Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings

[Karol]

My comment: Even though warning letters went out in 2006, apparently some hospitals and surgeons are still not aware of the Hem-o-lock ban for living kidney donors. Ask before your surgery.

Kidney-donor deaths linked to surgical clips raise issues of alerts, warnings
By John Bonifield and Elizabeth Cohen, CNN
June 21, 2012 -- Updated 0222 GMT (1022 HKT)

STORY HIGHLIGHTS
Tiny surgical clips were blamed for the death of a woman who donated a kidney
Hospitals are alerted against using clips in laparascopic kidney donor surgery
But at least five deaths raise issues about whether stronger warnings are needed

(CNN) -- When Manuel Reyna developed a deadly kidney disease, his sister, Florinda Gotcher, didn't hesitate to give him one of her kidneys. When she found out they were a match, she cried.
"She was so happy," remembers Gotcher's daughter, Melinda Williams. "She was overwhelmed that she was able to save her brother's life."
Williams said her mother didn't worry about the risks of surgery. Statistically, kidney donor surgery is considered to be very safe: in 2010, the year before Gotcher's surgery, 6,276 people donated a kidney, and none of them died within 30 days of the surgery.
Her laparoscopic surgery went well, but about 30 minutes afterwards in the recovery room, she took a mysterious turn for the worse.
"She just took a deep breath and her eyes got real huge and then she fell back down and started breathing really, really bad," Williams says.
Surgeons at University Medical Center in Lubbock, Texas, rushed Gotcher back into the operating room. Once they opened her up again, they saw something horrible had happened: there was a pool of blood in her abdomen. Gotcher, 41 and the mother of four, had died from a massive and sudden bleed.
"My world just fell apart and my heart was torn to pieces," Williams says of her mother's sudden death."They told us, 'We couldn't save her. Sorry, we did everything we possibly could, but there's nothing we could do.'"
No specific warning on surgical device
Williams would later learn her mother's death wasn't a freak accident. It was actually completely preventable.
To remove a kidney for donation, surgeons have to cut the renal artery They then have to close it back up again, or the patient would bleed to death.
There are various ways to close the artery. Many surgeons use staples, but some use tiny surgical clips to hold it closed.
These clips are considered safe to use in many types of surgeries, but not laparoscopic kidney donor surgeries. In donors surgeries, surgeons leave only a tiny stump of renal artery, and the clips can slip off. That's what happened to Gotcher: when doctors opened her back up, they found the clips had slipped off the stump and were floating in a pool of blood in her abdomen.
Before Gotcher's death, four other kidney donors had died when these clips were used: one in 2001 in the United States, one each in Singapore and Israel in 2005, and another in the U.S. in 2008. At least 12 others have suffered injuries.
Starting in 2004, transplant surgeons, such as Dr. Amy Friedman, began raising concerns about using clips in kidney donors, sending letters to the U.S. Food and Drug Administration and making presentations at transplant conferences and publishing articles in medical journals.

A warning letter tells surgeons not to use a specific arterial clip on kidney donors, but many haven't seen the letter.
When she heard about Gotcher's death in 2011, Friedman said she was "devastated."
"We were just in shock and deep sorrow to learn that our actions thus far and our efforts to try to stop the practice had been ineffective," says Friedman, director of transplant services at Upstate Medical University in Syracuse, New York.
Friedman said there should be a warning label right on the clips.
"I think it would be great to say, 'Don't use on a kidney donor,'" she says.
The clip packaging does have a warning symbol advising doctors to look at the instructions that come with a separate tool used to apply the clips. The instructions, which are typically not kept in operating rooms, state the clips should not be used on kidney donors.
"It's meaningless"
Beginning in 2006, Teleflex, the manufacturer of the clips, sent warning letters alerting hospitals that the clips were "contraindicated" -- or unsafe for use -- in laparoscopic kidney donor surgeries. Hospitals received at least three letters, and some received as many as six.
Officials at University Medical Center, where Gotcher had her surgery, said they received the 2006 letters, but at the time they weren't purchasing the clip. Years later, when they did start purchasing the clips, the letter had been forgotten -- it was one of dozens of letters about various devices and other safety issues the hospital gets every year.
Friedman says the letters didn't go far enough to alert doctors not to use them on kidney donors. For example, they didn't mention that kidney donors had actually died when the clips were used on them.
"It's shocking that it doesn't say that even a single donor died. It's meaningless without saying that," Friedman says.
According to documents obtained by Dr. Friedman through the Freedom of Information Act, in 2007 the FDA called these letters "effective" and "adequate to prevent a reoccurrence of the problem" even though only about half the hospitals acknowledged getting the notification, according to a 2007 audit by the FDA.
After Gotcher's death, the FDA issued a safety notification reminding surgeons that the clips are contraindicated for kidney donor surgeries.
"It comes back to me all at once."
In a statement to CNN, the FDA said the clips, when used correctly, can effectively control bleeding. The agency added that while most transplant surgeons heeded the agency's warning, "despite repeated efforts to communicate this important safety information, some transplant surgeons continue to improperly use these clips. While the FDA can warn against the unsafe use of a medical device, doctors are not prohibited from using cleared or approved devices for an unapproved use within their practice of medicine."
Teleflex, the company that makes these clips, said surgeons have safely and successfully used them in millions of surgical procedures, and that the company believes the transplant community is "well aware" of the warning not to use them in kidney donors.
"A contraindication is a clear, well understood and accepted concept in the medical community that says, 'Do not use this device for this purpose,'" Teleflex wrote in a statement to CNN.
University Medical Center, where Gotcher died, says it wasn't using the clips when it received the warning letter in 2006, and that its system to track warnings was insufficient to alert the hospital when they later purchased clips. They've since put corrective actions in place by hiring an outside company to track and document warnings and recalls.
The hospital settled a lawsuit filed by Gotcher's family for an unspecified sum.
None of this brings back Florinda Gotcher.
"Every time I go to the cemetery it hits me," her daughter says. "It comes back to me all at once."

http://edition.cnn.com/2012/06/20/health/kidney-clips/index.html

[sherri]

This information needs to be given to be disseminated to all those involved in transplanting living kidneys. This means that surgeons, transplant nurse coordinators, living donor advocates, nephrologists, social workers, psychologists and of course patients themselves need to sign a copy of the warning letter issued by the company so that everyone is aware of this. It should be part of the pre op evaluation. Apparently, there is a miscommunication and lives are being lost unnecessarily. Medical errors are one of the main contributing factors to mortality and morbidity. Medication errors spurred changes in medication administration. Surgical errors of wrong side surgery, wrong patient, wrong procedure all gave rise to the time out concept. Surgical sites are clearly marked, time out before surgery begins to confirm patient identity, surgery type, site etc are all done to ensure PREVENTABLE errors are not made. This medical error is so preventable. All it takes is medical professionals to care about their living donors. Any hospital not abiding by this warning label should be held responsible. There is no excuse.

[kudzukimmy]

  I saw this on CNN and am wondering if and what is the alternative. I am scheduled to donate a kidney on July 27th here in Las Vegas Nv. I called Transplant Services here in my town and they said they would look into it,they hadn't yet heard of it..

[Fr Pat]

     The warning is about one particular brand of clip. Surgeons have other alternatives available. (Note for past donors: once the scar tissue has formed on the blood vessel the clip is no longer needed. We do not have to be worried now about whether or not a faulty clip was used in our surgery, as it is no longer needed. Failure would have occurred soon after the surgery. The concern now is to make sure that the "alert" has been received and acted upon so that the faulty brand of clip is not used in the future.)
   Fr. Pat

[Donna Luebke]

I first learned about this clip in 2008 after the death of Michael King.  Dr. Amy Friedman has reported and published on the hemorrhagic complications of live donor nephrectomy.  She and the FDA were repeatedly ignored.  HRSA and the FDA reissued the recall jointly following the deaths in TX. Dr. John Fung (from the Cleveland Clinic who is now serving a term on the ACOT) discussed kidney donor death within the last year or so at the ACOT meetings.  He was the only person to bring up the topic of kidney donor deaths (6) when the discussion was about the 2 live liver donor deaths in 2010. 
 
In 2006, the OPTN/UNOS Operations Committee met in Atlanta. Below is a snippet from the meeting minutes which documented knowledge of the clip recall.   What action was taken after this meeting?  During my term on the OPTN/UNOS Board, I counted at least 6-8 staffers from UNOS who were attorneys including its Ex. Director.  Not one attorney from the federal government attended the meetings.  Why not?

From OPTN Operations Committee archived minutes:
 

" e.   Laparoscopic Nephrectomy Donor Clip Recall - The Subcommittee reviewed information that was widely distributed throughout the surgery and transplantation communities related to a surgical instrument recall. It was decided that OPTN/UNOS legal counsel be consulted before any such notifications or advisories to members are distributed."
 
 I worked in a world of recalls every day (pacemakers, ICDs and leads).  We are responsible to know what is on recall and how to manage the patients.  No one spoon feeds us the info daily nor is it allowed to be lost in history.  The surgeon is accountable.  Recall notices go to managers, too.  So what about transplant administrators, those who purchase equipment, those who put together the OR trays, the Chief of Transplant and the Chief of Surgery??  There are supposed to be many layers of protections for all patients in our hospitals regardless of the recall issue.  In this case and the others--they all blew it.