The U.S. FDA said the class I recall of the Trevo XP Provue retriever device by Stryker Neurovascular, of Fremont, Calif., is due to the risk that the device’s core wire may break or separate during device retraction. The separation could lead to injury or death, and the FDA said 11 injuries and one fatality have been reported. Stryker issued a notice to customers instructing them to segregate any unused inventory for return. The recall affects nearly 1,260 devices distributed in the U.S. between Sept. 18, 2019, and July 7, 2020.
CDC updates vaccine guidance
In a Nov. 9 update to its COVID-19 vaccine guidance, the U.S. CDC said its Advisory Committee on Immunization Practices (ACIP) will quickly hold a public meeting to review all the data when the FDA authorizes or licenses a SARS-CoV-2 vaccine. Based on the data, ACIP will vote on whether to recommend the vaccine and advise on who should receive the vaccine. The ACIP recommendations must be approved by the CDC director before becoming official policy, according to the agency. As a result of the work ACIP already has done, it is considering four groups to possibly recommend as the first to get the vaccine when supplies will be limited – health care workers, workers in essential and critical industries, people at high risk for severe COVID-19 illness due to underlying medical conditions and those who are 65 or older. In making its final recommendations for a specific vaccine, ACIP will be driven by the goals of decreasing death and serious disease as much as possible, preserving the functioning of society, reducing the extra burden the coronavirus is having on people already facing disparities, and increasing the chance for everyone to enjoy health and well-being, according to the guidance.
Russia launches doctor-driven shortage reporting service
The Russian Ministry of Health launched a new online service to better track shortages of drugs, devices and personal protective equipment needed in treating COVID-19 cases. Part of the State Services portal, the new site will allow doctors to submit proposals for organizing COVID-19 care, as well as comments on the lack or shortage of medical products and equipment, procedures for vaccinating medical personnel and problems with providing routine care. The information collected will be sent to the head of the regional health management body for prompt resolution, according to the ministry.