential quality issues that affect the level of fluid barrier protection. The FDA is recommending that gowns manufactured or sold by Laws of …

FDA – Sanitizer Warning List

Angie Szumlinski Announcements, Health, News, Studies

The FDA is warning people to avoid dozens of hand sanitizers because they may contain methanol, a substance that can be toxic when absorbed through the skin. Many of the products are labeled as containing ethanol, which is safe, but tested positive instead for methanol, also known as wood alcohol. The initial list of products made by Eskbiochem Sade CV …