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Syringes of the frequently used brand Terumo should be called back immediately. They could unintentionally leak epoxy resin, claim experts in the Dutch current affairs program Dossier EenVandaag.
Millions of these needles are being used in hospitals, health care institutions and for vaccination programmes. The Dutch Health Inspection and the American Food and Drug Administration have announced an investigation into this matter.
These alarming production issues at Terumo Europe have been known for years, but so far nothing has been done with the information. The syringes are still being sold to hospitals, clinics, and to big farmaceutical companies like GlaxoSmithKline, Sanofi Pasteur MSD and Merck. For the sake of patient safety, a whistleblower brought information on the scandal to Dossier EenVandaag, after the company refused to tackle the problem internally.
Professor in Health Care Safety Jan Klein believes there should be immediate action: “I think this company should abandon production. They should open up to anyone who is involved, and only resume production if these issues have been solved to a sustainable level. If necessary all these needles should be called back. They shouldn't be used.”
This concerns 'K-pack II' syringes made by the Japanese manufacturer Terumo. Each month millions of these syringes are produced in Leuven in Belgium. There are also known resin issues with syringes of the type 'Neolus'.
The syringes are sold in Europe and the United States. As read in leaked internal documents, photographs and video material, the epoxy glue that is used to attach the needle does not harden properly, which means it can enter the needle and the bloodstream of the patient. Docters that we have spoken to are not only worried about the consistence of the glue, but also about the possibility that 'fragments' can be injected into blood vessels. According to them could result into bloodclots, with serious consequences like thrombosis or brain haemorrhage.
The whistleblower tells Dossier Eenvandaag that the issues have existed for more than 4 years, but that everything has been kept behind closed doors;” You couldn't find anything within our quality-evaluation system, it's like a cover-up. Everyone has known about it for a long time, but no-one dare s to open their mouth. For years they have been messing with the health of patients. They only think about money, about low production costs and are lying to customers.”
The Netherlands is the only European country that advises not to use the temporarily discredited syringes of Terumo brand. Says the company Terumo Europe.
According to the company, the needles, which can leak glue, are still goign to be used in all other countries. "As far as we have been informed, the advice is only limited to the Netherlands. The production and sale of the needles will continue normally," said Terumo.