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Most Medical Device Recalls are Caused by Software Glitches


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A report published earlier this month by Stericycle Expert Solutions, a U.S. company that manages product recalls, highlighted how problems with software resulted in a significant number of recalls of medical devices during the final three months of 2018. This reason mirrors what has been recorded during previous quarters by the company in their “recall index”.

The authors of this report compile data regarding the cause and frequency of recalls for a variety of products sold in the United States including automotive, food, consumer, and pharmaceutical products in addition to medical devices.

They obtain the data from a variety of government sources including the National Highway Traffic Safety Administration (NHTSA), the U.S. Department of Agriculture (USDA), the Food and Safety Inspection Service (FSIS), the Food and Drug Administration (FDA) and the Consumer Product Safety Commission (CPSC).

There were 280 medical device recalls logged during the final quarter of 2018. Although this marked a reduction of 1 percent over the number of recalls that happened during the previous quarter, there were still 161 million units found to have defects. This means that the number of recalls that took place during the final three months of 2018 was the second-highest there’s been in the past decade.

Of the nearly 280 recalls that occurred during the final months of 2018, an average of 575,500 devices were affected per quarter. Just over 100,000 devices were affected by each recall during the third one last year.

Reasons for Medical Device Recalls: Software Issues

The reasons for the recalls have remained much the same for the past eleven quarters. At least 28.2 percent of them were caused by software issues. Another 15.4 percent resulted from concerns about how they were labeled. The third most common cause that resulted in 12.9 percent of the recalls were quality concerns.

Medical devices are often implanted in patients in Houston to help improve their overall health and well-being. Defective ones have a way of causing irreversible medical problems and even a patient’s potential death. One of the only ways to stop manufacturers who put consumers at risk is to have a skilled defective medical devices attorney step in and file suit against them for the problems that they’ve caused.

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