Regulations Stymie COVID-19 Innovation
Amid a nationwide ventilator shortage, hospitals are facing increasing pressure to make difficult decisions. In preparation for such a shortage one doctor at the University of Mississippi Medical Center, Charles Robinson, had an idea to build the “absolute simplest, cheapest functioning ventilator from widely available parts.”
“The Robertson Ventilators are made from garden hose sections, adapters, valves, a solenoid and a lamp timer, all of which can be bought at a hardware store or online. The parts cost less than 100 dollars per ventilator and can be assembled in less than an hour. The ventilator works when plugged into the standard oxygen line in a hospital room, meaning it can be used in more locations than a standard ventilator.”
Dr. Robertson and his team designed and build 170 of these ventilators, more than doubling the hospital’s supply. The ventilators have been extensively tested and are ready for use, but until the FDA approves an Emergency Use Authorization the life‐saving equipment will sit idle.
Critically ill patients may not have the luxury of time. The FDA has already contributed to the severity of the pandemic by delaying approval of coronavirus tests. The FDA’s mission statement claims, in part, that they are, “responsible for advancing the public health by helping to speed innovations.” But so far during this pandemic we have seen significant bureaucratic obstacles and costly delays. The sooner this stops, the better.
Amid a nationwide ventilator shortage, hospitals are facing increasing pressure to make difficult decisions. In preparation for such a shortage one doctor at the University of Mississippi Medical Center, Charles Robinson, had an idea to build the “absolute simplest, cheapest functioning ventilator from widely available parts.”
“The Robertson Ventilators are made from garden hose sections, adapters, valves, a solenoid and a lamp timer, all of which can be bought at a hardware store or online. The parts cost less than 100 dollars per ventilator and can be assembled in less than an hour. The ventilator works when plugged into the standard oxygen line in a hospital room, meaning it can be used in more locations than a standard ventilator.”
Dr. Robertson and his team designed and build 170 of these ventilators, more than doubling the hospital’s supply. The ventilators have been extensively tested and are ready for use, but until the FDA approves an Emergency Use Authorization the life‐saving equipment will sit idle.
Critically ill patients may not have the luxury of time. The FDA has already contributed to the severity of the pandemic by delaying approval of coronavirus tests. The FDA’s mission statement claims, in part, that they are, “responsible for advancing the public health by helping to speed innovations.” But so far during this pandemic we have seen significant bureaucratic obstacles and costly delays. The sooner this stops, the better.
. maybe they are taking long because after decades of gutting funding maybe they are overwhelmed with all these new products requesting approval and have to review them.