The private certification institute in Nová Dubnica has not made any mistakes, although it had promised to “exceed the rules” during the control of new artificial joints, at least according to the state-run Office for Normalisation, Metrology and Testing (ONMT), which has audited the company, the Sme daily reported on November 3.
The case involving dubious certificates given for artificial joints was uncovered by the British daily The Daily Telegraph, whose reporters pretended to be representatives of a fictitious Chinese firm trying to get their products on the European market. The reporters claim they received permission even though they had offered a dangerous joint.
“The Electro-technical Research and Project Institute could not know that [the joints] are dangerous products since it does not have access to the database of dangerous medical devices,” said Katarína Lengyelová, head of the office of the ONMT, as quoted by Sme.
She added that the institute could learn about the joints only after receiving the necessary documentation.
Yet, the British reporters say that they sent all necessary documents to the institute after the meeting, including information about the joints. The Nová Dubnica-based institute still assured them they would receive the certificate, Sme wrote.
The ONMT has not contacted the reporters and has not checked their claims.
“We do not agree with tendentiously provided information which should evoke the feeling that in ‘former communist countries’ there are notified bodies able to give certification for a medical device without checking its technical documentation and subsequent control of the product,” said Lengyelová, as quoted by Sme.
For more information about this story please see: Slovakia accused of licensing dangerous replacement joints made in Asia
Compiled by Radka Minarechová from press reports
The Slovak Spectator cannot vouch for the accuracy of the information presented in its Flash News postings.
5. Nov 2012 at 14:00