Terumo Europe, manufacturer of over 600,000,000 hypodermic needles annually, is the victim of distortions and mixing up of facts and fiction. Being a manufacturer of essential medical devices, patient safety is Terumo’s first priority. To that aim, Terumo permanently executes studies on the quality of its products. By selectively quoting from certain studies, placing bits of information in a different context and spreading plain falsehoods, wrongfully the picture arose in the Netherlands and Belgium that Terumo medical devices would not meet the safety requirements.
Today (15 April 2015), the Dutch programme EenVandaag (‘One Today’) has announced that it will once again focus on Terumo. Terumo Europe has immediately analysed the broadcast announcement and has again identified a number of incorrect theses.
Following an earlier broadcast of 23 March 2015, named “Safety of injection needles endangered”, on possible glue residue in injection needles, Terumo has lost all confidence that this broadcast wants to give a truthful representation of the facts. The company has thus decided to inform the competent authority in Belgium on the new initiative of EenVandaag and has shared with them all facts and figures that it disposes of
Terumo Europe has indeed noticed that earlier investigations dating from 2012 on the possibility that a byproduct of epoxy glue (BADGE) might be released in the needles, has been used to depict a completely incorrect picture of the facts. EenVandaag has done this based on a testimonial of a temporary worker (a self-employed free-lancer) who worked from July 2013 till January 31, 2014 in Terumo Europe’s Quality Assurance Department in Leuven and who has stolen internal mails and other documents. As a result, the picture arose that Terumo hypodermic needles would not meet the safety requirements.
Terumo has carefully analysed the concerned broadcast and has found more than 10 misstatements, false interpretations or distortions.
Some remarkable examples
- One image of the broadcast sticking in mind is the magnified image of a hypodermic needle leaking a liquid. In the broadcast, it is stated that the displayed needle was taken from the production line after production and that the visible liquid is 100% glue. Terumo Europe, however, made these recordings themselves for a test study of the behavior of silicone with needles. The needle is not removed from the production line and there simply is no glue. The application of silicone on needles is a standard procedure in order to make the needles glide better and to make pricking less painful.
- The producers of the broadcast refer to a report of the Dutch Health Council of March 19, 2014 which would say: "Bisphenol A and BADGE are suspected to be harmful to reproduction, metabolism and the immune system.” However, in this report, one can read literally: “The use of Bisphenol A has caused a lot of worries because this substance is suspected to be harmful to reproduction and development, metabolism and the immune system.”
There is no mention of BADGE, the glue residue that in some cases does not cure during curing of the epoxy glue.
- The broadcast showed no cross-section of a hypodermic needle, as EenVandaag claimed, but a cross-section of the hub. Here is exactly where the glue is supposed to be in order to attach the needle to the plastic hub.
In a most refined manner, facts and untruths are mixed together in such a way that this leads to an incorrect picture. Unfortunately, without doing justice to the facts and intentions of Terumo. As a result, patients, nurses and doctors were unnecessarily worried and some vaccination programmes in the Netherlands have possibly even been hindered.
In the meantime Terumo has started additional analyses on possible glue residue in hypodermic needles. Terumo wishes to exercise the greatest care and to only bring out the research results once the research programme has been fully completed and validated. In addition to that, Terumo fully co-operates with the investigations currently executed by the Belgian and Dutch authorities. The result of these studies, is to be expected in a number of weeks. Terumo has full confidence in a good outcome of these investigations. Our products meet the highest quality standards and hold no risks for the patient.
In recent weeks, Terumo has also looked into other studies and topics that were discussed during internal quality analyses and which, if taken out of context, could be used to draw once again a false image of Terumo.
- Terumo has heard from customers that they were approached by the producers of EenVandaag to make statements about a specific complaint submitted by them. In December 2013, Terumo indeed received a complaint from a customer that a certain supply contained hypodermic needles that were not sharp enough. Terumo has done extensive research on the sharpness of the concerned production run of needles and no abnormalities were identified beyond the established specifications. The results of this extensive research were shared with the client.
Again, the EenVandaag reporting creates a misleading image of the truth. The degree of damaged or blunt needles in the past five years corresponds to 0.02 complaints per million sold units or 2 complaints per 100,000,000 sold units.
- On Monday 13 April 2015 Terumo Europe received an e-mail from EenVandaag in which the editors ask several questions not related to the previously aired documentary. Terumo requested some clarifications in order to avoid that a distorted image of reality would be created. Terumo Europe has sent the questions of EenVandaag, accompanied by information from Terumo Europe regarding the topics, to the competent authorities in Belgium (FAGG) and the notified body (TüV Rheinland), to enable them to conduct further investigations.
Following EenVandaag’s announcement of a second documentary, Terumo Europe has immediately analyzed the information available on the website of EenVandaag and has again identified several wrong interpretations.
- EenVandaag publishes on its website: “according to the wisthleblower, notifications about this kinds of incidents are taken out of the official quality registration systems Pilgrim and CAPA, and thus nothing can be found during an inspection visit”.
No non-conformity and/or CAPA (Corrective Actions and Preventive Actions) can be removed out of the validated quality registration system. That is technically impossible.
- Regarding the paragraph: “ Tens of millions of FDA penalties for Terumo”, Terumo can state the following. The whistleblower declares: “The problem is that they do not have the same power as the American FDA”.
The FDA inspected the Terumo Europe factory in 2013 and found no concerns and had zero inspectional observations.
The EenVandaag statement that the FDA fined Terumo in 2010 for catheter quality issues is completely wrong. The factory related to the fines is in Ann Arbor, Michigan, U.S.A. and does not manufacture any catheters or stents.
EenVandaag falsely claims there was an incident with a heart catheter that tipped the U.S. regulators to visit Ann Arbor. Heart catheters are not manufactured in Ann Arbor and there is no record of any incident.
EenVandaag incorrectly claims that delivery prohibitions exist for the Ann Arbor plant. The fines for the factory in Ann Arbor were related to documentation and system issues and not product quality. No products were recalled as part of the FDA’s action and the plant was allowed to continue manufacturing and selling products. Further, in February 2015 the FDA declared the factory to be in compliance with the quality system regulations after a two week inspection. European authorities using the notified body BSI have inspected the plant yearly and found no significant issues.
- EenVandaag states: “Terumo acknowledges that unintentionally there might be glue coming out of the needles, but says that ‘it cannot harm’”.
Terumo has never acknowledged this. There is simply no glue coming out of the injection needle.
Terumo Europe is of the opinion that a free, independent press is of fundamental importance for the functioning of a democracy and crucial for an independent, public judgement of organisations, including companies like Terumo.
However, Terumo Europe regrets that it has not received the opportunity to give full transparency, but instead has been confronted twice with a pre-determined script in which no place was left for Terumo’s contribution, based on facts and figures.
Geert Lambrechts, Communications Manager EMEA+32 473 63 78 92Geert.firstname.lastname@example.org