The Titanic was a marvel of technological advancement. She was the "unsinkable" ship of her time.

But her crew and captain became complacent to safety concerns and confidently went for "speed", ignoring the icebergs ahead.

The rest is history. The "unsinkable" ship sank, definitively.

Of course, the Titanic is a true story. But it serves as an allegorical paradigm and lesson for security threats to the welfare of our own nation - a nation, which is, without question, a Titanic.

America and her institutions are, indeed, as awesome and historic as the Titanic was in her time.  

But we must learn from history and human experience. Because America cannot be allowed to sink.

We must take care and be vigilant of the proverbial icebergs in our path. Our congress, our president, our federal agencies and our fellow citizens must be on guard always – lest our Titanic be lost again.

We, and others, have identified one such iceberg in our nation's path and it will not be small in its impact.

This national security threat is fully operational and it resides in our medical device regulatory space. This "iceberg" is on a direct collision course with our nation's health insurance infrastructure and the very fabric of our society: American lives and their health.

The medical device industry in the United States is not regulated by the FDA in a risk based fashion. "Patient-safety" is not the primary goal of the FDA's Center for Devices and Radiological Health (CDRH), where thousands of medical devices used in patients are being cleared for marketing annually.

Despite this dangerous safety deficit, medical device industry advocates, many congressional representatives and even the CDRH leadership at FDA, are confidently calling for even more speed and "streamlining" of medical device approval. They are calling for tax advantages to further stimulate this dysregulated industry.

Senator Lamar Alexander, Senator Bob Casey, Senator Elizabeth Warren, Senator Jeanne Shaheen, Senator Pat Toomey, Congressman Mike Fitzpatrick, honorable members of the United States congress, we ask you: Why?


Their rationale is that increasing the speed of marketing will deliver presumably "life-saving" devices to market faster. That the economy will boom and that innovation will be spurred because of this increased speed.

Indeed, the Titanic crashed into its fateful iceberg confidently and with great speed and efficiency.

Let us be clear, we grant that only a minority of medical devices in the repertoire of existing devices are dangerous and unrecognized. But each one of these minority subset of faulty devices triggers an enormous human and dollar cost to our society when it avoidably harms patients.

So, when the minority subset of dangerous devices present in the healthcare milieu do harm, the human and dollar cost to our nation is exponentially compounded.

Now imagine, further increasing the speed with which such devices get into the market-place without any real safety measures – and you have an iceberg on a direct collision course with one of the most robust and vigorous healthcare systems in the history of human civilization.

In October of 2013, a FDA cleared power morcellator upstaged an early stage cancer in our family. This device was a dangerous one that had made it into the marketplace unchecked. The human, psychological and spiritual cost of this complication to our entire family is immeasurable. And, as of March 2015, the dollar cost of care to our family and our health insurance infrastructure stands at near $400,000 – not to mention the hidden costs of dealing with illness.

We invite the reader to extrapolate the numbers. They are enormous.

And ours is only one of the families affected by a single faulty device. There are many more - hidden from view at home, in long-term acute care facilities, and dead.

Hidden from our society's consciousness because they are harmed by devices bearing a seal of FDA clearance used in "standards of care" by licensed physicians - this is why it is an enormous iceberg, a National Security Threat, camouflaged by our irrational confidence and exuberance about our own healthcare system and its associated industries and federal agencies.

The "unsinkable" ship sank because her captains became complacent, arrogant, and comfortable in the luxurious glow of their ship. They failed to recognize their primary mission, which was to safely get the passengers and cargo to the other side of a perilous terrain.

In March of 2015, we are reiterating to you, the reader, a severe national security threat is looming in our own medical device regulatory space. It promises to devastate more families and blow an even bigger hole in our health insurance infrastructure. And our time is running out to reverse course.

Let's hope that this time those on board the American Titanic awaken her captains from their ignorant slumber, to the looming hazard ahead.

This iceberg is not small. And we are all on the ship.

Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed's unsuspected uterine cancer was spread by the device during a routine hysterectomy.


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