Over the past year a number of egregious safety failures at the FDA's medical device section have highlighted a dangerous threat to unsuspecting patients across our nation.
Federal reports and discussions on the floor of congress are great. But a practical solution needs to be proposed and implemented quickly – because there are sure to be other devices, as yet unidentified, harming patients across our nation and costing our insurance investments untold billions.
So far the only solution that has gained traction in either house of congress is to add barcodes, known as Unique Device Identifiers (UDI) to all medical devices – this, in hopes of being able to identify trends in adverse outcomes.
But the "surveillance" method proposed by the UDI advocates is not a practical solution for many reasons. Most important among them: simply having the ability to do surveillance, assuming the system comes online anytime in the future, does not necessarily lead to adequate "active" surveillance. And to do such active surveillance would be a costly government endeavor.
There is a far simpler solution that must be recognized by all patients, patient advocates and federal lawmakers – and the medical device industry itself. Our proposed solution is the introduction of a "Medical Device Guardian Act" by congress. This act would be focused on three parameters that will ensure efficient identification of deadly risks to patients' lives.
The first component of this proposed Guardian Act would be focused on eliminating conflicts of interest at FDA. Elimination of "experts" and FDA leaders with direct, or indirect, financial conflicts-of-interest from the FDA review process is critical. In other words, if a physician's practice and livelihood depends on a certain medical device, that physician cannot be objective. A clear example of this type of conflict was apparent on the FDA panel on morcellation and in the minimally invasive gynecological community's defense of morcellation.
The second component of the Guardian Act would be focused on efficient "self-reporting" of adverse events to manufacturers and to the FDA. When a device is used and causes an adverse outcome in a patient, the doctor and the hospital, almost always, have this information. It is the fear of liability and the FDA's lax enforcement of "self-reporting" requirements that has created a "culture of complacency" in the medical device space. Most doctors, hospitals and manufacturers do not behave responsibly because FDA enforcement is poor. This is not the so much the case in the drug space – which indicates that boosting federal "self-reporting" mandates for medical devices could be a very practical and efficient means of achieving safety. Legislation that would protect individual practitioners from liability when reporting adverse outcomes associated with the use of medical devices, and prosecuting failures to "self-report", would reveal problems very quickly.
The final component of the Guardian Act would be to ensure adequate market signals to manufacturers through the court system. The right of harmed patients to seek justice must be robustly defended in the medical device space through legislation. Currently, many medical device manufacturers are protected from any liability – the most disturbing example of this is Bayer Health's Essure female sterilization device.
The industry friendly "surveillance" paradigm involving the use of UDI's, being proposed by congressional Democrats and several left-leaning think tanks is okay – but it does not go anywhere near solving the problem. Fear of prosecution and liability are powerful tactics to bring safety to the medical device space.
The Medical Device Guardian Act is consistent with Republican principles and politics. In a Republican-led Congress that criticizes Democrats for failing to protect citizens' lives and to serve free-market principles, let us see if Congress finds itself capable of a Guardian Act.