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Croatian Health Minister resigns after dialysis deaths
SCIENCE AND MEDICINE
NEWS Croatian Health Minister resigns after dialysis deaths
THE LANCET • Vol 358 • October 27, 2001
Medicine, the Croatian Institute of Public Health, and the Ministry of Interior. He also said that the committee contacted the US Food and Drug Administration after the death of two haemodialysis patients in Austin, Texas, on Oct 16.
Rights were not granted to include this image in electronic media. Please refer to the printed journal. AP
he Croatian Prime Minister, Ivica Racan, accepted the resignation of his Health Minister on Oct 23 in the wake of the deaths of 23 patients who died during or shortly after receiving haemodialysis between Oct 8–13. The Prime Minister said that an internal interim report from the health ministry showed that poor communication between the Ministry and Croatia’s health institutions led to an increase in the number of deaths. “How much of it rests with the manufacturer of dialysers and possibly how much on the distributor will be shown after the investigation”, added the Prime Minister. The government will also help families with compensation claims, he said. On Oct 13 the Health Minister, Ana Stavljenic-Rukavina, launched an investigation into the deaths of 23 patients who died in six medical centres in Croatia. The usual death rate among Croatia’s 2600 dialysis patients, who are mostly more than 60-years-old, is 5–7 per week. The former Minister told The Lancet that after examining the patient data the only common factor was the dialysis membrane—the A-15 and A-18 brands manufactured by the US company Baxter International. The Health Minister immediately ordered Croatia’s 44 dialysis centres to stop using the filters but this came too late for six patients in Pula, who died using the same dialysers on Oct 14. The dialysis-related deaths in Croatia happened 2 months after 12 similar deaths in Spain where Baxter A-18 dialysers were also implicated. Stavljenic-Rukavina also formed an investigative committee of nephrologists, forensic specialists, toxicologists, epidemiologists, and patient representatives, to take a closer look at the recent deaths. Vladimir Gasparovic, head of the haemodialysis centre at the Zagreb University Hospital Centre and member of the Ministry’s committee, told The Lancet that the necropsies of some of the patients were done and that the committee is now waiting for the results of toxicology tests done at several independent institutions including the Zagreb School of
T
Ana Stavljenic-Rukavina
On Oct 14 Baxter dispatched a specialist team to Croatia to work with the authorities to investigate the incident. At the press conference in Zagreb the following day, Jose Divino, Baxter Associate Medical Director for Europe, said that there were differences between the cases in Spain and Croatia and that it was difficult to blame Baxter dialysers directly for the deaths because other factors, such as dialysis concentrates, tubing and needles, dialysing apparatus, and medication should also be investigated. He also said that the dialyser batches in Spain and Croatia were not the same. Vicente Bellenguer, President of Baxter Central and East Europe, said that they believed the results of recent safety testing by independent TÜV Product Service from Munich, Germany, released on Oct 9, which showed that the batch of Baxter dialysers used in Spain passed rigorous international ISO10993 biocompatibility standards. However, he announced that they would stop the delivery of the A series dialysers in Europe until the Croatian investigation was concluded. Baxter also created a panel of European nephrologists—led by Bernard Canuad, Lapeyronie University Hospital, Montpellier, France—to cooperate with all authorities investigating the deaths. On Oct 18, following the report of the two
deaths in Texas, Baxter announced an urgent worldwide recall of their dialyser series AF150, AF180, and AF220. Patricia O’ Hayer, a spokesperson for Baxter, told The Lancet that they have invited experts from TÜV Product Service to audit Baxter production lines in Ronneby in Sweden, which produced the dialysers used in Croatia and Spain, and in Miami Lakes in Florida. TUV’s report is expected later this week. She also said that their measures were only precautionary and that they were open to any test of their products. After the deaths in Spain, Pliva, a Croatian pharmaceutical company, which distributes Baxter dialysers, did not discontinue the sale of A-18 dialysers. Jasna Maric, a Pliva spokesperson, told The Lancet that they received written assurance from Baxter that the dialysers were safe. However immediately after the Ministry’s order to Croatia’s 44 haemodialysis centres on Oct 14, Pliva halted distribution of the dialysers until after the investigation and surrendered its dialyser shipment to the police. The company also announced that it had terminated its business contracts with Baxter, including purchase of all Baxter products. Igor Martinovic, a physician from one of the hospitals where deaths occurred and a haemodialysis patient told The Lancet that he had joined government investigators as vicepresident of the Croatian Association of Haemodialysis Patients. Martinovic said this tragic incident showed the importance of their efforts to establish a national register of haemodialysis patients. Martinovic assured the patients in Croatia that haemodialysis is safe: “It will take some time before the investigation is concluded, but I can say as a haemodialysis patient, physician, and investigator into this tragedy, that health professionals have done everything in their power to eliminate all possible risks, at the same time searching for the cause of deaths”. Ana Marus ˘ic
1431
For personal use. Only reproduce with permission from The Lancet Publishing Group.
NEWS Croatian Health Minister resigns after dialysis deaths
THE LANCET • Vol 358 • October 27, 2001
Medicine, the Croatian Institute of Public Health, and the Ministry of Interior. He also said that the committee contacted the US Food and Drug Administration after the death of two haemodialysis patients in Austin, Texas, on Oct 16.
Rights were not granted to include this image in electronic media. Please refer to the printed journal. AP
he Croatian Prime Minister, Ivica Racan, accepted the resignation of his Health Minister on Oct 23 in the wake of the deaths of 23 patients who died during or shortly after receiving haemodialysis between Oct 8–13. The Prime Minister said that an internal interim report from the health ministry showed that poor communication between the Ministry and Croatia’s health institutions led to an increase in the number of deaths. “How much of it rests with the manufacturer of dialysers and possibly how much on the distributor will be shown after the investigation”, added the Prime Minister. The government will also help families with compensation claims, he said. On Oct 13 the Health Minister, Ana Stavljenic-Rukavina, launched an investigation into the deaths of 23 patients who died in six medical centres in Croatia. The usual death rate among Croatia’s 2600 dialysis patients, who are mostly more than 60-years-old, is 5–7 per week. The former Minister told The Lancet that after examining the patient data the only common factor was the dialysis membrane—the A-15 and A-18 brands manufactured by the US company Baxter International. The Health Minister immediately ordered Croatia’s 44 dialysis centres to stop using the filters but this came too late for six patients in Pula, who died using the same dialysers on Oct 14. The dialysis-related deaths in Croatia happened 2 months after 12 similar deaths in Spain where Baxter A-18 dialysers were also implicated. Stavljenic-Rukavina also formed an investigative committee of nephrologists, forensic specialists, toxicologists, epidemiologists, and patient representatives, to take a closer look at the recent deaths. Vladimir Gasparovic, head of the haemodialysis centre at the Zagreb University Hospital Centre and member of the Ministry’s committee, told The Lancet that the necropsies of some of the patients were done and that the committee is now waiting for the results of toxicology tests done at several independent institutions including the Zagreb School of
T
Ana Stavljenic-Rukavina
On Oct 14 Baxter dispatched a specialist team to Croatia to work with the authorities to investigate the incident. At the press conference in Zagreb the following day, Jose Divino, Baxter Associate Medical Director for Europe, said that there were differences between the cases in Spain and Croatia and that it was difficult to blame Baxter dialysers directly for the deaths because other factors, such as dialysis concentrates, tubing and needles, dialysing apparatus, and medication should also be investigated. He also said that the dialyser batches in Spain and Croatia were not the same. Vicente Bellenguer, President of Baxter Central and East Europe, said that they believed the results of recent safety testing by independent TÜV Product Service from Munich, Germany, released on Oct 9, which showed that the batch of Baxter dialysers used in Spain passed rigorous international ISO10993 biocompatibility standards. However, he announced that they would stop the delivery of the A series dialysers in Europe until the Croatian investigation was concluded. Baxter also created a panel of European nephrologists—led by Bernard Canuad, Lapeyronie University Hospital, Montpellier, France—to cooperate with all authorities investigating the deaths. On Oct 18, following the report of the two
deaths in Texas, Baxter announced an urgent worldwide recall of their dialyser series AF150, AF180, and AF220. Patricia O’ Hayer, a spokesperson for Baxter, told The Lancet that they have invited experts from TÜV Product Service to audit Baxter production lines in Ronneby in Sweden, which produced the dialysers used in Croatia and Spain, and in Miami Lakes in Florida. TUV’s report is expected later this week. She also said that their measures were only precautionary and that they were open to any test of their products. After the deaths in Spain, Pliva, a Croatian pharmaceutical company, which distributes Baxter dialysers, did not discontinue the sale of A-18 dialysers. Jasna Maric, a Pliva spokesperson, told The Lancet that they received written assurance from Baxter that the dialysers were safe. However immediately after the Ministry’s order to Croatia’s 44 haemodialysis centres on Oct 14, Pliva halted distribution of the dialysers until after the investigation and surrendered its dialyser shipment to the police. The company also announced that it had terminated its business contracts with Baxter, including purchase of all Baxter products. Igor Martinovic, a physician from one of the hospitals where deaths occurred and a haemodialysis patient told The Lancet that he had joined government investigators as vicepresident of the Croatian Association of Haemodialysis Patients. Martinovic said this tragic incident showed the importance of their efforts to establish a national register of haemodialysis patients. Martinovic assured the patients in Croatia that haemodialysis is safe: “It will take some time before the investigation is concluded, but I can say as a haemodialysis patient, physician, and investigator into this tragedy, that health professionals have done everything in their power to eliminate all possible risks, at the same time searching for the cause of deaths”. Ana Marus ˘ic
1431
For personal use. Only reproduce with permission from The Lancet Publishing Group.