Presidential Action Reported by Bloomberg Law
The Trump administration is expected to soon direct how manufacturers will distribute crucial medical supplies — including protective gear and ventilators — to combat the coronavirus outbreak. Read story here.
Healthtrust has a unique perspective on the global supply chain given our sourcing presence in China and the UK, and our participation on government-led task forces and industry initiatives. Our sources have confirmed government plans to send aircraft, beginning this weekend, to secure critical PPE items from Mexico and Shanghai. We are told that multiple 747s will be used to bring product to the U.S., 50% of which will be deployed to hot spots in New York, Los Angeles and Washington State. The balance of inventory will be distributed through mainline healthcare distributors. While specific items and quantities cannot be confirmed, the aircraft capacity suggests very timely relief to a supply chain under siege in several areas.
In addition, the government has directed N95 mask production to be dedicated solely to the healthcare sector. Expedited FDA approval is expected for manufacture of N95 industrial masks for emergency use. Critical shortages will should begin to abate as early as next week. As we learn more, we will use share details in a future Flash Update.
FDA outlines steps to facilitate access to crucial medical products, including ventilators. In a March 3rd update, the FDA recommended removing the premarket review on modification of specific devices; resourcing ventilators intended for other environments (anesthesia machines and transport ventilators); use of CPAP and/or BiPAP machines to treat patient with respiratory insufficiency (provided that mitigations are in place to minimize aerosolization); and continued use of ventilators beyond the indicated shelf life. Find the FDA summary here.
A rapid, point of care diagnostic test for the detection of the 2019 novel coronavirus that causes COVID-19 has received FDA emergency use authorization. Xpert® Xpress SARS-CoV-2 from Cepheid is an automated molecular test for the qualitative detection of SARS-CoV-2 that leverages cartridge technology in which multiple regions of the viral genome are detected. The test can provide rapid detection in approximately 45 minutes with less than a minute to prepare the sample. This is one of several diagnostic companies that have been approved by the FDA via Emergency Use Authorizations (EUA) for medical devices. More can be found here.
Gilead Sciences has temporarily stopped granting COVID-19 patients access to remdesivir (its experimental drug originally developed for the Ebola virus), citing “overwhelming demand.” Gilead has made it possible for patients at high risk to get the drug through compassionate use with access provided to several hundred patients in the United States, Europe and Japan. Remdesivir is being studied in five large clinical trials, two of which could provide results as soon as April, but definitive results and use against the SARS-CoV-2 virus remain to be determined.
Hydroxychloroquine and Chloroquine, used to treat malaria and certain autoimmune diseases, have demonstrated potential use against the SARS-CoV-2 virus in vitro by increasing endosomal pH needed for viral replication. Hydroxychloroquine in combination with azithromycin was reported to potentially be effective in a small study from Italy. This study included 36 patients who were SARS-CoV-2 positive, but a few were asymptomatic. The authors were investigating the impact of Hydroxychloroquine therapy on the reduction of viral carriage after 6 days of therapy. Some reduction in viral load was noted, but this was not a controlled clinical trial and further study is necessary to determine if these agents are truly useful in treating COVID-19.
Given the surge in utilization of PPE, supply chain leaders are deploying conservation measures wherever possible. If you have implemented the practices below, know that to sustain your efforts, it is imperative that you continually monitor and communicate your facility’s guidance concerning PPE requisitioning, utilization, distribution and control. Absent diligent efforts in this regard, you may see staff reverting back to their former practices. Centralize the receipt and storage of PPE. PPE is a precious commodity. Assuring that it is secure to prevent hoarding or theft by staff and visitors is essential. Consider setting up a centralized and secure location with limited access, and removing all PPE from public areas, corridors and exam rooms. Control the ordering and requisitioning of PPE only to authorized and appropriate departments. Supply chain can assist with establishing and communicating interim requisitioning processes and communicating usage guidelines to staff. Consider temporarily removing PPE items from the item master. Appoint a PPE leader to manage distribution and allocation. This role should liaise with clinical teams to understand usage guidelines, assign prioritization and allocation, educate clinicians on conservation methods and ensure product gets to the sites with the greatest need.
IMPORTANT NOTICE: The content in this communication is provided for informational purposes only and intended for its direct recipients. Due to the urgent and dynamic nature of the COVID-19 pandemic, the potential member best practices, experimental techniques, and other materials herein may be preliminary, evolving and subject to change. Nothing herein is intended to replace health system practices and independent clinical decision-making, which are the sole responsibility of systems and their practitioners. HealthTrust, on behalf of itself and any members that have provided this content, expressly disclaims any liability for health system operational and treatment decisions.
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