Terumo Europe is once again the victim of distortions and a mix up of facts and fiction. The new broadcast by EenVandaag is based on unverified claims and selective quotations from documents. Furthermore, the broadcast places information in an incorrect context and spreads downright falsehoods. Terumo Europe cannot accept that wrongly the image is created that in the Netherlands and Belgium Terumo’s medical devices would not meet the strictest safety standards.
EenVandaag’s broadcast of 15 April 2015 is full of false claims and inaccuracies that unfortunately may cause unrest among patients. Terumo Europe feels compelled to rectify the many false claims and provides an overview of some important elements below.
In the broadcast, it is stated that “Terumo Europe might sell stents and catheters that are potentially not sterile”. It is absolutely incorrect to state that Terumo Europe would sell not sterile stents and catheters.
All stents and catheters sold by Terumo Europe are sterilized using validated methods and standards.
At the slightest doubt, all conventional procedures are activated to ensure patient safety. In this regard a recall action was set up at the beginning of April for a specific type of catheters: the Radifocus Optitorque catheter. During quality research, it became apparent that a ventilator in the sterilization tank was not working properly during the sterilization cycle. All biological indicators were sterile and all parameters were within the predefined specifications. Nevertheless, Terumo Europe voluntarily recalled the remaining units as a precautionary measure. This proves that, even at the slightest sign of doubt, Terumo Europe does not take any risks.
Among other things, EenVandaag states that, when the packaging is damaged, it is impossible to verify whether a product is still sterile and should be rejected. In addition, the television programme claims that Terumo Europe would not be working according to the standard directives when handling the products in damaged packages.
In order to separate facts from fiction, one should be aware of the fact that a stent or catheter is packaged in no less than 3 separate packages.
- The sterile packaging or blister containing the medical device- The unit box, being the second container and the minimal selling unit.- The transportation box, being the third package and containing one or several unit boxes.
When handling returned goods, Terumo Europe works according to the rules set out by the Eucomed Good Distribution Package (GDP).
Returned goods are inspected at unit box level. If these unit boxes have been opened or are damaged, the unit box - including the complete content – is immediately separated (physically and within SAP) and destroyed on a quarterly basis. All of this takes place according to an established procedure, whereby all returned items are being checked by trained quality inspectors, who work autonomously.
It was further stated in the broadcast that "a CAPA is sometimes registered into the system to be removed again out of the system the next day."
The statement regarding the removal of a CAPA from the system is totally wrong. Not a single non-conformity and / or CAPA (Corrective Actions and Preventive Actions) can be removed from the validated quality registration system. That is simply impossible. Every change is traceable, removing is impossible. Terumo meets the highest software validations standards.
The documentary states that “after an incident with a heart catheter, inspectors have visited the Terumo Cardiovascular Systems in Ann Arbor, Michigan”, and that “the FDA concluded that the company’s quality system was not functioning well”.
The EenVandaag statement that the FDA fined Terumo in 2010 for catheter quality issues is completely wrong. The factory related to the fines (Ann Arbor) does not manufacture any catheters or stents.
The conclusion of the FDA about the quality system concerns the absence of product design files in the documentation system and thus has nothing to do with an incident with a heart catheter.
European authorities using the notified body BSI have inspected the plant annually and found no significant problems.
The US-FDA conducted an inspection of Terumo Europe, in 2013. No observations were cited at the conclusion of the inspection.
As announced earlier, EenVandaag has used investigations dating from 2012 on the possibility that residue of epoxy glue might be released in the needles, to depict a completely incorrect representation of the facts. EenVandaag has done this based on a testimonial of a temporary worker. The second documentary of EenVandaag repeats that “Terumo acknowledges that unintentionally glue can come out of the needle, but states this is ‘harmless’.Terumo has never acknowledged this. There is simply no glue coming out of the injection needle. A component of glue residue can eventually separate itself from the glue. It concerns very small amounts. This is inherent to epoxy glues.The images used to suggest that, do not show glue, but silicone. Terumo Europe made these recordings themselves for a test study on the behavior of silicone with injection needles. The application of silicone on needles is a standard procedure in order to make the needles glide better and to make pricking less painful.
Terumo fully co-operates with the investigations currently executed by the Belgian and Dutch authorities. The results of these studies, are to be expected in a number of weeks. Terumo has full confidence in a good outcome of these investigations.Finally, it is untrue to state that Terumo Europe did not want to react to the questions of EenVandaag. On Monday 13 April 2015 Terumo Europe received an e-mail from EenVandaag with several questions. Terumo Europe asked several times for more clarity, to prevent the editors from giving again a distorted depiction of reality. These questions remained unanswered. Terumo has forwarded the questions, accompanied by the information of Terumo, to the competent authority in Belgium (FAGG) and the notified body (TüV Rheinland), to enable them to investigate this further.“Our products meet the highest quality standards and patient safety always comes in first place”, declares Kyo Nishikawa, Managing Director of Terumo Europe. “I regret that EenVandaag did not grant Terumo the opportunity to give full transparency. Instead we have been confronted with a pre-determined script, apparently aiming to discredit Terumo and its collaborators and create unrest among our clients, healthcare professionals and patients. We will continue to deliver highly qualitative products and to work in all transparency”.
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On 16 April 2015 the Flemish Public Broadcast televison programme Ter Zake aired a documentary about Terumo. This documentary can be viewed by clicking on the following link: http://www.canvas.be/programmas/terzake/9c6adfdc-9717-4788-ac09-cf59d97e659c#alleafleveringen
Geert Lambrechts, Communications Manager EMEA+32 473 63 78 92Geert.firstname.lastname@example.org www.terumo-europe.com
Terumo Europe, founded in 1971, is a core player in the EMEA healthcare market by providing best in class quality medical products and services. We are a strong actor of the Terumo Group by contributing to innovation and sustainable growth. Terumo Europe produces, distributes, markets and sells a vast range of medical devices in four main business units: Hospital and Laboratory Systems, Global Pharmaceutical Solutions, Interventional Systems and Cardio Vascular Products. Terumo Europe EMEA headquarters and production facilities are located in Haasrode (Belgium), production facility in Knowsley (UK) and sales units across EMEA. Please visit www.terumo-europe.com for more information.