Archive for the ‘medical device performance’ Category

Dangers of Robotic Surgery

Friday, October 11th, 2013

An unnerving study by researchers at Johns Hopkins found multiple examples of botched operations that were not reported to the FDA.  The investigators, headed by Dr. Martin A. Makary  an associated professor of surgery at Johns Hopkins , accomplished this  by combining news reports and court records, and concluded that such cases were vastly underreported. The reporting mandate that requires medical device manufacturers and hospitals to report every device-related death and serious injury to the FDA within 30 days simply is dysfuntional or worse.  It is well-known, for example, that reports made to the FDA represent only a tip of the iceberg-this includes events related to drug reactions, drug deaths, device failures, and  other significant, serious or catastrophic results of medical treatment. The “true” reporting rate for drug reactions and misadvnetures has been rated at 10%, but this is clearly a wild understatement considering that drug deaths alone, not counting suicides, exceeded auto accidents, at 40,000 a year.

Robotic-assisted surgery has taken off, 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. Between January 2000 and 2012 thousands of mishaps were reported to the FDA.  Among reports were 174 injuries and 71 deaths related to the da Vinci surgery system.

Reported in the New York Times, Sept. 10, the expansion of robotic surgery “has occurred without proper evaluation and monitoring of results,”said Dr. Makary, and senior author of the above study, who added,  “We adopt expensive new technologies, but we don’t even know what we’re getting …if it’s for good value or harmful…Because the reporting mandate has no teeth, he said, we have this haphazard smattering of reports that relies on voluntary self-reporting with no oversight, no enforcement, and no consequences.”

This is unfortunately true for other implanted devices, in particular cardiac stents and pacemakers. See my previous blog 11/6/2009. “Medical Devices: Disturbing News” (blog page 4).  As for medical devices in general and their poor oversight by the FDA because of failures of reporting, how about reducing the excise taxes on them to satisfy anti-Obamacare politicos?

 

Copyright 2013   Mathemedics, Inc.

Medical Devices: Disturbing News

Friday, November 6th, 2009

Implanted heart defibrillators cost around $25,000 each, but which patients will require or be benefited by having one remains uncertain. In 2004 Government and industry stuck a deal. Medicare agreed to expand the device’s use, nearly doubling the number of patients who qualified for one. The companies, in return, agreed to pay for a study to see which patients really benefited. But the companies reneged, backing out after putting in a measly $4 million, and the Government of the last Administration did not pick up the remaining tab. As a result, researchers still cannot gather data to determine the types of patients who would most benefit from a defibrillator, and doctors keep implanting them in patients who may not benefit at all. Many of these patients may even be harmed, especially if the device has to be removed, a dangerous procedure-something that often occurs, particularly when the batteries ultimately fail. No one even knows whether one producer’s model performs better than a competitor’s.

The problem is not limited to defibrillators or even cardiac stents. Tens of thousands of artificial hips, knees, and now shoulders are implanted every year. Doctors placing these devices have little or no reliable comparative data on which brands last longest or work best in a given patient. According to the McKinsey Global Institute, a consulting group, expenditures on implanted devices stand at about $76 billion annually in this country and are rising at a rate faster than the cost of drugs. (See this excellent article in the New York Times.)

Unlike other hospital products, implants are so-called physician preference items, meaning that doctors — not the hospitals — often choose which manufacturer’s implant to use. Profit margins on medical devices are also among the highest for any medical products, over 20% in the case of a defibrillator or an artificial hip, according to analysts.