Investigation into possible problems with hypodermic needles reveals negligible risk
Hypodermic needles produced by Terumo and other manufacturers pose negligible health risks. There is no reason not to use these needles. Nevertheless, Terumo should improve its quality control procedures for the production and distribution of its hypodermic needles. These are some of the findings of an investigation conducted by the Dutch National Institute for Public Health and the Environment (RIVM) on behalf of the Dutch Health Care Inspectorate (IGZ). The investigation included a number of inspection visits to Terumo’s facilities in Belgium.
On 23 March 2015, the Dutch current affairs TV programme EenVandaag broadcast a report about the possible presence of traces of glue in hypodermic needles manufactured by Terumo. These allegations prompted IGZ to commission RIVM to investigate whether use of these needles poses a risk to patient safety. An international inspection team then visited Terumo’s production facility and distribution centre in Belgium.
Conclusions of RIVM’s investigation
RIVM examined approx. 7,000 hypodermic needles produced by Terumo as well other manufacturers. Less than 1% of the needles investigated were found to contain small traces of hardened glue. No needles were found that were completely blocked or that contained non-hardened, liquid glue. In collaboration with British and Belgian experts, RIVM also investigated whether traces of glue in hypodermic needles pose a potential risk to patient health. RIVM has concluded that this risk is negligible. This also applies to the substances found in the glue.
In addition to small quantities of hardened glue, plastic particles were also found in needles produced by various other manufacturers. When the needles are flushed, these particles are released in very small quantities, which are not even detectable under a microscope. However, the quantity of particles released remains below the applicable limit value for injection solutions. As a result, these plastic particles are not expected to pose any health risks either.
Inspections at Terumo’s production facility
IGZ and the Belgian Federal Agency for Medicines and Health Products (FAMHP) conducted a number of inspections at Terumo’s production facility in Leuven, Belgium. The inspections revealed that Terumo needs to improve a number of aspects of its needle production process. The company also needs to optimize its quality management system. The shortcomings found do not pose any risks to public health.
Inspections at Terumo’s distribution centre
On 15 April 2015, EenVandaag broadcast a second report about alleged problems with the packaging of sterile medical devices at Terumo’s distribution centre in Genk, Belgium. These problems could not be confirmed during the inspection visit by IGZ and FAMHP, although the inspection authorities did find that Terumo also needs to improve its quality management system at its distribution centre.
Whistle-blower supplies valuable information
Although the risks to patient safety turned out to be negligible, IGZ appreciates being contacted (anonymously) by the whistle-blower who originally approached the producers of EenVandaag. This allowed IGZ to perform a targeted investigation which revealed that Terumo needs to improve its quality management systems. In addition, IGZ and FAMHP will liaise with manufacturers of hypodermic needles to evaluate the inspection findings and discuss possible improvements.