Davita paid study says Okay to Use Recycled Dialyzers, really.

[greg10]

What the press release doesn't tell you is that the study was published as an abstract by a researcher, T. Christopher Bond, working for Davita.  In the past these types of studies also include incidences of pyrogenic reaction to dialyzer reuse which was not studied in this abstract.
NKF: Okay to Use Recycled Dialyzers

Source reference:
Bond T, et al "Dialyzer reuse with peracetic acid does not impact patient mortality" NKF 2011; Abstract 224.
By Ed Susman, Contributing Writer, MedPage Today
Published: May 02, 2011
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and
Dorothy Caputo, MA, RN, BC-ADM, CDE, Nurse Planner   
Action Points 
Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed journal.

Explain that using reprocessed dialyzer membranes did not appear to place dialysis patients at any greater mortality risk compared with single use dialyzers.

Note that reprocessed dialyzers were sterilized with peracetic acid.
LAS VEGAS -- Using reprocessed dialyzer membranes did not appear to put dialysis patients at any greater mortality risk, researchers said at the National Kidney Foundation Spring Clinical Meetings.

For this retrospective modeling study, patients were followed for one year at centers where reprocessed dialyzers, sterilized with peracetic acid, were used almost exclusively, and then compared with patients at centers that only employed single-use dialyzers.

The authors used propensity scoring to analyze the data. Propensity scoring is a statistical method that uses observational data to create an artificial clinical trial scenario, explained Mahesh Krishnan, MD, MBA, MPH, vice chairman of clinical research at DaVita Clinical Research in Minneapolis.

Based on a propensity-score matched analysis of likelihood of death by reprocessed dialyzers versus single use after one year, the authors reported 1,789 deaths among 17,801 patients using reprocessed dialyzers and 1,785 deaths among 13,801 patients using single-use dialyzers.

"There was no significant difference in the outcomes between these two groups," Krishnan told MedPage Today.

He and his colleagues also noted that deaths per 100 patient-years came out in favor of reuse – 15.2 deaths per 100 patient-years in the group that used reprocessed diaylzers and 15.5 deaths per 100 patient-years in the group that used single-use dialyzers.

Previous research has indicated that dialyzer reuse can reduce costs and medical waste without negatively impacting patient outcomes. But other reports have suggested that recycled dialyzers put patients at a higher mortality risk.

Krishnan said his group undertook this study to address the issue of recycled dialyzers and mortality risk, reviewing reuse patterns at 484 large dialysis centers nationwide.

He acknowledged that a limitation of the study was its retrospective nature. However, the authors were able to control for confounding factors with this modeling study, he said.

"Center-level and patient-level analyses showed no association between dialyzer reuse and mortality over the course of one year," Krishnan said. "These data support the larger historical body of literature in which studies that adequately address confounding show reuse had no adverse effect on clinical outcomes."

He also pointed out that using single-use dialyzers are not inherently safer: The chemicals that are used to create single-use dialyzers can cause an allergic reaction in some patients. Recycled dialyzers sterilized with peracetic acid do not carry the same risk for allergic reaction, Krishnan said.

"There are actually clinical benefits to reusing these membranes," commented Lynda Szczech, MD, associate professor of medicine at the Duke University and president of the National Kidney Foundation.

The concept of recycled dialyzers was the source of some controversy when formaldehyde was used to clean the membranes, she told MedPage Today. While formaldehyde was an effective sterilizing agent and did not cause clinical problems, the use of "embalming fluid" was a public relations problem.

The results of this study using recycled dialyzers cleaned with peracetic acid should make this cost-saving option more appealing to dialysis centers. "Peracetic acid does not have the stigma associated with formaldehyde," she said.

Krishnan had no disclosures.

Szczech disclosed financial relationships with GlaxoSmithKline, Gilead, Roche, Affymax, Kureha, AstraZeneca, Merck, FMC-MA, and AMAG.

Primary source: National Kidney Foundation
Source reference:
Bond T, et al "Dialyzer reuse with peracetic acid does not impact patient mortality" NKF 2011; Abstract 224.

[noahvale]

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[jbeany]

It will stay more "cost effective" until their actuary informs them that the possible losses from lawsuits is greater than the cost savings.  Unfortunately, the losses are consistently low, even for fatalities, because when they cause a death, it's most frequently of someone older and in ill health, with little prospects for a high number when a lifetime of lost wages are calculated and the jury adds up and awards the damages.