September 08, 2014
1 min read
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NRAA asks FDA to consider allowing import of PD solutions, warns of hardships if shortage continues

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The National Renal Administrators Association has asked the U.S. Food and Drug Administration to consider allowing peritoneal dialysis solutions to be imported from other countries to address Baxter Healthcare's shortage of the sterile solutions in the United States. In a letter to the agency, the NRAA expressed concern about the impact of the shortage on small and medium sized dialysis organizations and their patients.

"As you may know, PD is the most common dialysis therapy for patients who choose to receive their dialysis treatment at their home. The Centers for Medicare & Medicaid requires that dialysis providers educate patients on all dialysis modalities and provide the modality that each patient selects. NRAA Members have informed us that the interruption in the supply of these products has resulted in the facility no longer being able to offer home dialysis as a viable treatment option due to the limitations set by Baxter on accepting new PD patient orders."


Related Baxter, FMC sign supply agreement; ISPD 'deeply concerned' about PD fluid shortage


The NRAA also said they are concerned that many patients might have to switch from home PD to in-center hemodialysis if the supply continues to be interrupted, which could cause "significant hardships" for dialysis providers and patients. "Some patients have significant transportation problems that are mitigated by being on home dialysis and they have now lost this option. Providers may have to recruit and train more staff to accommodate unexpected growth in their in-center HD population."