An Existential Threat to the Integrity and Safety of Surgical Standards of Care: “510(k) Harm”.

The Faces of “510(k) Harm”. Some of the many women harmed or killed by one example of “510(k) Harm”: The Power Morcellator in Gynecology.

Literally thousands of new medial devices are cleared for marketing every year by the United States Food and Drug Administration (FDA).

FDA clears the vast majority of these medical devices through a regulatory mechanism, known as 510(k).

It is a fact that the 510(k) clearance mechanism does NOT require any formal Level 1 data generated from a clinical trial - as is the case with prescription drugs.

All that is needed for FDA to give its blessing for a new device to enter the US marketplace are two basic parameters:

  1. The new device must be deemed to be intrinsically substantially equivalent to a pre-existing medical device already in place. But this FDA designation clearly does not guarantee that the new device’s specific application or performance environment will be substantially equivalent to the prior iteration. For example, Intuitive Surgical’s Da Vinci Robot is a 510(k) device — but every self-respecting surgeon who has ever used it would agree that before it, there was nothing even remotely like it. Yet, FDA deemed it substantially equivalent to a pre-existing device.
  2. The new device under 510(k) consideration must be classified as a so-called Class I or Class II device — That is, a low or moderate risk device, respectively. Class III or high risk devices comprise a minority of new medical devices and go through a distinct approval process where formal clinical trials are necessary. But this risk classification framework does not guarantee that all high risk devices are captured in the pre-market phase. For example, the 510(k) device known as a “Power Morcellator” was assigned a Class II designation. The very design of this dangerous device causes dissemination of the target tissues, some harboring cancer and some with malignant potential, inside the patient’s body cavity. Had the FDA reviewers been truly informed of this dangerous “design defect” or “side-effect”, the Power Morcellator would have never been classified as a moderate risk device.

The trouble is that the assignment of substantial equivalence and the risk classification implicit to the make up of 510(k) are not treated, by the FDA’s Center for Devices and Radiological Health (CDRH) with anywhere near the stringency that could achieve a “reasonable assurance of safety”, despite the intent expressed by the framers of the 510(k) legislation. How could it? The FDA 510(k) review process is simply not designed well enough at FDA to achieve such a “reasonable assurance of safety”.

In fact, both substantial equivalency to a pre-existing medical device and risk classification are assigned to any particular medical device in a somewhat subjective manner and within a relatively limited and rigid regulatory framework, by individual safety officers at CDRH — and without the benefit of a formal committee process involving multi-disciplinary review and approval. In this way, the FDA officers at CDRH really only work from information and arguments provided to them by the device manufacturers and a limited legalistic framework to assign the substantial equivalence and risk classification categories. Certainly, the main force motivating medical device manufacturers, themselves, is entrepreneurship. So relying on the manufacturer to provide an unbiased and complete perspective on a product they wish to bring to market is simply delusional. Any reasonable citizen and regulator should immediately see that such a biased and limited review process for the clearance of 510(k) medical devices poses a serious threat to the health of the American public.

Additionally, that a 510(k) medical device does what it is engineered and marketed to do is NOT a guarantee of reasonable safety or non-inferiority to existing technologies. Safety and non-inferiority are parameters that can only be scientifically assessed using properly designed Randomized Controlled Clinical Trials (RCT).

However, it is true that given the fast pace of engineering and technological development, subjecting every new medical device to an RCT is impossible and would stifle innovation — potentially to a halt.

Therefore, to ensure reasonable safety in the market space occupied by 510(k) medical devices, serious policy level thought and investment must be dedicated to improving the FDA process for assignment of substantial equivalence status and adequate risk classification — in the 510(k) space.

The best way to reform the 510(k) review process is to design a flexible but robust multidisciplinary committee review process at FDA. I believe it would behoove the FDA commissioner, Dr. Scott Gottlieb, and CDRH director, Dr. Jeff Shuren, to use, as their model, the review process used by the National Institutes of Health (NIH) to review extramural scientific grant applications in so-called “study sections” — Instead of relying on the somewhat subjective judgement of individual FDA medical officers, whose training backgrounds and time limitations will inevitably pass potentially dangerous medical devices into the US marketplace. Such multi-disciplinary review process for 510(k) devices would create highly personalized assignment of substantial equivalency and create a far more robust and scientifically cogent risk classification system.

But perhaps even more important than reassessing and revising the FDA 510(k) review process, is consideration of the appropriate orientation of surgeons and medical centers in the medical device space — because the conduct of operative practices on patients is directly influenced and changed by the new medical devices and technologies, particularly in the 510(k) space. Whether the changes triggered by new devices are truly substantial and whether they warrant high level safety data to be generated before widespread implementation, is something that physicians and medical centers are best positioned to assess with care.

The fact is that many medical devices cleared for marketing in the US through the 510(k) mechanism are able to be infused into existing and time-tested Standards of Care (SOC) too quickly and with relative ease. 510(k) medical devices bearing FDA clearance can be readily purchased and used by any doctor or hospital. Certainly from the perspective of medical device manufacturers this is a gold mine! Even more importantly, because medical devices are incorporated so easily into existing SOCs, they are amenable to legal defense if/when harm does result and is subjected to litigation— at least from a rhetorical legal perspective. In many cases, even an Institutional Review Board (IRB) approval isn’t necessary for a 510(k) device to be used in patient care — all that is needed is a doctor patient relationship and informed consent (maybe!).

Certainly, there is no shortage of professional egos, marketing desires and academic promotion needs to drive practitioners and medical centers, even high caliber academic ones, to aggressively and willy-nilly “try” new technologically advanced medical devices — on real patients. But, this collage of facts is the recipe for the ongoing disaster that has been brewing and harming unsuspecting American patients in the medical device space since the advent of 510(k) in the 1970s.

To compound the technological problem caused by 510(k), our whole healthcare system, and even some really good doctors and hospitals, seem to have entirely lost their moral compass in the revenue rich American Healthcare milieu. Market, innovate, and increase volume….These are the dominant contemporary corporate driving forces and mantras — not patient safety, proper ethics or protection of our precious and irreplaceable health insurance investments. The latter, it seems, are only marketing cliches even in fancy well-kept academic medical centers with Ivy-league affiliations.

But there is remedy to this deadly disease in the 510(k) space. First, the FDA review process for 510(k) devices ought to be fortified as described above. Certainly, physicians and medical centers ought to understand that they are legally mandated reporters of safety problems with any medical devices they use in the care of their patients. But even more critically, physicians and medical centers ought to wake up from their punch drunk and unethical slumber when it comes to “innovating” with medical devices. Hospitals are not marketing firms or places where professional egos and credentials are to be stoked and inflated into weak vanity with big bank accounts and glamorous professorships and titles. There is no excuse for any doctor or hospital to be advertising unproven and experimental procedures using fancy medical devices to potential patients — doing so is sick, deplorable and dangerous to public health.

Hospitals are places where sick people go when they are in trouble…To get out of trouble!

So, the central question every surgeon, practitioner and medical center risk manager ought to ask him/herself is whether any new 510(k) medical device they choose to use is substantially changing the conduct of any particular SOC — because if the answer is “yes”, then not only are they in “breach of Standard” (i.e., medical malpractice) when using such devices, without any real Level 1 safety data, they have no idea whether their new approach is truly non-inferior to the existing iteration of the standard. And that is simply a disastrous risk for patients — but also for medical centers, physicians and their insurers, when such “breaches” actually do harm to people and are litigated.

None of what I write here is theoretical. Examples abound!

From the “Power Morcellator” and Laparoscopic Hysterectomy for cervical cancer in Gynecology, to the “Gastric Band” in Bariatric surgery, to the metal-on-metal hip implant in Orthopedic surgery, to LASIK surgery in Opthalmology, to the more recent “novel” use of well-marketed Da Vinci Robotic equipment in a range of different surgical operations.

As I said, examples abound and there will be more! Simply too many examples of 510(k) devices substantially changing existing SOCs are attached to grave and unreasonable suffering and deaths of hundreds, if not thousands, of trusting patients in America.

Why? Is it sufficient for us to blame FDA process for creating a loophole that too easily corrupts existing SOCs in surgical practice? Of course, the FDA regulatory process in this space is abysmally inadequate and frankly dangerous. But what about physicians and hospital? Aren’t they supposed to be the last line of defense for patients — doesn’t the buck stop at the doc?

Alas, it is a verifiable fact the surgeons and medical centers involved with rapid and large scale innovation using 510(k) medical devices don’t slow down and ask the honest questions: Is this new technology substantially changing the conduct of our time-tested SOC? Do these changes warrant obtaining proper Level 1 data before we recruit massive numbers of patients to be treated using our profitable “innovation”? Are we informing our patients properly of the unknown and potential downsides of our novel approaches? Are we honest with ourselves and our patients about the fact that we really ARE “experimenting” with a new device — on human beings? Has the manufacturer done it’s due diligence to ensure that all known risks posed by its device are mitigated against as best as could be? Are we doing this to be “the first” to do something and market the next frontier in surgical entrepreneurship, or get famous in the press, or to obtain our next academic promotion? Are we doing this cautiously and deliberately to truly benefit our patients and using the well-established tools of ethical patient care, research and development with real scientific evidence and a robust academic backbone?

These are the real questions honest and introspective surgeons and medical innovators ought to be asking themselves — far away from the vanity and gloss offered them by corporate marketing and PR personnel and marketeers.

It is disturbing to know that the ease with which medical entrepreneurship/innovation is being supported by, both, FDA process and by a deviated medical ethical compass in America’s corporate medical structures, has damaged and is damaging unsuspecting lives in America. It is an almost unassailable fact that continuing along the existing dangerous path of unrestrained “innovation”, without slowing down to deliberate properly, will take both patients’ lives and our healthcare system to the brink of collapse — and destroy both, as it has many lives already.

ENOUGH IS ENOUGH!

It’s time for a return to the ethical practice of medicine, away from PR specialists and marketeers with MBAs, pseudo-MBAs and MD/MBAs in medical centers where even academics have been corrupted by the allure of easy money, technological innovation and professional fame. It’s time for physicians to recover their dignified ethical compass — thousands of years in the making. And it’s time for the FDA commissioner to get real about revamping its approach to 510(k) review of novel medical technologies — something his predecessors have all failed to do despite a clear understanding of the hazard it poses to public health.

The harm done by the corruption of existing standards of care by 510(k) cleared medical technologies is no different than that done by any infectious disease epidemic, or cancer. But “510(k) harm” is a man-made disease that, perhaps, causes more morbidity, mortality and cost to our society than any naturally occurring epidemic disease.

And just like with any other disease, it requires the eyes and willpower of astute physicians and regulators to see the root cause of the epidemic disease we shall, henceforth, know as “510(k) Harm”.

In memory of Dr. Amy Josephine Reed — Georgina of Yardley.

Hooman Noorchashm MD, PhD is a physician-scientist. He is an advocate for ethics, patient safety and women’s health. He and his 6 children live in Pennsylvania.