Depois dos problemas recentes ocorridos com Guidant Corp, que teve de retirar do mercado 100 mil desfribrilhadores portáteis, estando em curso uma complicada operação para a substituição de 28 mil pacemakers defeituosos implantados em doentes, surgem agora problemas graves com as bombas de infusão volumétrica Colleague, fabricadas pela Baxter International depois da morte de três doentes e da ocorrência de graves complicações com outros seis (as bombas interrompem a administração devido a problemas de software, concepção e desenho do equipamento) (link)
Depois dos problemas recentes ocorridos com Guidant Corp, que teve de retirar do mercado 100 mil desfribrilhadores portáteis, estando em curso uma complicada operação para a substituição de 28 mil pacemakers defeituosos implantados em doentes, surgem agora problemas graves com as bombas de infusão volumétrica Colleague, fabricadas pela Baxter International depois da morte de três doentes e da ocorrência de graves complicações com outros seis (as bombas interrompem a administração devido a problemas de software, concepção e desenho do equipamento) (link)
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F.D.A. Orders Recall of Intravenous Pumps
- The Food and Drug Administration on Thursday announced the recall of 206,000 pumps that deliver medicines intravenously to patients. The announcement was made after three people died and six became seriously ill when the infusion pumps unexpectedly shut down.
The machines, made by Baxter International and known as Colleague volumetric infusion pumps, shut down for a variety of software, wiring and design reasons. One of the most basic problems is that the "On/Off" key is so close to the "Start" key that nurses may inadvertently turn the machines off when they actually intend to begin drug therapy, the agency said.
"We've received hundreds of complaints from hospitals about these pumps," said Timothy Ulatowski, director of the office of compliance in the F.D.A.'s device center. "That's extraordinary."
Because some hospitals depend entirely on the pumps, the agency is not ordering that they all be sidelined. Instead, the agency is asking hospitals and other users to employ other machines in critical care cases if possible, and to monitor the machines closely, Mr. Ulatowski said. If the machines shut down in particular ways, they must be taken out of service, he said.
The agency termed the recall Class 1, its most serious classification and one that involves "a reasonable probability that using the affected product will cause serious injury or death."
About two dozen such recalls occur each year, Mr. Ulatowski said. The Baxter recall was unique, however, because the F.D.A. issued a press release and set up interviews with the news media to explain its actions.
"We've never issued a press release in the past on something like this," Mr. Ulatowski said. "In the past, the companies were given the opportunity to be the one to issue press releases, and they always did."
Lester M. Crawford, the new F.D.A. commissioner who was confirmed Monday by the Senate, has promised that the agency will become more transparent and begin speaking more directly to patients and doctors about the known and suspected risks of medicines and devices, often by using the news media, instead of allowing companies to speak for the agency.
The greater public attention may also encourage other companies to be more careful in their operations for fear of negative publicity.
"We want other companies to perk up and take note," Mr. Ulatowski said.
Deborah Spak, a Baxter International spokeswoman, said that the company sent a letter in March to its customers warning of problems with the infusion pumps.
Mr. Ulatowski said that the delay since March resulted because the agency had to inspect Baxter's plant and conduct its own tests to determine the seriousness of the problems. The agency also decided to order a recall to force Baxter to account for each suspect machine and report its findings to the agency. Such a recall also initiates a broad review of Baxter's manufacturing operations, Mr. Ulatowski said.
"Whenever you have a recall, that puts into motion a lot of activities at F.D.A.," Mr. Ulatowski said. "We look at trying to identify this problem and fixing the root cause of the problem, and taking a look at how the company operates, their manufacturing and their decision process when they get complaints."
Ms. Spak said that Baxter was changing the design of its pump. The company has stopped shipping new pumps, she said.
NY Times. 22.07.05
Prova de Mestrado em Saúde Pública
18 de Julho 2005
Requerida pelo Licenciado Jorge Luciano Leite Monteiro para discussão e defesa de uma dissertação original subordinada ao título “Importância da lavagem das mãos no controlo da infecção hospitalar", marcada para o dia 18 de Julho de 2005, às 14.30 horas na Aula Magna desta Faculdade.
Para não falar nos desastres ocorridos com os medicamentos.
É já a seguir. É já a seguir ...
Hoje são 25 Julho 2005.
Não tivemos a possibilidade de assistir a tão interessante dissertação.
Já a minha avozinha dizia que não havia melhor do que o sabão azul e branco.
Gostávamos de saber a nota final do licenciado luciano.
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