Baxter Dialysis Products Face a Quality Review in EU

From Medscape Medical News
Baxter Dialysis Products Face a Quality Review in EU
Emma Hitt, PhD

September 23, 2011 — After the detection of endotoxins in certain dialysis solutions in December 2010, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has put controls in place at Baxter's manufacturing plant in Castlebar, Ireland.

"The CHMP has now finalised recommendations to ensure the continued supply of these dialysis solutions in the [European Union (EU)] while quality-improvement measures are being put in place at Castlebar to ensure the production of endotoxin-free solutions," according to a CHMP written release.

Affected products include Dianeal, Extraneal, and Nutrineal solutions for peritoneal dialysis; Monosol; and a sodium chloride solution intended for hemodialysis. The Castlebar facility as will undergo a 12-month "requalification period," and other Baxter manufacturing sites will also undergo closer monitoring.

When instances of endotoxin contamination of these products surfaced previously, the manufacturer indicated that they had detected endotoxin-producing bacteria in 2 tanks and suggested that this was the potential cause of the contamination. The CHMP notes that "undetected cracks in equipment may have allowed the growth of bacteria, while the design of the plant and the cleaning methods used may have allowed the contamination to spread." However, removal of these tanks and cleansing of other production equipment failed to eliminate the problem.

According to the CHMP, the detection of endotoxins in these solutions has resulted in the manufacture of these products being stopped in the past. However, because of a lack of sufficient alternative sources for dialysis products in the EU, it was necessary to instill quality controls and more stringent monitoring of products produced at the Castlebar facility to help ensure "continued supply of these dialysis solutions in the [EU]."

"Due to the lack of sufficient alternative sources for dialysis solutions, the CHMP could not recall all affected products from the Castlebar plant at that time," the committee writes. "However, the Committee aimed to reduce reliance on the plant and made recommendations in January 2011 for the use of products imported from four production sites outside the EU (in Canada, USA, Singapore and Turkey)."

All affected products from Castlebar were eventually recalled in stages across the EU, and the supply from Castlebar was stopped. At this time, all dialysis solutions from Baxter for the EU supply are being manufactured in sites outside the EU.

The plant is due to be inspected again in October 2011. Long-term plans are now being made to redesign the plant and to improve the cleaning and testing methods used.

According to the CHMP, healthcare professionals and patients should continue to report any symptoms indicative of aseptic peritonitis as soon as possible.

http://www.medscape.com/viewarticle/750304