Mistakes happen. It’s a fact of life. However, across all aspects of American life, regulations exist to balance the risk of mistakes with the severity of outcomes. When clear, simple uncontroversial measures have the potential to save lives, we expect policymakers to act swiftly.

Such is the case with medical device remanufacturing. In a 2018 report, the U.S. Food & Drug Administration (FDA) concluded that a majority of reports alleging that inadequate “servicing” caused or contributed to adverse events and deaths actually pertained to “remanufacturing” not “servicing.” These egregious remanufacturing activities had escaped oversight, in large part, due to confusion about where the line between servicing and remanufacturing is. In other words, inadvertent mistakes resulting from unclear regulations.

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