GAO Confirms Gaps in Device Reporting for Morcellators, Other Devices
The Government Accountability Office (GAO) has completed a long-awaited report that confirms serious gaps in FDA’s medical device reporting process that failed to identify adverse events associated with power morcellators used in removing uterine fibroids. Power morcellators had been on the market for more than two decades before the first report of their spreading undetected cancer was received in 2013 under the agency’s medical device reporting program, GAO finds.
The probe began in 2015 based on a request from 12 bipartisan members of congress, led by former Rep. Mike Fitzpatrick (R-PA) who has been putting pressure on FDA to focus more on medical device safety issues. Fitzpatrick had sided with activists Hooman Noorchashm and his morcellator-injured wife Amy Reed, both physicians, in seeking improved safety of 510(k)-cleared medical devices.
The GAO report finds that FDA had inspected 11 of the 12 manufacturers of power morcellator medical devices over the past five years, finding that they had not been reporting adverse events within required time frames or not implementing medical device reporting procedures. “For three manufacturers, the inspections resulted in FDA issuing Warning Letters that cited, among other things, violations of medical device reporting requirements,” the report says.
For user facilities like hospitals, the report notes that FDA inspected 17 hospitals 12/2015 that were chosen because there were reports of uterine cancer spreading from their use of power morcellators or reports of infections associated with their use of duodenoscopes. CDRH director Jeff Shuren was interviewed by GAO and he said that “while these events appeared to be the kind that would have fallen under the agency’s medical device reporting requirements, the agency did not see corresponding adverse event reports submitted to FDA’s adverse event report database,” the report says. He further said that from these inspections, the agency learned several things, including:
- “Some hospitals did not submit required reports for deaths or serious injuries related to devices used at their facilities; and in some cases, they did not have adequate procedures in place for reporting device-related deaths or serious injuries to FDA or to the manufacturers. Based on the number of user facilities in the United States and the number of reports FDA receives, the agency believes that these hospitals are not unique, in that there is limited to no reporting to FDA or to the manufacturers at some hospitals.
- “Hospital staff often were not aware of nor trained to comply with all of FDA’s medical reporting requirements.”
Shuren told GAO that the agency “wants to work with hospitals to address issues of limited or nonreporting, and to work with hospitals to get the real-world information FDA needs,” according to the report. “For example, following the inspections, FDA held regulatory meetings with certain hospitals to help identify corrective actions. In addition, FDA hosted a public workshop in December 2016 to discuss how to improve hospitals’ role in monitoring medical device safety.”
FDA officials also told GAO that due to limitations with current postmarket surveillance activities, it plans to generate better information in the future. “For example, in October 2016, the agency reported plans to work with hospitals to identify a system that quickly identifies life-threatening problems caused by medical devices,” the report says. “FDA officials also noted they will continue to review new technologies, such as morcellation containment systems, and work on a national registry to collect data on the treatment of fibroids. In addition, FDA is working to establish a National Evaluation System for health Technology to more efficiently generate better evidence for medical device evaluation and regulatory decision-making.”
Additionally, the GAO report found that 30 identified peer-reviewed articles published between 1980 and 2012 “mentioned or concluded a risk of tissue dissemination following the use of a power morcellator, or the need for a physician to remove all fragments of tissue following a surgery.” But it was not until 2014 that FDA took action after receiving a 2013 adverse event report from a patient (Amy Reed) — the first such report it said it had received.
Despite these articles having been received before the first official adverse event, FDA officials told GAO that, at the time, “there was no consensus within the clinical community regarding the risk of this occurring, particularly for cancerous tissue,” the report says. Most of the articles involved case studies or were limited in scope, agency officials told GAO.
Representatives Brian Fitzpatrick (R-PA) and Louise Slaughter (D-NY) released the following joint statement on the report:
“The release of this long-awaited report won’t do anything to help women battling cancer who have had their lives devastated by power morcellators, or provide much comfort to the families of those already lost. It does, however, shed light on the broken system that allowed this devastation to happen and include a roadmap to address it. The GAO report confirms what we had long expected: there are serious gaps in the FDA’s device reporting system and that immediate Congressional action is needed to reform the process and save lives. Additionally, given the associated risks, it's clear that this device is no longer appropriate in the treatment of uterine fibroids. Armed with this information, we will move forward to find bipartisan legislative solutions to address these shortcomings and ensure a system is in place that provides real, accurate information to patients, professionals and regulators.”
According to FDA officials interviewed for the report, 2,185 device inspections were conducted in fiscal year 2015, including 875 that audited medical device reporting compliance. “Of these inspections, FDA reported that the agency found 284 to have inspection observations related to medical device reporting requirements,” the report says.
After reviewing the report, morcellator activist Noorchashm said it “finds serious, and potentially deadly, flaws in the FDA’s 510(k) process — and it identifies failures in reporting and enforcement as the culprits in a large scale women’s health hazard caused by power morcellators in the United States and world-wide for two decades.” He said the report clearly identifies several key facts, including:
- The 510(k) process introduced the power morcellator to market using a predicate system that was too porous and did not consider the wide disparity between gynecological morcellators and their predicate. This is likely to be the case with a vast array of medical devices.
- FDA reviewers had an indication that a cancer may exist but considered this “low risk” and inquired no further.
- The gynecological literature contained clear indications that this oncological danger of power morcellators existed, but neither practitioners nor FDA addressed the hazard.
- The legal reporting requirements for expert practitioners is non-existent. The reporting requirements for hospitals and manufacturers is, at best, lax