Dr. Mark N. Cohen, 2024 Copper Black Award winner

In 1973, while in medical school, Mark N. Cohen questioned the death of his favorite aunt a year earlier. She had died while undergoing an operation at another hospital, and no one could tell him why. Curious by nature, Cohen kept asking questions to find out what caused the loss of this incredible woman. Eventually, he found out her death was due to a defective product — one that the FDA had already recalled. Why was the hospital still using the recalled product? Cohen wondered plaintively.

Innovation makes medical miracles possible, but modernization also comes with risks. On average, about 4,500 drugs and devices are pulled from use each year. The recalled products have FDA approval and, in many cases, are widely ingested, injected, or implanted before being recalled.

Back in 1973, the lengthy recall process was a big problem for hospitals. Recalled devices and pharmaceuticals were often used on patients due to the slow turnaround for manufacturers to inform end providers of a recall. It was killing people. With unfortunate firsthand experience, Cohen launched the National Recall Alert Center (NRAC) that November, a nonprofit that would be a clearinghouse for recalled items. He opened an office near Washington, D.C., and the FDA. And now, more than 50 years later, the NRAC remains the premier medical recall warning system protecting hospitals, staff, and patients. Facilities trust the organization to minimize their liability, guarantee compliance, and prepare them for survey or audit examiners and inspectors. Every day, the system protects about 500,000 patients from the potential harm of recalled medical products.

The impact of Cohen’s NRAC cannot be overestimated. The organization says it has an unblemished record of never missing a product recall or exposing a member hospital to any legal situation.

The key to its success lies in its ability to connect more than 30,000 global medical product manufacturers with about 4,160 hospitals — roughly 80 percent of U.S. hospitals — for the efficient communication of recall information. The system integrates artificial intelligence to perform its critical functions. Beyond merely informing hospitals about recalls, the NRAC helps manage the recall process. This includes matching recalled products against hospital inventories and purchased histories, ensuring no recalled items remain in use.

“I have dedicated my life to this cause, foregoing a career in medicine to focus on enhancing patient safety on a national scale,” said Cohen, a Life Member with Delaware Valley Mensa. “The result of this dedication is a system that has become an integral part of the U.S. health care infrastructure, contributing to the well-being of millions of patients annually.”

The Copper Black Award for Creative Achievement is not given for the creativity of a person, but for a specific creative achievement that may include an invention that has been patented or otherwise demonstrated to be of practical value, or an innovation that has been implemented, at least in part, to the advantage of persons other than the nominee.