Serious Consequences From Misuse of Medical Devices in Kidney Surgery

Kidney donor surgery is considered to be very safe, statistically. For example, more than 6,000 individuals donated kidneys in 2010, and none died within 30 days of surgery. However, a case in Texas has brought increased concern and scrutiny over the safety of kidney donors whose surgeons misuse a specific medical device known as an arterial clip. When a kidney is removed, the surgeon must sever the renal artery and then close it to prevent fatal bleeding. Though there are many ways to close the artery, some doctors use arterial clips. These clips were never intended to be used on kidney donors, though they frequently are. And in a few cases, this medical malpractice has resulted in death. A case in point occurred in 2011 when a 41-year-old woman donated a kidney to her sister. The surgery was successful, but something went horribly wrong in recovery. The donor was rushed back to the operating table where surgeons found a pool of blood in her abdomen. Floating in that pool were the clips intended to prevent the deadly bleed. The clips had slipped from the artery stumps, and the woman never recovered. Use of the clips has long drawn scrutiny from medical professionals who believe they are unsafe for kidney donors. Even the packaging for the clips has a warning symbol directing surgeons to review instructions and warnings prior to using the clips. The instructions clearly state that the arterial clips are not to be used on kidney donors. Unfortunately, the clips themselves carry no such warning. Further, the instructions are not included with the clips. Rather, the instructions come with a separate tool and are often not even kept in operating rooms for physician reference. Recognizing the danger of clips used for kidney patients, in 2006 the manufacturer of the clips sent at least three warning letters to hospitals alerting them of the potential harm to patients. Tragically, many of those letters never even reached the physicians who needed to see them. Rather, they were filed or tossed and forgotten. In situations where kidney donors suffer harm or death from the use of arterial clips, they may have the right to pursue legal action against the hospitals and medical systems that failed to properly warn surgeons of the dangers. Further, the physicians themselves may bear responsibility for improperly using a medical device for unintended purposes. The sad fact is, however, that even if a financial settlement is reached for wrongful death or medical malpractice, it will never repair or replace the damage caused by careless actions. Source: CNN Health, “Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings,” John Bonifield and Elizabeth Cohen, June 21, 2012.