Baxter Urges Comprehensive Scientific Analysis of Hemodialysis Treatment Safety
· Baxter Establishes Independent Expert Panel of Nephrologists to Ensure Patient Safety · Panel to Cooperate Fully with Authorities in Comprehensive Investigation of all Aspects of the Therapy
Deerfield, Illinois, USA and Zagreb, Croatia (15 October 2001) – Following notification of 23 deaths in-volving patients in eight hemodialysis centers over the weekend in Croatia, Baxter International Inc.’s European subsidiary immediately dispatched a specialist team to work with the authorities to investigate the cause(s) of these unfortunate incidents.
"It is nearly impossible at this early point in time to identify with any certainty the causes of these patient deaths since there are many variables involved in these incidents," said Dr. Jose Divino, associ-ate medical director of Baxter’s Dialysis Business in Europe, who led the Baxter team dispatched to Croatia over the weekend when the deaths were first reported. "According to the initial reports we’ve re-ceived, we understand the autopsies showed differing causes of death and little consistency in the timing of the onset of symptoms."
The different lots and models of the Pliva-distributed P series of dialyzer (also known as the Bax-ter A series) used in 22 of 23 of these cases – one incident involved a dialyzer by another manufacturer – were not the only common elements in the treatment.
"Patient safety is our highest priority," said Dr. Divino in an interview with Croatian TV Sunday night. "That is why we feel it is critical that all aspects of the hemodialysis treatment be thoroughly inves-tigated."
No element of the dialysis treatment has undergone as extensive testing as this series of dialyz-ers. TÜV Product Service GmbH (the leading independent European authority of the safety of medical devices and specifically hemodialysis equipment) released its independent report on Tuesday, October 9, 2001, which provided irrefutable evidence supporting the safety of Baxter’s dialyzer. This confirms the four separate internal tests conducted by Baxter, following recent deaths in Spain. Baxter and TÜV con-ducted the testing according to the most rigorous and intensive standard for testing biocompatibility in medical devices, called ISO 10993. The tests took more than four weeks and included cytotoxicity, in-tracutaneous reactivity, systemic toxicity and hemolysis (dynamic and static).
All testing by Baxter, as well as independent testing by TÜV Product Service, has continued to demonstrate the safety of these dialyzers. Nevertheless, in an abundance of caution, Baxter has put a global hold on distribution of this series of dialyzers and is temporarily advising customers worldwide to temporarily discontinue use, pending the evaluation by an expert commission. Baxter will work with cus-tomers to find suitable alternative dialyzers to use in the interim.
Today, Baxter established an independent panel of recognized experts in nephrology to cooper-ate fully with all authorities in the comprehensive investigation of these dialysis incidents. The expert team will be led by Professor Bernard Canaud from Montpelier, France. The remaining members of this newly appointed commission are affiliated with several major European University Hospitals and TÜV Product Service.
Baxter International Inc. is a global medical products and services company that, through its sub-sidiaries, provides critical therapies for people with life-threatening conditions. Baxter's products and ser-vices in the areas of bioscience (including biopharmaceuticals, vaccines, biosurgery products and trans-fusion therapies), medication delivery and renal therapy are used by health-care providers and their pa-tients in more than 100 countries.
For media contacts please call:
Patricia O’Hayer, Baxter, GSM:+32. 476855462
Frank Butschbacher, Baxter, GSM: +49.172.6200822
Dubravko Miholic, Hauska&Partner, Zagreb, GSM: +385.091 315 8282