The Food and Drug Administration carefully polices many categories of drugs and devices. But when it comes to software, the agency’s oversight is scanty at best — something that a new study finds is resulting in failure to detect dangerous glitches in software-enabled medical equipment.
The study comes amid ongoing debate over the FDA’s role in reviewing the booming number of software-enabled products in health care.
The study, published in Milbank Quarterly, found that 11 of the 12 software devices subjected to the highest-risk recalls between 2011 and 2015 went through a streamlined review process, known as 501(k), that didn’t require testing for safety and efficacy. The other one was completely exempted from review.
Those recalls included life-sustaining equipment such as ventilators and infusion pumps, as well as a clinical decision support software used to flag adverse drug events during surgery.
“The FDA is allowing many of these products on the market with relatively loose criteria of what is acceptable, and those are the ones that are most likely to end up causing harm,” said Diana Zuckerman, a co-author of the study and president of the National Center for Health Research.
In a response to STAT questions, a spokeswoman for the FDA acknowledged that its review process needs to be updated to reflect issues posed by software-enabled devices.
“FDA’s traditional approach to medical devices is not well-suited to these products,” the spokeswoman, Stephanie Caccomo, wrote in an emailed statement. “A new pragmatic approach must recognize the unique characteristics of digital health technology and the marketplace for these tools, so we can continue to promote innovation of high-quality, safe, and effective digital health devices.” […]
Errors and glitches
The study examined 627 software devices recalled over the five-year period between 2011 and 2015. Most of the recalled devices (592) were classified as presenting moderate risk; 23 were classified as low risk; and 12 were deemed high risk.
The high-risk recalls involved equipment used in several different settings. Six of the devices were used in anesthesiology, including five ventilators and one decision support tool. The study reported that the software glitches in the ventilators could cause them to stop working prematurely. The decision support tool, used to flag adverse drug events in surgery, could lead to the use of the wrong patient’s data during a procedure. […]
The impact of Cures Act
The debate over the FDA’s scrutiny of medical software and digital health products is also being played out through implementation of the 21st Century Cures Act, which includes a provision that exempts certain software devices from the agency’s jurisdiction. Zuckerman said the exemption is a step in the wrong direction at the worst possible time, when rapid innovation is producing increasingly complex devices that require deeper scrutiny.
“Our Congress should not have passed a law lowering standards in a way that could be so harmful to patients,” she said. […]
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