FDA on Friday unveiled a sweeping plan to improve surgical stapler and implantable staple safety after a Kaiser Health News (KHN) investigation published Thursday revealed FDA's internal database contains thousands of stapler-related adverse event reports.
Device manufacturers avoid publicly disclosing malfunctions by using FDA exemptions, KHN finds
The KHN investigation focused on an FDA policy that allows medical device manufacturers to privately submit certain malfunction reports as "summary reports." Those reports are disclosed to FDA, but according to KHN they are not disclosed in the agency's public database called Manufacturer and User Facility Device Experience (MAUDE). FDA spokesperson Deborah Kotz confirmed that the agency created the "registry exemption" without any public notices or regulations. Kotz said, "Any device manufacturer can request an exemption from its reporting requirements."
After reviewing FDA records and interviewing former and current FDA officials, KHN found manufacturers have reported at least 1.1 million incidents spanning about 100 medical devices—including balloon pumps, mechanical breathing machines, and surgical staplers—to FDA's alternative summary reporting database. An FDA official told KHN the alternative summary reporting program is exclusively intended for issues that are "well-known and well-documented with … FDA."
But KHN's investigation showed FDA's summary reporting database received about 10,000 stapler malfunction reports in 2016—and doctors and researchers who rely on publicly available data to gauge medical device safety and risk were largely unaware those reports existed.
FDA raises concern about surgical stapler and implantable staple safety
In a letter to providers Friday, FDA said it had launched an ongoing review of medical device reports submitted for both surgical staplers and implantable staples, and based on the initial data it is "concerned" about an increase in the number of adverse events linked to the devices.
The agency reported that from Jan. 1, 2011, to March 31, 2018, it received more than 41,000 individual reports of problems with surgical staples and implantable staples, including 366 deaths and more than 9,000 serious injuries. According to FDA, that figure does not include the device malfunction reports that were submitted as alternative summary reports. The agency said it will continue to review medical device reports and alternative summary reports submitted beyond March 31, 2018, and will publicly share the results when completed.
FDA's plan to improve safety
In the meantime, FDA said it will hold a public advisory committee meeting this year to discuss whether FDA should reclassify surgical staplers as Class II medical devices—which require a premarket notification and would allow FDA to establish controls to reduce risks associated with the device. Surgical staplers currently are Class I medical devices, which do not require a premarket submission to the FDA.
FDA also said the agency plans to release draft guidance proposing what manufacturers of surgical staplers and staples should include on their product labels.
Until then, FDA advised physicians to "carefully follow the stapler manufacturer's instructions for use" and "[h]ave a range of staple sizes available and select the appropriate size cartridge for the tissue type and thickness."
William Maisel, CMO in the FDA's Center for Devices and Radiological Health, said, "Improving the safety of surgical staplers and implantable staples is a top priority for the FDA, and [FDA] believe[s its] forthcoming draft guidance to industry and planned advisory committee meeting will advance those efforts" (Gever, MedPage Today, 3/8; Jewett, Kaiser Health News, 3/8; Jewett/de Marco, Kaiser Health News, 3/7; Owens, "Vitals," Axios, 3/11; FDA release, 3/9; FDA letter, 3/9).
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