The previous year, the Centers for Disease Control had released a study, subsequently published in the New England Journal of Medicine, linking pregnant women’s deaths to the Dalkon Shield intrauterine device (IUD). The reason why Apple Watches are not available to fill some of this gap traces to 1976-about one month after Steve Jobs, Steve Wozniak, and Ronald Wayne founded Apple-when Congress passed the Medical Device Regulation Act. Delivery dates on Amazon are already backed up for weeks. Like other items, from toilet paper to surgical masks, they’re unlikely to be widely available in a pandemic, when everyone wants a device and public demand outpaces manufacturing and distribution capability. Relatively inexpensive pulse oximeters remain widely available-usually. Yet the Apple Watch currently on the market cannot make this feature available to the consumer. The plethysmograph in the Apple Watch that measures pulse works essentially the same way. That sounds high-tech, but it’s an old technology, first developed for earlobes in the 1930s fingertip pulse oximeters were developed in Japan in the 1970s. Variations in absorption between the different wavelengths by arterial blood allow us to read oxygen saturation. Pulse oximetry refers to the measuring of blood oxygenation noninvasively, by firing wavelengths of light-red and infrared-through the skin. By the time most patients made it to the hospital, they had “remarkably low oxygen saturations.” Levitan’s recommendation: “Widespread pulse oximetry screening an early warning system.” Levitan had seen many cases of “silent hypoxia,” unknown oxygen deprivation in which “patients without respiratory complaints had Covid pneumonia”-even those admitted to the hospital for non-Covid-related health concerns. On April 20, emergency-room doctor Richard Levitan described in the New York Times what he’d observed treating patients in Bellevue Hospital in New York. It’s another example of how federal regulation of the production and distribution of pharmaceuticals and medical devices in the United States is less focused on stopping viruses and other diseases than on blocking private-sector innovators from developing solutions that may not work or might have harmful side effects. Under current FDA regulation, the function is disabled. It also contains hardware to measure your blood-oxygen levels, and it has been doing so since the watch was released-but the hardware is not operable by the watch’s wearer, who thus cannot obtain the results. Among its many features, the Apple Watch can take your pulse. Millions of Americans own an Apple Watch, which commands roughly a 50 percent share of the smartwatch market.
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