Here Is How the FDA Made the RSV Wave More Dangerous
Forget Covid-19 and Monkeypox. Respiratory syncytial virus (often shortened to RSV) may be the biggest public health threat this season. RSV is a virus that often results in mild cold-like symptoms for many infected adults. However, it can be deadly for children. RSV is estimated to be responsible for 1 out of 50 children’s deaths globally and 1 out of 56 deaths for children in developed countries.
RSV is rapidly spreading across the US and threatens our youth. The Center for Infectious Disease Research and Policy at the University of Minnesota reports the highest hospitalization rates for flu (including RSV) in a decade—with children and seniors most affected. California recently reported its first RSV complications-related death for a child. Fearing the worst is yet to come, Colorado Governor Jared Polis signed an order extending the Covid-19 emergency declaration to include RSV and other respiratory viruses. Governors in other states could follow his lead.
The younger the patient, the more difficult RSV is to treat. Infants with RSV cannot safely use most medications to treat the virus’s symptoms. Because infants are particularly susceptible to developing bronchitis or pneumonia from RSV, carefully monitoring breathing patterns is vital.
There are very few devices that effectively monitor an infant’s oxygen levels, and many of them are only found in hospitals. There used to be one widely available to parents until the Food and Drug Administration ordered it off the market.
Nearly a year ago, the FDA sent a warning letter to Owlet regarding its Smart Sock—a product that monitored an infant’s pulse and oxygen intake. The letter stated the FDA determined the Smart Sock is a medical device that needed to undergo the agency’s approval process before reaching the market. At the time, Smart Socks had been on the market for five years, boasted a 90 percent accuracy rating according to peer-reviewed research, and helped over 600,000 parents care for their children.
Unable to undergo the time-consuming and expensive process, Owlet released a version of the Smart Sock this January. But the latest version no longer monitors an infant’s heart or lungs. Consequently, the FDA drove parents’ best option to carefully monitor their baby’s vital organ function off the market.
In an article I wrote for the American Institute for Economic Research shortly before the Smart Sock was pulled from store shelves, I warned, “The cost of the agency’s decision is hundreds of thousands of infants going without a highly reliable monitoring device and countless sleepless nights for parents fearing for their children’s health or life.” As RSV sweeps across the country, there will be tragically more of both.