Hem-o-lok clip
Three years ago, the manufacturer of a surgical clip issued a recall of a surgical device called Hem-o-lok. It is a surgical clip physician’s use on kidney donors. The recall to doctors warned the clips could dislodge in the donor’s bodies with “serious, even life-threatening consequences.”
Last October a Brooklyn surgeon used the Hem-o-lok to tie off Michael King’s renal artery when he donated a kidney to his wife. Apparently, the Brooklyn surgeon did not get the recall memo.
Twelve hours after the surgery the Hem-o-lok clip popped off. King, age 29, bled to death internally in the hospital as his wife lay nearby.
We are all accustomed to getting word of a recall of our automobiles because of some defect in the vehicle that renders it unsafe. However, have you ever received a notice of a recall of some medical device in your body? I have not and I have a bunch of stents and tubes in mine.
The problem is that there is no system for recalling medical devices in people’s bodies when a defect is discovered. There are thousands of such devices in bodies—screws and plates to artificial knees and hips.
Manufacturers do not know who the patients are that may have such a defective device. The numbers of implanted devices are increasing and so are the recalls. Nearly 2,500 such medical devices were recalled in 2008. The manufacturer would know the identity of distributors to whom they were delivered. The distributors then deliver the devices to various and sundry hospitals. They then are implanted in us humans in thousands of surgeries by thousands of surgeons in thousands of hospitals. There is no sure way to identify all those people and where they are to notify them they have a defective device in their bodies. Then there is the additional problem of which model of a device they have or even if the device has a serial number that can be tracked.
Just in 2006, surgeons implanted a million hip and knee replacements reports the American Academy of Orthopaedic Surgeons.
The health care reform legislation pending in Congress includes a proposal to set up the nation’s first comprehensive medical device registry that might help track future implants. What about all those past implants? Those pacemakers, mechanical heart valves and breast implants?
More than 1,000 recall notices were sent out in the first seven months of 2009 for such devices as tracheal tubes, catheters, pacemakers, prosthetic hips, screws, pain pumps and pieces of artificial spine. Of those more than 100 are classified as serious enough to be a “reasonable probability of adverse health consequences or death.”
Those things are in your body for life. A fellow named Richard Stone, age 49, in Florida endured months of an undiagnosed pain in his artificial hip. It was finally found that a piece of metal on the prosthetic had snapped and was scraping the inside of his femur. “I couldn’t move at all,” he said. “Even when I would move an inch, it would send a shock through my entire body.” Several batches of the hip system had been recalled eight months earlier because of similar reports of breakage, but not the one in Stone’s body.
Even if you were to receive a notice of recall of some device implanted in your body 20 years ago while you lived in Indiana, but now you live in Nevada, what do you do?
Go to a hospital and undergo another surgery to remove it? Then, replace it with what? Think your health insurance company would cover the cost or refuse on grounds it is an elective surgery or pre-existing condition?
It is all very complicated.
[Source: Las Vegas Review-Journal, Monday, October 12, 2009, page 13A]
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We could not always expect that man-made devices are almost perfect, sometimes there are lapses and shall we say mistakes, however, we should not generalize it with our doctors, we still have so many reliable doctors……..
is it normal for a screw to brake in half with in 5months???
This medical devices helps a man to extens life long. it is not expected to be perfect but most of the time effective. It is normal that there is a mistake. but its tough to have mistakes in life threathening situations.