The Ministry of Health in Luxembourg has registered all vaccine storage and transport systems manufactured by B Medical Systems as medical devices, conforming to the safety and health standards of the European Union. This groundbreaking achievement emphasizes the unique and necessary role cold chain equipment plays in keeping vaccines safe and effective for children across the world. It also highlights B Medical Systems’ commitment to manufacture high-quality and safe solutions for the full schedule of childhood vaccines.
“We are delighted that our vaccine cold chain solutions passed the regulatory assessment of the European Union. Obtaining the classification as medical devices is a symbol of quality, which recognizes years of research and development in the production of reliable products aiming to prevent vaccine-preventable diseases and save lives”, said Luc Provost, CEO of B Medical Systems.
For over 35 years, B Medical Systems has been designing, manufacturing and distributing medical equipment that keep life-saving vaccines safe and steady at the WHO-recommended temperatures until administration. Its history in vaccine cold chain started in 1979, when the World Health Organization approached the company – previously known as Electrolux Medical Systems – to provide a solution to their problems in safely storing and transporting vaccines around the world.
Today, B Medical Systems offers an industry leading range of 26 vaccine cold chain units. More than a hundred countries across the globe have adopted the technology. With the classification and registration of its solutions as medical devices, the company has succeeded in accomplishing yet another pioneering achievement.
Safety & Reliability
To manufacture its refrigerators, freezers and transport boxes, B Medical Systems employs the unique technology of rotational moulding (or rotomoulding). The automated system produces precision devices in polypropylene. They provide highly resistance to corrosion, shocks, and extreme temperatures, while maintaining constant temperatures of 2 – 8°C. Further, the real-time data loggers monitor the performance and temperature of each unit, guaranteeing that every vaccine remains within safe and effective temperatures.
In Europe, the regulation that governs the market of medical devices is Directive 93/42/EEC. It establishes the essential requirements and standards for the manufacture, design, packaging and distribution of the medical devices, with the aim of ensuring patient safety. According to the Directive, a notified body must proceed with a conformity assessment and the local competent authority must approve the manufacturer’s medical devices – and the quality management system – before circulating freely within the EU market with the CE Marking.
B Medical Systems’ vaccine cold chain solutions also conform to the World Health Organization’s Performance, Quality, and Safety Standards, and Gavi – the Vaccine Alliance’s CCEOP program.
