​The peak of wave 4 of the COVID-19 pandemic meant not only a crisis of ICU beds and drugs, but also of medical oxygen, administered to patients in serious condition.At the beginning of November, the problem was recognized even by the authorities, through the voice of Prime Minister Florin Cîțu and the head of the Department for Emergency Situations, Raed Arafat, who also organized a meeting with the companies that deliver oxygen.The solution found by the authorities at that time, the use of "technical" oxygen - in fact oxygen with a concentration of 90-96%, produced in oxygen concentrators - strictly in situations where medical oxygen (minimum concentration of 99.5%) is not available, it is a back and forth: contested by many doctors and, according to an official response from the National Medicines Agency to HotNews.ro, outside the legal conditions to be approved as a medicine for human use.Is lower concentration oxygen a solution for patients or not?Doctors consulted by HotNews.ro say that it is considered for medical use and used especially at home, by patients with severe chronic respiratory failure, being produced on site, with the help of oxygen concentrators.In the case of COVID-19 patients in critical condition and, in general, in the critical patient area (ATI) it is not recommended by doctors, and some of them refuse to use it, for these patients oxygen with maximum concentration - 99 is required, 5% - 100%.In addition, oxygen with 99.5% - 100% concentration is the only one authorized by the National Medicines Agency as a medicine for human use, according to a response from the institution, provided at the request of HotNews.ro.At the beginning of November, faced with the oxygen crisis in the context of the wave of COVID-19 patients in serious condition, the authorities, led by Prime Minister Florin Cîțu and the head of the Department for Emergency Situations, Raed Arafat, organized a meeting on this topic, at which included representatives of the companies that deliver oxygen in Romania."We have identified several solutions to solve the oxygen crisis in hospitals. Following discussions with oxygen producers and DSU representatives, we have determined that the best measure is the possibility of using industrial oxygen for COVID patients," announced Florin Cîțu at the time, in a message published on the Government's Facebook page.The head of DSU, Raed Arafat, also admitted that Romania is facing an oxygen crisis, explaining that "there are only two large companies and one smaller one that deliver oxygen in the country".Raed Arafat then stated that a solution, where medical oxygen is not available, is to use technical oxygen, which has a lower concentration of 93% instead of 99%.At that time, a circular was also issued by which the defendants were instructed to use the technical oxygen option, in the situation where they ran out of medical oxygen.There are two types of oxygen used for patients:1. Medicinal oxygen O99.5%, with a concentration of at least 99.5% v/v, resulting from a specialized industrial process.It is the only type of oxygen authorized by the National Medicines Agency to be placed on the market as a medicine for human use.The National Agency for Medicines specifies, in its response to HotNews.ro, that it authorizes medicinal gases to be placed on the market as medicines for human use, i.e. the medicinal product Medicinal Oxygen O99.5%, which has a concentration of at least 99.5% v/v , which results from a specialized industrial process, carried out in accordance with the "Principles and guidelines of good manufacturing practice for medicinal products for human use, including for clinical investigations", approved by Order of the Minister of Public Health no.905/2006 and with the basic requirements of the Good Manufacturing Practice Guide, approved by the Decision of the Scientific Council of ANMDMR no.5/2012 (Annex 6 "Manufacturing medicinal gases").The therapeutic indications of the medicinal Oxygen O99.5% are approved by ANMDMR and appear in the prospectus and the Summary of Product Characteristics, attached to the marketing authorization, the Medicines Agency also states.2. Medical oxygen O93, with a concentration of 90 - 96% oxygen - the oxygen that both Prime Minister Florin Cîțu and the head of DSU, Raed Arafat, spoke of as "technical oxygen".It is obtained through an in-situ (on-site) method, with the help of oxygen concentrators, these being installations that fall into the category of medical devices regulated by Government Decision no.54/2009 on medical devices.To be placed on the market, the manufacturer of the medical device must carry out a conformity assessment procedure applicable to the risk class, involving a notified body, issue a declaration of conformity and apply the CE marking followed by the identification number of the notified body.Both from a qualitative and institutional - procedural point of view, the product Medical Oxygen O93 does not meet the legal conditions to be approved as a medicine for human use.Medical devices are subject to the conformity assessment procedure by the manufacturer, together with a notified body in the specific field, says the National Medicines Agency, in the answer provided by HotNews.ro.Practically, according to the National Medicines Agency, in the case of this type of oxygen, only the material support is certified - the medical oxygen concentrator device - and not the effect of its activity - the O93 medical oxygen product, according to art.933 of Law 95/2006 on health reform, users have the obligation to ensure the maintenance and repair of these medical devices, with units approved by ANMDMR, based on the Order of the Minister of Health no.566/2020 for the approval of the Methodological Norms for the application of title XX of Law no.95/2006 regarding health reform, regarding the approval of activities in the field of medical devices.The Commission of the European Pharmacopoeia adopted, during 2010, a working document that establishes a standard for the quality control of the O93 Medical Oxygen product (Monograph 2.455 adopted in April 2010 and which describes the tests to be performed by the manufacturer of the installation and respectively by the users of the product), in order to harmonize the testing of this product throughout the European Union.As stated in the note in the preamble of this monograph, the O93 Medical Oxygen product does not have to have a marketing authorization and the good manufacturing practice guide does not apply to it.The inclusion of this product in the European Pharmacopoeia is not likely to establish an exception from the general regulatory regime of authorization procedures for the marketing of medicines for human use, states the National Medicines Agency.The European Pharmacopoeia provides two distinct oxygen monographs: Oxygen (0417) and Oxygen (93 percent) (2455).According to the Oxygen monograph (93 percent), it is produced in concentrators through a single-stage absorption purification of ambient air using zeolites, being a continuous process of generation at the point of use.The monograph also mentions that during production, the oxygen content is continuously monitored using a paramagnetic analyzer, and after the design and installation of the concentrator and after any significant modification or intervention to it, the quality of the produced gas must be controlled (in accordance with the Oxygen monograph (93 per cent) (2455).Regarding its storage (preservation), the monograph explicitly states that it is normally used in the place where it is produced, a supply system (medicinal gas pipeline) being required.On the other hand, the Commission of the European Pharmacopoeia has no attributions and does not draw up the nomenclature of medicines and does not have the capacity of regulatory authority in the field of medicine.It should be noted that the European Pharmacopoeia also contains monographs for other substances, including gases (e.g. nitrogen, compressed air) that are not medicines and do not have marketing authorizations.The conclusion of the National Medicines Agency: "we consider that the use of Oxigen 93% can only be done according to the decision of the ATI doctor and the medical protocols."Elena Copaciu, primary Anesthesiology-Intensive Therapy doctor at the Matei Balș Institute of Infectious Diseases and former head of the Anesthesia-Intensive Therapy Department of the Emergency University Hospital in Bucharest, confirms that, for hospitals, we are talking about two types of oxygen: 99%-100% purity and a second type, 93%, which is also for medical use, but we know you can't get more than 93% concentration."Both are for medical use, but in the critical patient area you need oxygen of 99.5%-100% purity. For some patients, the 93% purity is insufficient," explains Dr. Elena Copaciu for HotNews.ro.A third type is technical (industrial) oxygen, used in welding, which, says Elena Copaciu, "from my point of view, is out of the question for use in hospitals and its administration to patients".Elena Copaciu adds that, more than likely, the authorities who spoke on this topic made a confusion between the 93% oxygen and the one used in industry, which is not the problem of being used in hospitals.Florin Roșu, ATI primary physician and the manager of the Hospital for Infectious Diseases in Iași, tells HotNews.ro that he wanted in his hospital to treat patients only with oxygen of 99.5% purity, medicinal oxygen, and he administered only oxygen of 99.5%."I specifically announced ahead of time, so that there would be no interruption and I could only administer medical oxygen, 99.5% to the patients. I also had the hospital's strategic reserve, which I still have, because risk management learn that it is imperative to have a strategic reserve", explained doctor Florin Roșu.He also says that so far he has not had to administer anything else "and I don't want that either. I brought storage tanks, I always make sure I have oxygen"."It seems normal to me, patients have the right to receive medical oxygen", is the conclusion of doctor Florin Roșu.Warning: The author of the comment will be solely responsible for the content of the article and will assume any damages, in case of legal actions against those published.By pressing the "Send comment" button, you agree to the "Terms and conditions of use of the HotNews.ro website".If you do not agree, press the "Cancel" button.The HotNews.ro website uses cookies.Cookies help us improve our services.More details, here.You can change your cookie settings here: Change SettingsAlso read the Privacy Policy hereBy using HotNews.ro, you agree to our website's terms and conditions of use.