2018 has seen more medical device recalls than any previous period. There have been 343 device recalls in the first three months of the year, an increase of 126 percent over the last quarter of 2017, according to the report from data company Stericycle Expert Solutions.
The increase in recalls is not limited to medical devices however. There were 105 prescription drug recalls, an increase of 52 percent and the highest number since 2013.
One industry expert believes that the increase is just the tip of the iceberg and that we are not aware of many problems that go unreported or underreported. “My concern is this report is just showing us the tip of the iceberg, and there are a lot more adverse events associated with devices on the market that we’re not hearing about and should be,” said Dr. Rita Redberg, a cardiologist at University of California San Francisco, who has done extensive research in the area of medical device safety.
The total number of medical device units recalled in the quarter was about 208.4 million, with the average number involved in each recall being 607,512, according to the report. The vast majority of the units – 93.7 percent – were recalled due to manufacturing defects.
What’s Causing the Increase?
Software problems were the top cause for the recalls. A total of 22.7 percent of recalls were for that reason. It was the eighth quarter in a row that software was the top reason for device recalls.
Redberg believes the culprit is the adverse event reporting system established to track and identify problems with devices and drugs. “My sense, even before the report, is that things are worse because there has been little attention paid to recording adverse events, to look at post-market surveillance,” she said, referring to research done after a device is being used on patients. “There is a lot of attention being paid to getting devices on the market faster.”
The 21st Century Cures Act, passed in December 2016, allows for reduced reporting of adverse events as well. Redberg cites one example to make her point-the implanted cardiac monitor, AngelMed Guardian. In 2018, an FDA advisory panel unanimously rejected the device, finding that the benefits didn’t outweigh the risks.
A majority of the panel voted that there was not reasonable assurance that the device was safe, while the entire 12-member panel found it not effective. But last month, the FDA approved the device, saying additional analysis “demonstrate a positive risk-benefit profile for the device.”
The reasons for the approval, Redberg said, are “unclear to me.” She said, “A lot of people rushed to the emergency room” when the device alerts went off for no reason.
The fact that there is a dramatic increase in adverse events associated with medical devices and pharmaceutical drugs demonstrates we need more accurate and thorough analysis of these drugs and devices, not less. Yet, in spite of these facts, the federal government pursues an agenda that makes it easier to get these defective drugs and devices to market faster, not safer.
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