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Latest From Sue Darcey
The US FDA wants to expand the availability of surgical apparel – including gowns, hoods and examination gloves – for health care professionals to use for the duration of the COVID-19 public health crisis. That means the agency will “not object” to the use of gowns and gloves providing low-to-minimal protection, as long as they do not create an undue risk to patients or users.
A $2.2tn coronavirus stimulus package signed into law by President Trump on 27 March will distribute billions of dollars to federal agencies – including the FDA, the CDC and the FEMA – to hasten approvals of new diagnostics, medical ventilators, respirators and other medtech supplies, conduct more testing of potential COVID-19 patients, and quickly distribute medical supplies where needed most.
Medical device industry advocacy group AdvaMed sent a letter on 24 March to FEMA administrator Peter Gaynor asking for US centralization of the medical ventilator procurement and allocation process. The goal is to ensure that the ventilators are distributed where they’re needed most during the coronavirus pandemic.
A telehealth toolkit released by the US Medicare agency on 23 March targeted to end-stage renal disease providers explains how Medicare can reimburse for office, hospital and other telehealth visits with kidney disease patients during the coronavirus public health emergency.
The US agency says it will not object to medtech manufacturers making minor modifications to the motors, tubing or software of medical ventilators – or even to pressing CPAP (continuous positive airway pressure) equipment into service to use as ventilators – during the COVID-19 public health emergency.
A $5bn emergency fund reimbursing US clinical laboratories for scaling up COVID-19 testing with lab-developed tests must be part of a $1tn Senate coronavirus aid and relief package, clinical lab group ACLA says. Other provisions already included in the draft bill address stockpiling of testing swabs, liability protection for medtech firms, a requirement for device makers to report supply chain shortages, the expanded use of telehealth, and preventing durable medical equipment payment reductions.