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Urgent Advice: PD Clinicians in Europe, March 2011 Update |
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Domingo 20 de Marzo de 2011 00:00 |
BAXTER FLUID SUPPLY AND STERILE PERITONITIS PROBLEM IN EUROPE
ISPD GUIDANCE, March 2011
Background
Many of you will be aware of the current problem of PD fluid supplies across Europe. This is because of an intermittent contamination of endotoxin during the manufacturing process in one of the manufacturing lines at the Baxter plant in Castlebar, Ireland. This has resulted in cases of sterile peritonitis in association with affected batches of PD fluid requiring partial shut-down of the plant, a major supplier of fluids to much of Europe.
The PD fluids potentially affected are Dianeal , Nutrineal and Extraneal manufactured in Castlebar, Ireland. The risk of sterile peritonitis from existing affected fluid is considered to be very low. Patients across Europe are now also receiving supplies of PD fluids manufactured in other Baxter plants (Turkey, USA, Canada and Singapore). The temporary arrangements do vary by country in part according to the requirements laid down in agreement with the local regulatory authorities.
Clinical issues: sterile peritonitis
The principal risk is sterile peritonitis. The risk of this occurring is low as the endotoxin leak was intermittent so only a few bags in any batch have been affected.
Clinical features
- The diagnosis of sterile peritonitis should be considered in any patient with culture negative peritonitis, especially if they are using Dianeal, Nutrineal or Extraneal
- Some patients may give a history of cloudy fluid when using a specific dialysate but then draining clear fluid with subsequent exchanges
- Percentage of neutrophils in dialysate sample may be low (but not always)
Management
- Bacterial peritonitis still remains the most common cause of cloudy effluent
- All patients with suspected peritonitis should continue to be treated with the unit's standard antibiotic protocol, except when the patient gives a history of cloudy fluid only when using specific dialysate (e.g., Extraneal or Nutrineal)
- If a patient has culture-negative peritonitis and the fluid remains cloudy after 4 days of antibiotics, the fluid should be changed (i.e. stop Extraneal or Nutrineal, change Dianeal to Physioneal or to another batch number of Dianeal)
- ALL SUSPECTED STERILE PERITONITIS MUST BE REPORTED TO BAXTER who can then determine whether clusters are occurring with specific fluid batches which would then be withdrawn. Provide as much information as possible (i.e. batch numbers, fluid history)
Regulatory Issues
To read what the Europe Medicines Agency has to say about this problem please go to:
http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2011/01/WC500101074.pdf
Supplies of fluid
Baxter is temporarily supplying PD patients in Europe with supplies of Dianeal, Extraneal and Nutrineal manufactured in Baxter plants in the USA, Canada, Singapore and Turkey. The fluid supplied to your unit is determined at a national level after approval by the local regulatory authorities. Baxter has been sending information about these alternate supplies to individual PD units as they have arrived. Bags and boxes look slightly different but are matched by connection system and the PD fluids have the same characteristics as the Castlebar manufactured fluids but are not affected by the endotoxin issue. Baxter have supplied simple leaflets for patients describing how the bags are different to existing supplies. Please contact your local representative for more information and if required the appropriate leaflets to give to your patients.
Information to patients
Clinicians should determine themselves on what to tell individual patients as risk of sterile peritonitis will depend on what fluids the patient uses and overall risk of stopping a particular dialysate, e.g., Extraneal. The risk of developing bacterial peritonitis remains considerably higher than that of sterile peritonitis. Information about change in fluid supplies should be given to each patient by their PD Unit. Once replacement fluid in available the risk of sterile peritonitis related to fluid contamination will return to the usual low baseline event rate.
Simon Davies,
President ISPD
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