Caught in a sting
Execs appeared willing to make Chinese medical devices appear as European
Posted on 04 November 2012, Author: Bénédicte Williams
The Hungarian branch of global inspection, verification, testing and certification company SGS is one of several in Europe to have been accused of being ready to offer licences for potentially dangerous medical equipment, including hip implants, cardiac defibrillators and breast implants, following a joint investigation by UK newspaper The Daily Telegraph and the British Medical Journal published last week.
The allegations emerged after undercover reporters working with the British Medical Journal passed themselves off as representatives of a Chinese firm proposing hip implants for certification to commercial organisations charged with evaluating medical devices in Budapest, Slovakia, the Czech Republic, Greece and Turkey. The “metal-on-metal” implants involved were of a type similar to one that has already been withdrawn from a variety of European and American markets owing to safety concerns.
Falsifying origin alleged
Executives from SGS had “offered advice on how to market the questionable product” by certifying it as produced in the EU rather than in China, The Daily Telegraph wrote. The British Medical Journal also reported companies in other countries admitting that they were “on the side of the manufacturer and their products, not on the side of the patients” when it came to certifying products for medical use across Europe.
No we didn’t: SGS
SGS has denied the allegation, telling state news agency MTI that “an offer for licensing a dangerous implant was out of the question” and that the body did not start the licensing procedure or test the implants because it had not received enough information about the product from the supposed Chinese firm. SGS follows strict internal procedures and will not issue licences unless the case is carefully proven, the company told MTI.
Ministry defends side
A statement from the Health State Secretariat at the Human Resources Ministry on Saturday said there was no reason to assume that hip implants used in Hungary could create problems, or that organisations in the country are violating rules for the licensing of medical equipment.
- Dodgy medical implants getting approved – EasyBlog (earlsview.com)
- UK – Hunt vows to tackle hip implant scam (earlsview.com)
- Faulty medical implants investigation: Patients at risk from flaws in medical device rules, admit EU chiefs – Telegraph (earlsview.com)
- Faulty medical implants investigation: ‘We can help you label it European so China is not on packaging’ – Telegraph (earlsview.com)
- Faulty medical implants investigation: Patients treated ‘like guinea pigs’ – Telegraph (earlsview.com)
- Radio New Zealand : News : National : Hip implant probe sparks call for better NZ system (earlsview.com)
- Hip implant probe sparks call for better NZ system (radionz.co.nz)
- Faulty medical implants investigation: Patients’ health put at risk by unscrupulous EU regulators (telegraph.co.uk)
- The Pros and Cons of Adjustable Breast Implants (aboutplasticsurgery.com)
- Report: Sub-standard hip and knee replacements being licensed for use on NHS (itv.com)