Legislation is no 'cure' for what ails medical device safety

by Hooman Noorchashm MD, PhD and Amy J. Reed MD, PhD.

Published Jul. 20, 2016, 5:22 p.m. ET

The U.S. Senate is poised to pass monumental healthcare legislation, the "21st Century Cures Act" this fall.

This bill sailed through the House of Representatives with bipartisan support. It provides a serious funding boost to the National Institutes of Health for biomedical research , money critical for reinvigorating our nation's parched research institutions.

The act has the support of leading institutions at the forefront of academic medicine and research, many of which are looking at it from the perspective of their own fiscal needs and goals.

But a very serious danger to American lives lurks in the Cures Act.

Specifically, the legislation uses language framing "efficient approval of life-saving drugs and devices" to achieve expedited marketing of new biomedical products. Faster approval may be tolerable and even advisable in the drug space, because of the stringent regulatory paradigm used by regulators to evaluate drugs. But in the medical device space, expedited approval of new devices poses a clear and present danger to unsuspecting Americans.

The regulatory laxity present in the medical device space not only plagues the pre-market evaluation phase for new devices, but is also operational after new devices enter the marketplace. Neither adequate surveillance for nor "self-reporting" of dangers is taking place in the medical device space.

It is no surprise that the medical device industry advocacy groups such as AdvaMed strongly support the act – because it's good for business and it has a nice public health packaging.

Recently, the CEO of AdvaMed, Scott Whitaker, mounted a vigorous defense when the idea of delaying a Senate vote was introduced by the National Center for Health Research. This AdvaMed position shows financial advantages the Cures Act will provide the medical device industry. It is no exaggeration to state that it was carefully crafted by professional lobbyists from the industry, and by their powerful proxies in the United States Senate.

But, the recent string of safety failures is poignant and cannot be ignored. From power morcellators, to Essure, to pelvic mesh, to metal on metal hip implants, to duodenoscopes, example abound - and more are sure to emerge based on the safety deficits in the existing regulatory framework at the FDA's device section.

The immeasurable harm these failures have done make it untenable for the Senate to pass the 21^st Century Cures Act without creating effective medical device safety provisions. And certainly, the cost of these safety failures is borne not only by the American people, but also by our health insurance investments – so leaders of that industry ought to take note.

Unfortunately, the vigorous attempts made by PA congressman Mike Fitzpatrick to amend the House version of the act with the necessary safety provisions were thwarted by his colleagues. Eleven of 12 medical device safety amendments he proposed, focused on ensuring adequate reporting of safety hazards by physicians back to the FDA, were all struck down by his colleagues in the House Rules committee.

Ultimately, Fitzpatrick succeeded in rallying a bipartisan coalition, including the Rep. Slaughter (D-NY), to propose a powerful bill named the "Medical Device Guardians Act" (H.R. 5404). It requires that expert physicians confronted with significant complications and deaths resulting from the use of FDA approved medical devices to report the hazard back to FDA's public health experts.

Practicing physicians are a high fidelity source of danger signals to the FDA, yet they are not mandated to report problems. Especially in a medical devices, where safety standards are somewhat subjective, their input is necessary.

It is not too much to ask for American doctors, most of whose education and incomes are subsidized by federal tax dollars, to report problems with FDA approved devices they use as specialists.

The fate of Fitzpatrick's Medical Device Guardians Act is uncertain, as is the case with the vast majority of House bills. But the Guardians Act is the much needed safety amendment to the Senate's version of 21^st Century Cures.

Critics of the Guardians Act have stated that it is not "cost-neutral" and that the proposed device surveillance systems, using the "Unique Device Identifiers" (UDI), is superior to requiring experts to actively report problems to FDA. These are not acceptable critiques.

For starters, the reporting systems are already in place at FDA (MAUDE database and Medwatch). So, objecting to mandated use of these systems by expert physicians to inform FDA of potentially deadly hazards, on the basis of "cost", is frankly obstructionist in a setting where American lives have been demonstrably compromised and lost.

In addition, the UDI system will not only require substantial cost and time to implement, it will require active data mining to identify any hazards. But more importantly, its formal linkage to the billing records reveals the intent industry, and perhaps industry-friendly congressional personnel, have in mind.That is, more efficient and active billing of our already burdened health insurance investments.

Though the UDI system seems like a reasonable surveillance idea, the danger signals it would generate come nowhere near those of a federal reporting mandate for expert practitioners and specialists. Prominent think tanks, like the Brookings Institute, have become champions for UDI, actively or passively ignoring the fact that physicians are the best source of danger signals to FDA.

We have informed Sens. Alexander (R-TN), Casey (D-PA), Gillibrand (D-NY), Murray (D-WA), Warren (D-MA), Daines (R-MT) and their staff members of the need for a robust physician reporting system. These senators all have unsuspecting constituents who were harmed by a flawed medical device, which went unreported by expert physicians.

These senators are all well aware of the Medical Device Guardians Act (H.R. 5404), currently gathering dust in a House queue. But will they muster the courage to rise and protect American patients from deadly harm, irrespective of industry objections? Or will they remain political and equivocal?