8/14/20
Surgical gowns, gloves, masks, certain ventilators and various testing supplies needed to respond to the coronavirus pandemic are on the FDA's first-ever list of medical devices in shortage. The shortage list was released hours after President Donald Trump touted the progress his administration has made in securing critical protective gear and other supplies. "We have tripled the number of N95 masks on hand to over 40 million, tripled the number of gowns to over 15 million and quadrupled the number of ventilators to 69,000," Trump said at a briefing on Friday, referring to the country's Strategic National Stockpile. But health care workers at smaller and poorer hospitals and medical systems say they are still struggling to obtain protective gear, personnel and resources to fight the coronavirus. Trump has also repeatedly described the United States' testing system as the best in the world. Premier, a group purchasing organization, praised the FDA for publishing the list, saying the action “is a positive development that will enable greater resiliency in the healthcare supply chain.” FDA laid out reporting requirements for device manufacturers in May. The agency expects industry to alert the agency at least six months in advance of discontinuance or interruption of critical devices. The FDA previously has said it will work with Congress to expand device manufacturer shortage disclosure requirements.