Medical Rules about Oxygen: definition and procedures
Medical oxygen is a type of oxygen used for reviving, anesthesia and therapy in the medical field. Unless the composition adheres to certain values, the product cannot be used or commercialized as medical oxygen. To regulate the use of such gases in hospitals, reference is made to certain statutory law like the “Directive 2001/83/EC” as well as the “European Pharmacopoeia”. Both these bodies are intended to regulate the use of gas in hospitals. These laws require operators to follow certain safety procedures necessary to obtain the production authorization for sales. Before the companies can legally trade or sell such gas, the companies must apply and get authorization at “State Drug Agency” which is the only institute with decision making powers.
What does the statutory law indicate about medical oxygen uses?
The statutory law on medical gas obligates the companies that produce primary gases to verify, among other things, the degree of medical oxygen purity, as well as its major pollutants such as carbon monoxide, carbon dioxide and moisture content. The manufacturers have to comply with some indicated limits for each component analyzed in order to obtain the marketing authorization.
For secondary producers, they currently require only analysis of the security and humidity in the containers of compressed oxygen.
What exactly does medical oxygen mean?
Medical oxygen is considered a drug and is usually administered by a paramedic in a pre-hospital setting or by a nurse, respiratory therapist or doctor in a hospital. It can also be prescribed for home use by a doctor.
The law mentions the term “medical oxygen”, which can be easily understood with this formula. In practice, oxygen can be marketed as medical oxygen if it satisfies the following parameters for the purity and the main pollutants:
| COMPOUND | LIMIT |
| OXYGEN PURITY | >= 99,5% V/V |
| CARBON MONOXID | <= 5 ppm V/V |
| CARBON DIOXIDE | <= 300 ppm V/V |
| WATER | <= 67 ppm V/V |
Technologies approved by the law
Referring to the measurement of the individual components, we must refer to a second table. In one side we find the compound (chemical species which must be determined during a chemical analysis) and in the other, the technology. The regulation on the medical oxygen allows the measurement of the individual compounds using the following measuring principles:
| COMPOUND | PRINCIPLE |
| OXYGEN TITLE | Paramagnetic |
| CARBON MONOXIDE | Infrared |
| CARBON DIOXIDE | Infrared |
| WATER | Dew Point |
How is it possible to make oxygen analysis?
In order to comply with obligations under the rules on oxygen medical equipment, manufacturers must provide its laboratory with set of tools that are configured to manage the entire operation using the measurement principles accepted. The company must collect the data and write the report’s analysis in an attempt to ensure complete traceability of all measurements and tests carried out over that of the containers of oxygen produced and sold in time. A process undoubtedly complicated, resulting in higher costs and a rapid decline in competitiveness. Yet the alternative exists. With advanced equipment, it is possible to automate some steps and drastically reduce the times.
Our company has developed OXYmed, a compact system with the utmost professionalism to manage the production of oxygen in containers. With OXYmed you can:
- • Manage up to 3 lines of separate analyzes connected to the storage tank as well as the oxygen product from the cylinders and from the tank;
- • Run automatically measures required in accordance with the measurement principles accepted by Pharmacopoeia
- • Manage automatically analyzes up to a maximum of 6 containers of cryogenic oxygen (set expansion needed);
- • Automatically generate reports in electronic format printing along with a special label to be affixed to the container analyzed
- • Store the measures in an internal database that can be shared with external systems or corporate network.
