As of 17 April 2015, the Dutch Health and Youth Care Inspectorate has revoked its advice to temporarily refrain from using two types of hypodermic needle manufactured by the company Terumo. This decision was taken further to an investigation by the Dutch National Institute for Public Health and the Environment (RIVM).
Apart from the negligible health risk, the investigation also highlighted the absence of a standard containing requirements applicable to glue in hypodermic needles. The Inspectorate subsequently promised to share the investigation results and recommendations with manufacturers.
- Investigation into possible problems with hypodermic needles
Meeting for manufacturers of hypodermic needles
IGZ organised a well-attended international meeting for manufacturers of hypodermic needles on 15 January 2016. Together with the RIVM and the Belgian Inspectorate, the results of the investigation were shared with the manufacturers. The Netherlands Standardization Institute (NEN) explained how standards are developed.
IGZ called upon the manufacturers to amend the existing ISO 7864 standard to include requirements concerning glue in hypodermic needles. IGZ additionally stressed the importance of manufacturers monitoring the quality of their products and continuing to improve their production processes.
IGZ is pleased with the interest that manufacturers showed in the meeting. We can look back on a successful day where considerable attention was devoted to the subject under discussion and the talks were constructive. The meeting marks IGZ’s closure of the case.
The potential problems with Terumo hypodermic needles were brought to the Inspectorate’s attention by the television current affairs programme EenVandaag. Its producers were contacted by a ‘whistleblower’ who alleges that Terumo knows that its products carry traces of glue but has nevertheless continued to distribute them. The issue was brought to public attention in an edition broadcast on 23 March 2015, since when the Inspectorate has issued six field bulletins. You can find these bulletins in the news section.