An op-ed by Patrick Hope

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.
In medicine, not knowing what we don’t know can have devastating consequences — but for problems we do know about with easy solutions, like ensuring proper oversight of remanufacturing, it is imperative for Congress to act. The Clarifying Remanufacturing to Protect Patient Safety Act of 2022 (H.R. 7253) would clarify the definition of remanufacturing as it relates to medical devices to better protect patients by helping educate those who work on these complex medical devices about where the line is for these activities, and ensure they fall under proper FDA oversight.

Here is what this legislation is not. This bill does not change how remanufacturing itself is regulated. Rather, it clarifies remanufacturing in a way that removes ambiguity about which device maintenance activities are of the most concern. The bill maintains remanufacturing is an activity that “significantly” alters how a device functions but provides more concrete examples of what type of activities fit that definition. By doing so, this bill creates transparency for all actors and helps to prevent potential risks from medical device safety or performance changes that happened previously without proper oversight or accountability.

The bill also provides for public education measures to raise awareness of safety concerns and allows responsible actors to come into compliance and put patient safety first. This means responsible parties are given clarity to address existing confusion, and the FDA is given authority to act in the best interest of patients.

HTM Homepage