for Donors-To-Be, & people knowing Donors-To-Be:
(Heading of the FDA-HRSA joint warning:
"
FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy Date Issued: May 5, 2011
Audience: Urologists, Transplant Surgeons, Kidney Transplant Physicians, Hospital Administrators, Hospital Risk Managers, Clinical Transplant Coordinators, Operating Room Supervisors and Staff,
and Patients ...
Purpose: ... Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor.
Background:InApril 2006, the manufacturer ... added this contraindication to the Instructions for Use after receiving
15 medical device reports of 12 injuries and three deaths,.. between Nov. 19, 2001 and March 20, 2005 ... associated with [closing] the renal artery during laparoscopic living-donor nephrectomies.
Since ... 2006,
there have been three more kidney donor deaths, all associated with the contraindicated use.
Recommendations: ....
Patients:
If you are considering donating a kidney, talk to your health care provider about:
potential for surgical complications;
methods used during living-donor surgery, and the advantages and disadvantages of each method; and
risks and benefits associated with donating a kidney.
If you have donated a kidney and have any questions or concerns about your surgical procedure, contact your doctor."
(
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm253237.htm )
[all "
glow" was added by WLF for emphasis]
WLF's comments:
1] Donors-To-Be: I will be clearer.
Ask your surgeon if she/he uses Hem-o-lok clips -- then tell her/him that you know about this FDA-HRSA Warning and refuse the surgery if it is to be used. (Even if you feel uncomfortable talking that way to your surgeon-to-be, do it anyway. It is your life, not the surgeon's. Tell the transplant center person you deal with the same thing.) 2] LDO On-Line: if it is possible, please add this to the list of things that Donors-To-Be should do -- perhaps first on the list. This added step could be life-saving.
3] Jennifer & NKF: if it is possible, please add this to NKF's infor for Donors-To-Be -- perhaps first on your list. You added step could be life-saving.
4] Donor bloggers: Please put this warning on your blog -- preferably at the top -- for the same reason.
5] As a physician & member of my hospital's Quality Assurance Committee, I know that such notices need to spread by multiple channels of communication, not just one channel. Only redundancy can increase compliance to 100% -- a lesson the airline industry knows all too well. Although this warning says it is for patients, I do not see what the FDA & HRSA are doing to send it to Donors-To-Be. LDO, NKF, & donor-bloggers: I hope you will do that for the FDA & HRSA.
6] Although I do not know for sure, this re-sending of this warning may be related to a recent post-operative death of a living kidney donor.
7] The warning is not completely accurate. Current Living kidney donors are at no risk to have their renal artery suddenly blow open, regardless of the type of closure the surgeon used. The body forms scar tissue around and within the stump of the renal artery -- well before 2 weeks post-op. That scar is the permanent closure. Current LKDs do not need to ask their Transplant Center or surgeon anything about their own surgery. (Feel free, however, to ask your Center & surgeon if anyone uses Hem-o-loks for donor nephrectomies -- to let the Center & surgeon know that LKDs are concerned about the continued use by a few even though contraindicated!)
Bill