DO NOT USE "HEM-O-LOK" CLIPS!! - Donors-To-Be

[WilliamLFreeman]

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

[sherri]

Bill,

As always thanks for keeping LDO informed. This recall is not new. It was issued in 2006. Has something else happened that you are now warning the public. The FDA issued a recall (see below)
back April 18, 2006. This was the clip used in the Michael King case at Downstate in Oct 2008 where he bled to death after donating a kidney to his wife. I would have thought after that the clip would not even be available for surgeons to use in donor nephrectomy an dwould have been discussed extensively at conferences.

How much do potential donors need to be aware of before agreeing to have this elective surgery? It seems to me that the average person does not have the extensive medical background to even know all the questions to ask. As we have seen, hospitals vary their protocols for the types of testing pre donation, surgical techniques, hospital stay, post op follow up and long term follow up.

The need for independent donor advocates with this type of knowledge is imperative. Who will protect the donors?

Thank you again.

Sherri


RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II
______________________________
PRODUCT
a) Weck Hem-o-lok ML Polymer Ligating Clips; Rx, sterile, medium large size,
non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges
per sales unit, 12 sales units per case. Catalog number 544230,
Recall # Z-1096-06;
b) Weck Hem-o-lok L Polymer Ligating Clips; Rx, sterile, large size,
    non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges
    per sales unit, 12 sales units per case. Catalog number 544240,
    Recall # Z-1097-06;
c) Weck Hem-o-lok XL Polymer Ligating Clips; Rx, sterile, extra large size,
    non-absorbable polymer ligation clips; 6 clips per cartridge, 14 cartridges
    per sales unit, 12 sales units per case. Catalog number 544250,
    Recall # Z-1098-06;
d) Weck Hem-o-lok Endo 5 Automatic Clip Applier with Medium Polymer
    Ligating Clips; Rx, sterile, single use, disposable clip applier with medium
    size, non-absorbable polymer ligation clips; 15 clips per applier, 3 appliers
    per sales unit, 6 sales units per case.  Catalog number 543965,
    Recall # Z-1099-06
CODE
All lots
RECALLING FIRM/MANUFACTURER
 Teleflex Medical, Research Triangle Park, NC, by letter dated April 18, 2006, firm initiated recall is ongoing.
REASON
The Hem-o-lok ligating clips may become dislodged following ligation of the renal artery after laparoscopic donor nephrectomy. Hem-o-lok ligating clips are now contraindicated for use in ligating the renal artery during laparascopic nephrectomies in living donor patients.
VOLUME OF PRODUCT IN COMMERCE
10,458,708 clips
DISTRIBUTION
Nationwide

[Clark]

Dear Sherri,

  The "Alert" is new, as of 5/5/11, and I put the complete text in the "News" forum.  The background explicitly identifies that the 2006 directive was made after three living donor deaths attributable to this device, and that there have been three more since, as well as advocacy for continued use in the peer reviewed literature despite the 2006 warning against this usage.  It also notes the recent OPTN/UNOS and ASTS communications to members, attempts to raise awareness among practitioners, staff, and administration.  The liability implications associated with violating this alert, which explicitly prohibits use of these clips for this purpose, suggest that insurers will also want this understood widely and well.

[WilliamLFreeman]

Sherri & Clark,

Thanks for giving the original warning, and for posting this one in the News.  As the current, more detailed, warning notes, 3 more deaths have occurred since that original recall/warning.  My guess is that the third death was recent -- if so, it probably triggered the repeat warning.  ASTS (American Society of Transplant Surgeons) had sent out a similar warning in January 2011, probably shortly after the possible third death.

You, I, and all of us would hope that Transplant Centers would take effective steps to prohibit use of Hem-o-lok clips for donor nephrectomies, that insurance companies would help enforce it, etc.  But, obviously some have not done so.  Thus the reason for this warning -- and for saying the warning was for patients, too.  LDO, NKF, and donor blogs are communication channels that can alert at least some Donors-To-Be to protect themselves.  In this case, we need to think of ourselves (i.e., we individually [especially when in contact with Centers and Donors-To-Be], LDO, NKF, donor blogs, etc.) as important parts of "the system" of living organ transplantation to increase its safety.

Bill

[Donna Luebke]

Thanks for posting on this issue. Sherri is right that this issue is not new.  Besides the death in NY, there was a death in Singapore and Israel with this clip.  Per the March 8, 2011 Advisory Committee on Organ Donation meeting minutes there was discussion about two recent donor deaths that were suspicious for a clip issue.

"Dr. Fung said that another conversation occurred recently concerning the declining rates of living donations, in light of the recent living donor liver deaths, two of which occurred in 2010. Four patients who donated kidneys died last year and there was a highly publicized kidney donor death in 2001. Yet, it’s not possible to find out the number of donors who died from the SRTR. It’s hard to get a set of numbers to present risks to patients, or for people who are considering donation to find on their own. A commentary appeared in the AJT a few months ago about how much information can be released and what would happen if it were more highly publicized. The two deaths were from the same root cause that also caused a death in 2008. People do not feel confident in the system; this also prevents people from analyzing and growing from one another’s mistakes...Dr. Barr asked if Dr. Fung’s statement referred to the hemolock clip issue and reminded the group that the ASTS issued a warning not to use the clip and the FDA also issued a warning.  This is a professional society issue, medical malpractice, and an FDA issue.  Creating awareness in the community is half the battle but not an OPTN issue"

I disagree with Dr. Barr here.  Is certainly an OPTN issue if its members are the only ones involved in this recall.  Agree with Bill here in that every layer of communication is critical to protect patients.  Perhaps if the OPTN had taken a leadership role for educational reasons--I work every day with FDA recalls and alerts due to pacemaker and implanted ICD issues.  Letters are mailed to physicians and practice groups about any issues and letters get filed in the patient's records. 

Thanks to Dr. Fung boldly speaking up at the ACOT meetings, we know of donor deaths.  In past meetings it was Dr. Conti who spoke up at the ACOTs.  Clark--are you getting this info at the OPTN or Kidney Committee level?  I have known about this clip issue since 2007. 

[stevewin@windstream.net]

What is the risk if you have this clip in your body ?

[WilliamLFreeman]

Steve,

If the surgeon uses "Hem-O-Lok" clips to close the renal artery in the donor, the clip may give way within 48 hours, thus letting the renal artery re-open up and the person bleed to death.  This has happened only rarely.  But it *has* happened at least 6 times in the USA, including at least three donor deaths since the FDA first released the warning, in 2006, not to use them to close the renal artery in the nephrectomy surgery (= "remove a kidney") in living kidney donors.  Those three deaths were entirely preventable.

There is no problem about having Hem-O-Lok clips in the body as such.  The body does not react to them in a dangerous way, and they do not poison the body in any way.  They are used to close veins, where the pressure exerted by the blood in the vein is much less than the pressure exerted by the blood in the artery.  (That is what they were designed for.)  If donors had Hem-O-Lok clips to close their renal artery it is now several days or more after surgery, they are OK -- the artery has been permanently closed by scar tissue and has no risk of re-opening.

Hem-O-Loks are small plastic clips, not metal.  They are tiny versions of the small plastic you can buy in grocery stores to close the opening of a small bag -- of chips, for instance.  I assume that the higher blood pressure within the renal artery, delivered in a pulsatile fashion (that is, our own pulse) either:  [1] caused the clips to be slowly pushed down the stump of the artery until the clips were pushed complete off; or  2] caused the plastic clip to burst open, that is, the piece that locked the clip broke.

We all hope that *NO* transplant program, and no transplant surgeon, ever uses them anywhere in the world.  But, just in case, this post is asking potential donors to ask their surgeon whether or not she/he uses Hem-O-Lok clips.

Bill

[awollangk]

If anyone needs the authoritative reference from fda.gov here it is:

http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm253237.htm

I just dropped an email to my coordinator about it.

Alex