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Donating a kidney to save the life of a friend or family member is perhaps one of the noblest things a person can do. While the surgery is by no means minor, it does enjoy a high success rate and seems relatively safe. In fact, statistics show that in 2010 alone, some 6,276 people donated a kidney and not one of them died within 30 days of the procedure.
However, would your attitude toward kidney donation change if you knew that a small percentage of physicians were still using medical equipment that had been linked to multiple deaths and serious bodily injury over the years?
According to reports, some physicians performing kidney donations/transplants are using a type of surgical clip that is not suitable for the procedure.
In a kidney donation procedure, the physician must cut the renal artery and close it once the procedure is complete to ensure that the donor does not bleed to death. Physicians employ a variety of methods to accomplish this task, including staples or small surgical clips.
The problem with the clips, however, is that while they are acceptable for many other types of surgeries, they are sometimes unable to stay firmly attached to the very small stump of renal artery remaining after the surgery. In fact, if the clip comes undone, it can cause blood to pool in a patient’s abdomen, a potentially fatal condition.
Sadly, five people have died and another 12 have been injured as a result of surgical clips coming undone after kidney donation surgery.
The manufacturer of the clip has printed a warning on the packing of the clips indicating that physicians should read the instructions that come with a separate tool before use. Here, the problem is that the instruction manual outlining the kidney donation dangers is typically not available in operating rooms.
In addition, the manufacturer also mailed letters to hospitals around the country warning them that the clips were unsafe for use in kidney donation procedures back in 2006. However, the letters didn’t actually indicate that anyone had actually died from the clips. Consequently, many of them were filed away and essentially dismissed by many hospitals.
It is worth noting that the FDA has come out in support of the clips, calling the manufacturer’s letter campaign “effective” — despite the fact that a 2007 audit revealed that only half of the hospitals surveyed indicated that they received a letter.
However, the agency did send out a safety notification following the recent demise of a Texas woman.
It remains to be seen how the medical community will respond to this hidden yet very real medical malpractice threat.
Source: CNN, “Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings,” John Bonifield and Elizabeth Cohen, June 21, 2012
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