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Dialysis Discussion => Dialysis: News Articles => Topic started by: okarol on July 31, 2010, 07:34:57 PM
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Equipment mix-up dredges up age-old issue in dialysis treatment
BARBARA COTTER
2010-07-30 18:15:31
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For three years, 62-year-old Preston Price has been undergoing dialysis to do what his failing kidneys can’t: filter out impurities in his blood. It’s a process that eats up four hours of his day, three days a week, but typically it’s so uneventful that he tends to doze through it.
In April, however, Price’s routine at Pikes Peak Dialysis Center went awry when he was mistakenly hooked up to a reusable filter, a dialyzer, that belonged to another patient — a person who had a virulent bacterial infection commonly known as MRSA. Price’s health was probably not in danger, his doctors say, and giving one person’s dialyzer to another patient is a mistake that doesn’t happen often at Colorado dialysis centers.
But it happened to Price, and it happened in February at a sister clinic when a patient was given a dialyzer belonging to someone infected with Hepatitis C.
For Pikes Peak Dialysis Center and Printers Place Dialysis Center, both owned by Denver-based DaVita, the mix-ups resulted in an investigation by the Colorado Department of Public Health and Environment.
Investigators cited the centers for failing to notify the department about the incidents and not immediately revising their policies. They also found a number of deficiencies in the centers’ operations, and ordered them to come up with corrective actions to prevent such mix-ups and address unrelated issues, most of them centering around record-keeping.
For dialysis patients, the cases go to the heart of an issue that has long been debated in the medical field but might not be on their radar: Should they opt to be treated with a reusable dialyzer — one that is supposed to be used on that patient only and sterilized after each use? Or is it better to go with single-use dialyzers, which are used once, then tossed?
The human factor
Beginning in the early 1980s, re-use became the status quo. Reusable dialyzers were cheaper, and they didn’t produce the anaphylactic-like “first-use” symptoms associated with single-use dialyzers. In 2000, according to the U.S. Center for Disease Control and Prevention, 80 percent of dialysis centers opted for reusable dialyzers.
But a new generation of single-use dialyzers that were cheaper and less likely to produce first-use issues came on the market. According to a 2007 study by researchers from Tufts University Medical School and Boston’s St. Elizabeth’s Medical Center, the percentage of centers going the re-use route had dropped to 40 percent by 2005.
Still, dialysis experts say re-use is safe — if done correctly and according to quality control standards. That’s a big “if,” however, because re-use relies on a series of human protocols to get everything right, and that boosts the chances for mistakes, the researchers concluded.
“Full compliance in a practical setting ... is difficult to attain, and rigorous quality control standards are vulnerable to poor implementation,” wrote the authors, who declined to be interviewed.
Dr. Michael Lazarus, who taught nephrology at Harvard University and ran the dialysis program at a Boston hospital, put it more succinctly: “When you have humans doing things, they make mistakes.”
Lazarus used to be in the re-use camp, but changed his opinion after he went to work as chief medical officer for a division of Fresenius, a global health company and a major player in the dialysis business. He knows some people will say he became a single-use devotee because Fresenius manufactures the devices, but he said it wouldn’t matter where he worked. Single-use is safer, he contends.
“You remove that potential for human error; it’s gone,” he said.
Mix-ups with reusable dialyzers don’t occur often, though. An official with the Colorado health department said the Colorado Springs cases are the first she’s encountered in seven years at the agency, and Dr. Stephen Fox of Pikes Peak Nephrology Associates said he had seen only one in his 22 years of practice.
“So to have two incidents in a short span of time is very unusual and very troubling,” said Fox.
Lazarus said that getting the wrong dialyzer rarely puts the patient at risk. Sterilization of dialyzers after each use kills most pathogens, including MRSA, he said, so Preston Price is likely in the clear.
“In 99 percent of the cases, it doesn’t matter. It’s like wearing someone else’s underwear; it’s not pleasant, but it doesn’t hurt anyone,” said Lazarus. “There’s a big psychological issue: ‘My blood is going through this artificial kidney that someone else has used.’”
More troubling is the patient who was exposed to Hepatitis C, because neither that virus nor AIDS can be killed with current sterilization techniques, he said.
And there’s no guarantee that the cleaning and sterilization process will go according to plan. In 2007, a 71-year-old Muskegon, Mich., woman being treated at a DaVita center died after being hooked to a dialyzer that wasn’t properly rinsed after cleaning. The corrosive cleaning agent got into her bloodstream and killed her.
“You can set up all kinds of systems — ‘we’ll do this and we’ll do that’ — but sooner or later, if you don’t have an absolutely perfect system, you’ll make mistakes,” Lazarus said.
Defending re-use
In the two Springs cases and the one in Michigan, dialysis technicians were blamed for the mistakes, lending ammunition to the argument by Lazarus and the researchers who conducted the 2007 study that re-usable dialyzers leave the door open to potentially serious human error.
In fact, the researchers strongly come down on the side of single-use dialyzers, concluding that “there is no compelling medical indication for reprocessing dialyzers in the new millennium” and the only reason providers like reusable dialyzers is because it saves them money.
Joe Atkins, CEO of a dialysis consulting business in Ohio, acknowledges the money-saving aspect, but writes in a March story in Renal Business Today that reusable dialyzers produce better results for patients because single-use versions are less efficient.
DaVita, second only to Fresenius as the biggest dialysis provider in the U.S., cites a recent article in Nephrology News & Issues showing that seven of the top 10 dialysis operations still offer reusable versions — though DaVita is the only one in El Paso County to do so.
“The reuse of dialyzers is a safe, widely utilized practice throughout the industry,” DaVita spokesman Vince Hancock said in an e-mailed statement.
“The federal government, which oversees dialysis safety, approves reuse of dialyzers through the Association for the Advancement of Medical Instrumentation’s stringent standards which we have always been fully compliant with,” Hancock added. “Also, the National Kidney Foundation has published literature validating that reuse is a safe and commonly accepted practice in kidney care.”
Hancock said there’s independent research showing dialyzer reuse reduces patient exposure to chemicals.
“While each single-use dialyzer is rinsed with saline prior to use with a patient, there can be residual sterilent that can contribute to a patient reaction. But Dr. Jesse Flaxenburg of Pikes Peak Nephrology Associates said new generations of single-use dialyzers are sterilized in other ways, and chemicals are no longer used.
“In other words, advancing technology has made the ‘chemical exposure’ argument a non-starter,” he said.
Flaxenburg and the other doctors at Pikes Peak Nephrology were so alarmed by the back-to-back incidents at the Springs clinics that they sent a letter to their patients in May to say they could “no longer support dialyzer reuse,” and to educate patients on how to protect themselves if they decided to continue with reusable dialyzers. Flaxenburg also said the doctors at the practice, which is being sued by DaVita over an unrelated issue that involves support for a competitor, have started educating patients about the two types of dialyzers since the cases came to light.
“It never really popped into our frame of reference until this,” said Flaxenburg. “It’s a standard educational piece now.”
Hancock says it’s also DaVita’s practice to educate patients about their dialyzers options and give them a choice which to use. Patients then sign a consent form. But Preston Price says he was never given the option, and a few former DaVita patients told doctors they signed a lot of papers when they started dialysis, but don’t recall being informed about their choices.
At this point, the clinics are working with the state on their plans of correction to ensure.
“Patient care is our number one priority, but mistakes can and sometimes do occur,” Hancock said in his statement. “We have rigorous processes and controls in place to minimize errors such as this, but when they do happen we respond aggressively, even when no patient harm occurs. We have also re-emphasized our policies and procedures with our employees to further reduce the likelihood that this could occur again.”
But Preston Price isn’t hanging around to find out. He switched to a competing dialysis provider that does not offer reusable dialyzers, and said the center where he was receiving treatment dropped the ball.
“If you’re a professional, you’re supposed to know what you’re doing,” Price said. “Three people are supposed to check that dialyzer before it goes into my body, but something happened that day, because they let it slip through their hands.”
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Learn more about the issue:
"Single-Use versus Reusable Dialyzers: The Known Unknowns" -- 2007 report by researchers from Tufts University medical school and St. Elizabeth's Medical Center in Boston: http://cjasn.asnjournals.org/cgi/content/full/2/5/1079
Write-up on the benefits of re-use, in Renal Business Today: http://www.renalbusiness.com/articles/2010/03/dialyzer-reprocessing-and-the-bundle.aspx
"Why Fresenius Medical Care Decided Not to Reuse Dialyzers," by J. Michael Lazarus: http://www.aakp.org/aakp-library/Fresenius-Reuse-Dialyzers
"What You Should Know About Dialyzer Reuse," the National Kidney Foundation: http://www.kidney.org/atoz/pdf/dialyzer_reuse.pdf
http://www.gazette.com/articles/dialysis-102303-old-years.html