FDA Investigating Dialysis Machines

June 27th, 2012

People who require dialysis have it tough enough without also having to risk sudden death from faulty dialysis machines.

According to an article in The New York Times, the U.S. Food and Drug Administration (FDA) is looking into potential violations of federal regulations by Fresenius Medical Care, the nation’s largest operator of dialysis centers, which treats more than a third of the 400,000 Americans receiving dialysis.

Last November, Fresenius’s medical office sent an internal memo to doctors practicing in the company’s dialysis centers, warning them that failure to properly use one of the company’s products appeared to be contributing to a sharp increase in the risk of patients dying suddenly from cardiac arrest.

“In light of these troubling findings,” the memo said, doctors should take corrective action. “This issue needs to be addressed urgently,” the memo added later.

Great, right? Except that the memo only went to Fresinius’s own dialysis centers. The company did not warn other centers that use their dialysis machine, the GranuFlo.

“Personally, I’m troubled by the fact that Fresenius on its own initiative didn’t notify its entire customer base of this particular concern,” Steven Silverman, director of compliance for the F.D.A.’s medical devices division, said in an interview this week…. “Candidly, I just think it’s bad business and not in the interest of public health to sit on information about risks.”

The Problem

Dialysis works by clearing toxic waste from the blood, a job typically done by the kidneys. Part of the process involves adding bicarbonate–an alkaline–to neutralize toxic acid in the blood. GranuFlo dialysis machines include adding an ingredient that the body converts to bicarbonate, and it adds more of it than other machines. Because many doctors have not been accounting for this extra bicarbonate, patients have been getting an overdose.

The result:  In the Fresenius memo dated November 4, 2011, 941 patient had suffered cardiac arrest. The company’s medical staff figured out that the higher levels of bicarbonate gave patients a 6 times greater risk of cardiac arrest.

The memo only went o Fresenius clinics–not to all doctors, and not to the FDA. In fact, the FDA only learned of the problem in late March after it received an anonymous copy of the memo. In May, after its own investigation, the FDA issued an alert about GranuFlo and similar dialysis products.

So now, finally, patients can receive the treatment they need without an increased risk of sudden death. How many additional deaths occurred in the seven months between November 4, 2011, and late May 2012 that could have been prevented had Fresenius publicized its finding appropriately so that all doctors and all regulatory agencies had fair warning of the risks?


To read the full article in The New York Times, click here: Dialysis Company’s Failure to Warn of Product Risk Draws Inquiry