The EMA is reassured about the quality of Baxter’s dialysis fluids following improvements at the company’s manufacturing facility in Castlebar, Ireland, after an investigation.
Several modifications are now being made at the site including a redesign, new cleaning methods and improved testing to ensure future endotoxin-free dialysis.
The Irish Medicines Board will also inspect the plant next month, after which it will go through a 12 month monitoring ‘requalification period’ with products undergoing rigorous testing and increased surveillance.
The CHMP began a review in December last year after endotoxins were detected in solutions which may have led to adverse reactions in some patients undergoing peritoneal dialysis.
After notifying the EMA, Baxter identified two troublesome tanks as the cause of the problem and subsequently removed them from the production line. Additional tanks and pipe works were also cleaned in an attempt to remove the bacteria.
However, endotoxins were still detected in batches of solutions produced at the plant and resulted in the manufacturing of the solutions to be stopped and shifted outside of the EU.
The affected products, including Dianeal, Extraneal and Nutrineal solutions for peritoneal dialysis; and Monosol used for haemodialysis, were eventually recalled in stages and the supply from Castlebar stopped.
Following an inspection of the plant, the CHMP concluded that the “root cause” was a combination of undetected cracks in equipment, the design of the plant and cleaning methods that may have allowed the contamination to spread.
The corrective measures being introduced at Castlebar will now be applied to Baxter’s other manufacturing plants.