Volume 11  Number 2  April 23, 2014
Second Opinions

Robotic Surgery and Device Registries

I don't make jokes I just watch the government and report the facts.

Will Rogers

You can straighten a worm, but the crook is always in him and only waiting.

Mark Twain

A Google search term, "popularity of robotic surgery" yields 61 million hits. Clearly, the American public has been profoundly influenced by the new technology, despite the cacophony of pros and cons in news articles and the medical literature. This is a typical example of our enthusiasm for anything new, especially in the fields of medical "advances," including nutrition and diet, etc. The British and most Europeans often act more conservatively, trusting the "old," before leaping in. They are constantly surprised at an incautious American habit of trying out anything that appears novel.

At present, patients are besieging medical insurers with requests for robotic surgery, knowing little about it or the surgeons performing it. Blue Cross and most insurers, to my knowledge, do not allow additional allowances for robotic surgery, but you can bet that hospitals having spent multimillion dollars to install these systems, will fold in these costs-and more-in ancillary services and negotiated per diem charges.

Unknown Dangers of Robotic Surgery

Newer, more complicated Medical devices include those devoted to Robotic-assisted surgery. These systems have taken off, sales increasing more than 400% in the U.S. between 2007-2011. A leading company, Intuitive Surgical Inc. the manufacturer of da Vinci Systems sold over 1,400 such systems costing between $1.5million-$2.5 million to scores of hospitals according to Intuitive's Investor Reports. The outlook for the Robotic Surgery Equipment Manufacturing industry is highly optimistic, with revenue projected to increase at an average annual rate of 15% to $4.2 billion in the five years to 2016.

I have previously written about an unnerving study from Johns Hopkins published online in the Journal for Healthcare Quality last year. The Hopkins team says that of the one million or so robotic surgeries performed since 2000, only 245 complications — including 71 deaths — were reported to the U.S. Food and Drug Administration. That's a combined complication/death rate of only 0.00024%! What if the reporting rate were closer to 1% — the FDA's own estimate of the true number of all serious adverse events resulting from prescription drugs? See my recent blog.

When an adverse event or device malfunction occurs, hospitals are required to report these incidents to the manufacturer, who in turn is required to report them to the FDA. But this rarely happens. The investigators, headed by Dr. Martin A. Makary, combined news reports and court records, and found multiple examples of botched operations that were not reported to the FDA. A previous study found that 57% of surgeons using the robotic system reported such serious operative malfunction they had to convert immediately to laparoscopic or open surgery as a result.

The expansion of robotic surgery "has occurred without proper evaluation and monitoring of results," said Dr. Makary, who added, "...Because the reporting mandate has no teeth we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement, and no consequences." (my italics)

As part of their study, the researchers found several incidents reported in the national news media that were not reported to the FDA until after the stories appeared in the press. This is unfortunately true for other implanted devices, in particular cardiac stents and pacemakers. See my previous blog.

When Will a National Medical Device Registry (NMDR ) be Enacted?

The Patient Protection and Affordable Care Act of 2010, "Obamacare," has been cruelly and unjustifiably attacked for largely partisan political reasons. Yet few appreciate the dramatic changes it originally contained, including, but not limited to a national medical device registry. This was planned to be established by the Department of Health and Human Services (HHS). Within the registry, devices would have been listed by type, model and serial number, or some other unique identifier.

"The registry was intended to assist HHS in evaluating the safety and effectiveness of all implantable medical devices, including all orthopaedic implants, defibrillators, pacemakers, etc. It would link data provided by manufacturers to the U.S. Food and Drug Administration with outcomes data drawn from many sources, including Medicare claims data and electronic medical records. The registry data and analyses would be stripped of patient information and ultimately made available to the public and the Centers for Medicare & Medicaid Services (CMS)." (Source)

But the registry was finally excised and not included in the final version of the bill

If this registry is not ultimately established researchers will continue to be denied funding to gather critical data on the types of patients who would most benefit from a defibrillators, joint replacements, robotic surgery systems and other devices. "Without follow-up on outcomes, medical opinion will remain divided. We still won't know how products compare with each other how many people really need a specific device, and which patients will be harmed," said Dr. Makary. But there is some hope. To help fund healthcare reform, HR 3590 increases the tax on most medical devices. Since Jan. 1, 2013, all device manufacturers are required to pay a 2.3 percent excise tax on medical device sales. This tax is expected to lead to the collection of $20 billion over a decade.

Big Bucks: The Medical Device Industry

The medical device industry maintains one of the highest profit margins in the private sector, over 20% of sales. From 2003 through 2009, Medicare paid more than $100 billion for 6.9 million procedures related to medical devices. According to the consulting firm McKinsey & Company, the United States spends about 50 percent more than expected on the top five medical devices, compared with Europe and Japan. McKinsey calculates that this amounts to $26 billion in excessive spending each year.

The so-called mandate that requires medical device manufacturers and hospitals to report every device-related death and serious injury to the FDA within 30 days is simply unenforced and is dysfunctional or worse. After all, it would require more Government spending.

Martin F. Sturman, MD, FACP

Copyright 2014, Mathemedics, Inc.

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