Translation errors can be more costly and dangerous than most people can imagine. When it comes to medical devices, patient safety is always a major concern and, as a result, so is the liability of medical device manufacturers. The safe use of medical devices is regulated by governmental agencies in many countries and incidents associated with the incorrect use of devices are tracked and reported periodically. Medical device manufacturers are very sensitive to risk assessment and mitigation.
Yet, when it comes to minimizing risk, not all medical device manufacturers consider medical translation to be an important outsourced activity, despite the fact that Notified Bodies consider it to be critical. Below are two examples of frightening incidents that remind us how critical this outsourced activity can be and the far reaching effect of translation errors.
The first example takes us to France, between 2004 and 2005, in a hospital near Epinal where men suffering from prostate cancer received massive overdoses of radiation treatment. As a result, four patients died and dozens of other patients were also affected.
The second incident took place a few years later, between May 2006 and March 2007, in a hospital in Berlin. In this instance, German newspapers reported an incident involving 47 consecutive patients. Orthopedic surgeons in this German hospital had erroneously implanted femoral components for total knee replacements in a non-cemented fashion, although these specific implants had been designed for cemented use only.
Translation Errors – What Happened and What Went Wrong?
The French Hospital Incident
So, what exactly happened? In this instance, the Inspection Générale des Affaires Sociales (IGAS), the French Healthcare Regulator, proceeded to a root cause analysis and determined that the incidents were due to serious medical translation issues. It appeared that the software defining the doses to be administered to patients had not been localized (translated) by the US medical device manufacturer and that all software messages, menus, and the Graphic User Interface (GUI) itself had been delivered to the French hospital in English only. A user manual in French was not available either. So the French hospital’s administration relied on bilingual staff members who used the software to provide a medical translation of the software messages and determine the appropriate doses to be administered.
Any professional translator or language service provider will tell you that bilingual staff members — whether in a hospital or working for an affiliate or a subsidiary — are not qualified to translate critical technical content, especially when the lives of patients are at risk. A professional medical translation goes through a very complex process. It follows strict procedures and numerous quality control steps. A self-proclaimed bilingual who needs to use a dictionary or go on-line to find the medical translation of the terms he or she is translating will struggle through the medical documents being translated and will easily make translation errors. Furthermore, there is no quality control nor established processes to verify the accuracy of the translation.
The same is true with “free” online translation services such as Google Translate. While convenient to understand the gist of a simple message, article, or email, such services should never be used for critical medical translation, especially when the lives of patients are at risk. Only a professional language service provider can handle such types of complex translations, in particular a language service provider that specializes in medical translation (as opposed to one who offers medical translation in addition to many other services).
Back to our French hospital incident. The bilingual staff members asked to translate the English software messages into French made critical translation errors which led to the hospital administering radiation overdoses for over a year. As a result, four prostate cancer patients died and dozens of other patients were also critically affected. Had the software and associated information been translated by a professional language service provider, as required by law, the staff at the hospital would have been able to administer the correct doses of radiation. In this particular instance, one can safely assume that a medical translation performed by a professional language service provider would have saved at least four lives.
The German Hospital Incident
In the case of the Berlin hospital, medical translation errors are again to be blamed for 47 consecutive erroneous implantations of total knee arthroplasties. But what exactly happened in this case? The disputed US-manufactured knee prosthesis was available in two different versions, for use with or without cement. The “non-modular cemented” version was introduced at the Sankt-Hedwig Hospital in Berlin in May 2006. A root cause analysis by the German authorities revealed that one of the contributing factors leading to the wrong use of this implant was related to the original outer package being labeled in English and not in German.
The German law governing medical devices required that all devices be delivered with instructions for use in German. In this case, the US device manufacturer of the knee prosthesis had had the IFU professionally translated into German. The German IFU was delivered to the hospital inside the package. But the outer packaging had been left in English. Since the information on the outer packaging was not translated, the Berlin hospital asked a staff member to provide a medical translation of the packaging into German. Stickers were then printed with the German translation (without any quality control) and stickers with the German medical translation “without cement” were added to the package labeling of the “non-modular cemented” devices. It appears that the hospital staff member misinterpreted the words “non-modular cemented” as “non cemented” and translated it in German as zementfrei (“not requiring cement” or “without cement”). As a result of this incorrect medical translation, labels saying “not requiring cement” were added to the boxes of the “non-modular cemented” devices. The prostheses were then implanted without cement (as indicated on the incorrect German sticker) and caused pain and suffering for 47 patients. The hospital had to offer these affected patients costly remedial surgeries. And, both the US device manufacturer and the hospital were sued and had to pay large compensation claims. In this scenario translation errors cost multiple institutions millions.
Why was the IFU Translated into German and Not the Outside Packaging?
In the US, the FDA clearly stipulates that all labeling of medical products used in the US must be available in English whether they are manufactured in the US or imported from another country. The terms “label” and “labeling” are specifically defined as “display of written, printed, or graphic matter upon the immediate container of any article…” and “all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers…” The German law regulating the use of medical devices also required that product information, particularly safety issues, be provided in German. However, this German regulation did not specifically demand that the outer packaging of medical devices be available in German, only the IFU. As a result, the US medical device manufacturer of these knee prostheses had hired a professional language service provider for the medical translation of the IFU but not for the outer packaging. As outlined in the present case, the English language package labeling of the arthroplasty implant was the basis of a wrong medical translation of the label and thus led to an improper implantation of total knee prostheses. From a human failure perspective, the distinct coating properties between the cemented and non-cemented versions of the femoral component (porous vs. smooth surface) were neither recognized by the instrumenting personnel, nor by the responsible surgeon at the time of surgery.