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The Current Landscape at the Epicenter The war against the novel coronavirus disease 2019 (COVID-19) continues as we write this from a busy New York City hospital on April 5, 2020. At the time of this writing, 1,237,420 positive cases and 66,560 associated deaths have been confirmed in 183 countries 1. For perspective, when the World Health Organization (WHO) declared COVID-19 to be a global pandemic on March 11, 2020 (just over 3 weeks ago), there were 118,000 positive cases and 4,292 associated deaths in 114 countries 2,3. In our hospital system today, there are currently 2,200 patients who have tested positive for the virus. Of these patients, 613 (27.9%) remain in intensive care units (ICUs), with approximately 95% of the 613 requiring mechanical ventilatory support. The COVID-19 pandemic has significantly taxed the resources at our hospital.

When orthopaedic surgeons are considering using a new device clinically in their patients, it is important for them to consider how the new device was approved by the FDA. If the device was approved by the 510(k) pathway, then it may have been approved without additional clinical studies confirming efficacy or safety.

Therapeutic Level IV. See Instructions for Authors for a complete description of levels of evidence.