As evidence of the danger posed by cancer-spreading power morcellation mounted, there was intense debate within the medical device and healthcare communities. The solutions proposed were narrow in nature, such as the use of surgical bags during morcellation. But America's Health Insurance Plans says the safety scare points to the need for broader regulatory reform in a letter to Sen. Robert Casey (D-PA) noting that "the serious gaps in the current approval and post monitoring process for medical devices."
"The experience with power morcellators also shines a spotlight on gaps in the device safety infrastructure and the critical need to strengthen the pre- and post-market review and approval process," wrote America's Health Insurance Plans (AHIP) CEO Karen Ignagni in the letter.
In particular AHIP recommends strengthening the 510(k) process used to gain FDA clearance. The pathway is used to approve almost all new devices under the argument that the product being reviewed is "substantially equivalent" to a prior predicate device. In contrast to the more stringent PMA pathway for novel or high-risk devices, clinical trials are not required.
The doctrine of substantial equivalence has been used to approve such seemingly novel (and it turns out, dangerous) devices as power morcellators and metal-on-metal hips. In both cases, the manufacturer cited multiple substantially equivalent devices to gain initial clearance, paving the forward for other similar devices to use the pathway too.
The FDA first cleared a power morcellation device in 1991. Manufacturer Cook Medical cited four substantially equivalent devices. In the case of metal-on-metal hips, 6 predicate devices were cited, one for each unique feature of the new implant. None of the 6 devices had all of the new features found in Johnson & Johnson's ($JNJ) DePuy ASR XL Acetabular Cup System. In turn, other metal-on-metal hips hit the market, citing the ASR as the substantially equivalent predicate device.
In a guidance document issued last year, the FDA said it will frown upon the use multiple of predicates device in 510(k) submissions, or what's known as "split predicates."
The Institute of Medicine recommended scrapping the 510(k) in a 2011 report.
AdvaMed defended the clearance pathway. "FDA's 510(k) review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical advancements," said the trade association's CEO, Steve Ubl, in a statement, according to The Wall Street Journal.
The other major focus of the letter was the need to improve medical device's postmarket surveillance system.
"Requiring post-marketing review will greatly improve our ability to identify adverse events and to act more rapidly when safety issues are identified. Had this been required for morcellators, safety issues would have been identified much sooner," AHIP said.
AHIP said it supports federal implementation of unique device identification to enable tracking of individual devices. "UDI integration into clinical data sources, like device-specific registries and EHRs, is a key part of the FDA's vision for a national medical device surveillance system--a vision that a number of our member health plans actively participated in developing. Expanding UDI use would also complement the FDA's Safety Sentinel project in which our member plans have been integrally involved," the letter said.
The federal agency that administers Medicare and Medicaid (CMS) has not been as supportive of UDI. Former CMS administrator Marilyn Tavenner told Congress in a letter that logistics and cost concerns make implementing UDI into federal insurance claims forms difficult.
Still, at the behest of the FDA, the Brookings Institution recently proposed a multiyear, $250 million plan to implement a public-private postmarket surveillance system for medical devices. The FDA's current rudimentary postmarket surveillance is widely believed to be insufficient.
In addition, AHIP said it has reached out to the American College of Obstetricians and Gynecologists "to encourage that greater clarity be provided for clinicians regarding the use of these devices." The letter says the medical association has "has affirmed that, while power morcellation may still be appropriate for some women, the FDA's new contraindications and recommendations for providers and patients will help protect women from potentially harmful outcomes."
- here's the letter
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