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Medical devicesInvestigation into possible problems with hypodermic needles

News item | 23-03-2015

The Health Care Inspectorate is conducting a full investigation into possible production errors involving hypodermic needles, further to information received from the producers of the television programme EenVandaag. An edition of this programme in which allegations of malpractice on the part of a manufacturer are made will be broadcast this evening [23 March 2015].

Action by the Inspectorate

The limited information provided to the Inspectorate by the producers of EenVandaag was enough to prompt an immediate investigation into the nature of any problems, and to seek consultation with our European partners. At 23:10 on the evening of 23 March, the Inspectorate learned that allegations concern a Japanese manufacturer with production facilities in Belgium and the United Kingdom. This manufacturer has asserted that there is absolutely no risk to patient safety. Thus far, the Inspectorate itself has received no reports or information about any problems with the hypodermic needles concerned. Nevertheless, we take the information passed to us by EenVandaag extremely seriously. At the Inspectorate’s request, Belgian authorities will visit the Terumo factories in their country at the earliest possible opportunity. The Inspectorate has made arrangements with the National Institute of Public Health and the Environment for samples of the needles to be tested in its laboratories. Thus far, there is no reason to order a product withdrawal. If the investigation reveals any risk to patient safety, the Inspectorate will of course take immediate and appropriate action.