Half a year after the government’s order, the 1,000 emergency respirators that were to go to the hospitals have still not been delivered.
The respirators, which have a total cost of NOK 60 million, were scheduled to be distributed to Norwegian hospitals by May. The delay is due to the fact that all emergency respirators must be quality-labeled. Without CE marking, the government fears loss of reputation and that it may seem as if people’s lives are being endangered, Bergens Tidende writes.
“The requirement that the respirators must be CE marked, came as a surprise in mid-May and involves a time-consuming and costly additional process”, said research director Hanne Bjørk at the Armed Forces Research Institute to VG then.
It is now likely that many of the devices may have been given as assistance to organizations or poor countries. Giving off devices that are not quality-checked and CE-marked can be “reputationally problematic for Norway”, writes State Secretary Anne Grethe Erlandsen in the Ministry of Health and Care Services in an email to BT.
The process of CE marking normally takes one to two years for medical equipments. Extreme requirements are set for documentation and it must be ensured that the product meets all standards for this type of equipment. Everything in the production process must be traceable. This applies to all parts, including which tool is used and how hard each screw or nut is attached.
© NTB Scanpix / #Norway Today