Shortly after FDA Commissioner Scott Gottlieb announced his resignation, Kaiser Health News dropped a bombshell story about non-publicly-accessible “exemptions” reports for devices like surgical staplers – and then the agency appeared to acknowledge the scope of the issue in an FDA stapler-related action announcement.
The gist of the KHN story
centers on “exemptions reporting” for devices, and goes into some detail about the injuries and the legal ramifications that have occurred with some. The report highlights cases involving surgical staplers, pelvic mesh, the da Vinci surgical robot, the through-the-blood vessel heart valve Sapien 3, and the heart-flap-attacher MitraClip.
The exemptions allow for reporting multiple similar episodes of injuries or deaths on a single report, making it easy for a reviewer to think the report covers a single episode. Here is an example from the KHN story
of one such report that aggregated over 1,300 da Vinci surgical system “initial events” into a single Manufacturer and User Facility Device Experience (MAUDE) filing.
The way it works, according to KHN, is that “under what the FDA calls the 'litigation complaint summary reporting' exemption, device makers can file a single 'injury' report. Attached to the summary, report makers add a spreadsheet that can contain thousands of reported patient injuries alleged in lawsuits.”
And that spreadsheet is hard for the public, including healthcare professionals, to get.
“More than a million reports of malfunctions or harm spanning about 15 years remain in a database accessible only to the FDA. But with the agency’s new transparency push, the public may find a public report and submit a Freedom of Information Act request to get information about incidents. A response can take up to two years,” according to the story, and FDA data crunched by KHN, it was revealed that “from 2014 through 2017, the overall number of alternative summary reports [for injury reports] filed by device makers rose from 431,000 to 481,000.”
Pittsburgh surgeon Dr. Douglas Kwazneski, who had a stapler failure during an operation, was baffled when he couldn't find similar episodes in FDA data bases, especially when colleagues shared similar experiences – resulting in a survey on reporting problems, which he published in Surgical Endoscopy
. “I don’t want to sound overdramatic here, but it seemed like a cover-up,” Kwazneski told KHN.
But an FDA official said the exemptions are for issues “well-known and well-documented".
Agency spokeswoman Deborah Kotz told KHN by email that there was no public notice or regulations for the “registry exemption” and that “any device manufacturer can request an exemption from its reporting requirements.”
Another FDA spokeswoman, Alison Hunt, told KHN that the “majority of exemptions” have since been revoked, and now a report is publicly filed and the program allows “the FDA to more efficiently review adverse events … and take action, when warranted, without sacrificing the quality of our review or the information we receive.”
The KHN story came out on March 6 and was shortly followed on March 7 by an FDA announcement
that it was launching new actions aimed at addressing the surgical stapler concerns, and appeared to acknowledge the existence of the non-public reports' potential for problems.
“We are aware that many more device malfunction reports during this time frame (from January 1, 2011 to March 31, 2018) were submitted as Alternative Summary Reports. We are conducting an ongoing analysis of both these reports and of medical device reports received since March 31, 2018. The results of this analysis, when complete, will be available to the public along with the materials for the upcoming advisory committee meeting. These devices are not currently eligible for alternative summary reporting or Voluntary Malfunction Summary Reporting,” the FDA said in its statement, referring to the staplers.
It also stated that, “our analysis, which is ongoing, found that from January 1, 2011 to March 31, 2018, the FDA received over 41,000 individual medical device reports for surgical staplers and staples for internal use, including: 366 deaths, over 9,000 serious injuries, and over 32,000 malfunctions.”
The agency also announced its intention to issue “a draft guidance for public comment in 2019 concerning product labeling information,” and hold an open public meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee to weigh reclassifying staples as Class II devices, which “would allow the FDA to establish mandatory special controls and require premarket notification (510(k)).”