The U.S. Food & Drug Administration (FDA) has formally ended the Alternative Summary Reporting program, a system that previously concealed thousands of surgical stapler injuries and other device complications from public view.
The end came last Friday, when the agency issued revocation letters to the remaining 13 manufacturers granted exemptions under the program. The companies’ exemptions covered three types of medical devices: dental implants, implantable cardiac defibrillators and pacemaker electrodes.
That same day, the FDA publicly posted all data submitted to the Alternative Summary Reporting program from 1999 to 2019.
The Alternative Summary Reporting exempted medical device manufacturers from publicly disclosing certain “well-known events associated with specific devices,” such as those noted on product labels. The FDA had granted 108 individual exemptions to medical device companies during the program’s existence. Once exempted, manufacturers were only required to report adverse event summaries to the agency on a quarterly basis.
The program made news in March, when Kaiser Health revealed that it had logged a stunning 1.1 million adverse event reports since 2016. Internal surgical staplers were among the exempted devices that appeared to be linked with wide-spread reports of patient harm.
A month later, the FDA acknowledged that the Alternative Summary Reporting program had received around 56,000 reports of surgical stapler injuries and malfunctions from 2011 through 2018. When those reports were added to others collected by the publicly-available MAUDE database, the number of adverse events associated with internal surgical staplers ballooned to more than 110,000.
Surgeons use internal surgical staplers to cut tissue, remove organs, and create connections between structures during a variety of thoracic, gynecological, and gastrointestinal procedures. According to the FDA, some of the most commonly reported problems associated with their use included:
Surgical stapler injuries and malfunctions may prolong procedures or result in the need for additional surgical interventions, either of which increased the risk for serious and life-threatening complications, such as:
The FDA currently classifies internal surgical staplers as Class I (low risk) medical devices. In April, however, the agency proposed moving the devices to Class II, or moderate risk. Doing so would allow the FDA to require premarket review and establish special controls to ensure their safety and effectiveness.