Compliance with the law and regulations?
With regard to Royal Decree 1800/2003, of 26th December, regulating medical gases, you should be aware that the oxygen produced by our generating plants is for "on site" application to patients, whilst bottling for subsequent commercial distribution is not authorised. For this reason, oxygen with a 93% purity level does not require authorisation to place it on the market as a medical product and it is not affected by Royal Decree RD 1800/2003. This Oxygen must and does meet the requirements of the European Pharmacopoeia.
For authorisation for the commissioning and legalisation of the plant, pressure devices and oxygen production and refilling, it is necessary to present a pressure device installation project for the production and refilling of medical oxygen. In compliance with the provisions of Royal Decree 154/2001 of 23rd July, for the commissioning of plants, and Royal Decree 2060/2008, of 12th December on Pressure Device Regulations.
Why is it that hospitals are not familiar with the oxygen option based on PSA (Pressure Swing Adsorption) technology?
Over the last few years, little information has been available on PSA (Pressure Swing Adsorption) technology, as a result many hospitals were not aware of this option. Today, we have medical customers using Ceimsa's PSA (Pressure Swing Adsorption) units as the only source of oxygen (for breathing, operating or any other hospital use), all of whom are highly satisfied given the fact that PSA technology is a sufficiently reliable and cost-effective solution.
Points you need to bear in mind should you decide to install a PSA (Pressure Swing Adorption) at your healthcare centre:
- The design of the molecular beds of the generator should feature spring pressure.
- The manufacturer should comply with all applicable PSA (Pressure Swing Adsorption) regulations and should have a Health Authority Operating Licence to Manufacture or Install Medical Products, granted by the Spanish Agency for Medicines and Medical Devices.
- The oxygen generators installed should have the appropriate medical device certificate, in compliance with Directive 93/42/EEC.
- The system quoted should have an oxygen compressor to fill cylinders to 200bar, operating at under 30 RPM and with a low temperature oxygen output.
- Before installing the system, the manufacturer or installer should be qualified to present a technical installation project, for authorisation for the plant commissioning and legalisation.
- A good technical support service is very important.