National Center for Health Research, May 30, 2019
General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Meeting
National Center for Health Research’s Public Comments on the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee Request for Comments
Good afternoon. I’m Jack Mitchell, Director of Health Policy for the National Center for Health Research. NCHR is a non-profit think tank that conducts and analyzes research with implications for public health, including the safety and effectiveness of medical products. We accept no money from the pharmaceutical or medical device industries and I have no conflicts of interest.
NCHR strongly supports FDA’s Draft Guidance to Reclassify from Class I to Class II certain surgical staplers for internal use. We believe that the agency has uncovered more than sufficient evidence in its review to make such a reclassification absolutely necessary, and overdue. Medtronic says that it agrees with the upgrade, so perhaps there is not as much to debate as perhaps expected,
In March, Kaiser Health News published a disturbing expose entitled “Hidden FDA Reports Detail Harm Caused by Scores of Medical Devices.” This article revealed that the number of serious adverse events reported for surgical staplers prior to 2017 was much higher than previously known to physicians, surgeons, or the public. In fact, many thousands of such adverse event reports had been hidden from the public in an FDA database containing what agency officials referred to as the “registry exemption”.
Under this previously little-known policy, a medical device manufacturer could apply to FDA to file thousands of adverse reports in summaries that were not available to the public. Dozens or even hundreds of these adverse events were sometimes bundled into one single report, or a few reports. In 2016, according to the article, only 84 injuries or malfunctions were identified in the public data base as being attributed to surgical staplers, or staples used in them.
Meanwhile, nearly 10,000 additional stapler-related malfunctions were included in the non-public database, according to information FDA provided to Kaiser Health News. The article also quoted a former FDA Commissioner as stating he was unaware of the non-public data base device reporting program.
The ten thousand reports included serious injuries caused to patients by malfunction or misuse of surgical staplers. These harms included critical adverse events such as life-threatening sepsis infections, tearing of tissue and internal organs, and staplers that malfunctioned during surgery.
Since Class I devices are defined as “low risk”, such potentially fatal medical calamities are clear evidence that staplers need to be up-classified to Class II. Ethicon recently announced a recall of thousands of its circular surgical staplers for malfunction under a Class I recall, the most serious category of recalls.
The initial purpose of the summary reporting may have been to legitimately reduce unnecessary paperwork for both industry and FDA. Nevertheless, the National Center for Health Research agrees with the criticism of numerous medical experts and physicians, upon learning that FDA had kept information from the public about hundreds of thousands of injuries and malfunctions involving surgical staplers and many other medical devices.
FDA said it has revoked permission for some summary reporting in February has reportedly moved to end this controversial reporting program, and indicated the agency may make old reports publicly available, perhaps within a few weeks. For many patients, the damage already has been done.
Surgical staplers are a necessary, daily part of hospital operations, and can be a lifesaving device in many instances. But as we now know, they malfunction or cause serious problems far too often to remain in a regulatory class with cotton swabs, tongue depressors, and crutches.
These devices are invasive and require better safeguards. We urge the Committee to determine whether the special controls under the 510(k) program—a pathway that does not require clinical trials or direct evidence of safety or effectiveness—would be sufficient to adequately protect patients from defective devices.
I should note that in 2011 the Institute of Medicine (IOM), now the National Academies of Sciences, concluded in a bluntly-worded report that the 510(k) system established neither safety nor efficacy. The IOM report strongly recommended to FDA that the agency discard or scrap the 510(k) pathway and replace it with a more rigorous approval system. The FDA rejected those recommendations and made only minor changes to the 510(k) pathway to approval. The 510(k) system is no panacea.
I respectfully ask you to recommend that the FDA reclassify surgical staplers intended for internal use as Class II medical devices. Please also consider what else is needed to ensure that all such staplers—and surgical staples used in them—are as safe and effective as possible.
Thank you for the opportunity to speak.
The National Center for Health Research can be reached at email@example.com.