Royal Phillips NV, of Amsterdam, said in an April 8 statement that it has agreed to terms with the U.S. government for a quadrupling of the company’s production of hospital ventilators. The first doubling of output is scheduled to be on track by May 2020 while the second doubling of output will be achieved by the third quarter of 2020. The monthly volume of ventilator output will reach 4,000 units in the third quarter while the overall volume for 2020 will be 43,000 units.
Reps. Bennie Thompson (D-Miss.) and Carolyn Maloney (D-N.Y.) said in an April 7 letter to the Federal Emergency Management Agency that FEMA’s “opaque and evolving processes” for distributing materials for the COVID-19 pandemic do not meet the needs seen in some locales. The letter referred to an April 6 report by the Office of Inspector General stating that a survey of hospital administrators suggested a lack of capacity and personal protective equipment needed to deal with the pandemic, and a consequent staffing shortage. The letter inquired into the role played by Jared Kushner, son-in-law of President Trump, in coordinating the distribution of items in the Strategic National Stockpile to cities and states in need of supplies.
FDA commissioner Stephen Hahn said in an April 7 statement that serological tests rely on the body’s development of antibodies to the SARS-CoV-2 virus and that the delay in development of those antibodies thus limits such tests. Consequently, Hahn said, serological tests cannot serve as the sole basis for determining a patient’s health status, but that the agency has granted an emergency use authorization for only one such tests. Despite that, he said some test makers are claiming that their tests are FDA-approved or authorized, and Hahn said the agency will take the appropriate action.
The FDA granted an emergency use authorization to Inbios International Inc., of Seattle, for the company’s qualitative polymerase chain reaction test for the SARS-CoV-2 pathogen. The scope of the EUA is limited to labs that are CLIA-certified to conduct high-complexity tests.
HHS reported the first contract for ventilator production rated under the Defense Production Act to Detroit-based General Motors (GM). The contract, valued at $489.4 million, is for 30,000 ventilators slated for delivery to the Strategic National Stockpile by the end of August, with a production schedule allowing for the delivery of 6,132 ventilators by June 1. Last month, GM and Ventec Life Systems, of Bothell, Wash., said the former will build VOCSN, which stands for ventilation, oxygen, cough, suction and nebulization, critical care ventilators at GM’s Kokomo, Ind. manufacturing facility.