Dialysis is a process that cleanses the blood of toxic waste. Cleansing the healthcare system of unsafe medical products is not, as a recently launched FDA investigation shows, as simple.
The FDA is looking into whether the largest dialysis-center operator in the country neglected to alert customers to a serious danger associated with one of its products. The operator, Fresenius Medical Care, treats dialysis patients in its own clinics and supplies products to other dialysis centers. Last November, Fresenius warned doctors working in its clinics that improper use of one of the company’s products might increase patients’ risk of cardiac arrest. “This issue needs to be addressed urgently,” an internal memo to the doctors read.
Not as urgent, apparently, was bringing the issue to the attention of doctors working in the many other dialysis centers that used Fresenius’ products. The company did so only after the FDA received a copy of the internal memo (from an anonymous source) and confronted Fresenius. The comment to the Wall Street Journal of the chief medical officer at a dialysis-center chain that uses Fresenius products summarizes why the company is now under investigation: “If the data was sufficient to warn their doctors, then all users of the product should have been made aware of it.”
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