The FDA published an executive summary report this week revealing that more than 56,000 surgical stapler malfunctions were concealed from the public between 2011 and 2018 using a hidden database, according to Kaiser Health News.
Five things to know:
1. Under a program known as "alternative summary reporting," medical device manufacturers could apply for an FDA exemption to prevent specific incidents from going on the public FDA database. Instead, they went to a hidden, internal FDA database. The FDA recently announced it will end the program that allowed devicemakers to conceal reports of device-related harm and malfunctions from the public and physicians.
2. In an executive summary report published this week, the FDA said that more than 110,000 malfunctions or injuries resulted from surgical staplers between 2011 and 2018 when taking into account the nonpublic reports.
3. More than 50 percent of the 110,000 malfunctions were nonpublic reports.
4. As a result of the findings, an FDA panel recommended switching surgical staplers to a higher-risk classification, which would add safety requirements.
5. More than 400 deaths have been linked to surgical staplers since 2011. Deaths must be made public, so they can't be reported to the alternative summary reporting database.
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