Problems in clinical use of medical molecular sieves

1. Relevant guidance documents for the management of medical molecular sieve oxygen production

  Medical oxygen refers to the oxygen that is clinically used for the prevention and treatment of hypoxia. Its quality should meet the requirements of the Pharmacopoeia of the People's Republic of China (2010 Edition). According to the "Pharmaceutical Administration Law of the People's Republic of China" and other laws and regulations, "medical oxygen" belongs to the scope of drug management, and medical oxygen manufacturers implement drug production license management and implement the drug GMP certification system.

  Medical oxygen is widely used in clinics, and its quality is directly related to the life and health of patients. In order to further strengthen the supervision of medical oxygen, the State Food and Drug Administration has issued the "Letter on Soliciting Opinions on the Standards of Oxygen Concentrator Supply System for Medical Gas Piping Systems and the Clinical Application of Oxygen-enriched Air" (Food and Drug Administration Letter [2010] No. 564); "Notice on Strengthening the Supervision of Medical Oxygen" (National Food and Drug Administration Law [2010] No. 99); "Notice on Carrying out Special Inspection of Molecular Sieve Oxygen Making Equipment in Use in Medical Institutions" (National Food Yao Jian Xi [2010] No. 109); "Reply on Issues Concerning the Supervision and Administration of Oxygen and Nitrous Oxide Mixed Gases" (Guo Shi Yao Jian Zhu [2006] No. 586); "Reply on Issues Concerning the Supervision of Medical Oxygen Business Enterprises "(National Food and Drug Administration [2006] No. 440); "Response on Medical Oxygen Management Issues" (Shiyao Jian Zhuhan [2004] No. 107); "Notice on Medical Oxygen Management Issues" (National Food and Drug Administration Supervision Office [2003] No.144) and other related documents, along with the implementation of each document, will conduct special supervision and inspection on the use of medical oxygen by medical institutions to ensure the quality of medical oxygen and ensure the safety of patients using medical oxygen. The use of medical molecular sieve oxygen in medical institutions has gone from excessive use in the early days to a large decrease in recent years. Decision makers in medical institutions have realized that its clinical use will bring about many legal and industry management issues.

  2. Medical oxygen and oxygen quality standards produced by medical molecular sieve

  "The Pharmacopoeia of the People's Republic of China" (2010 edition two): Oxygen O2 32.00, this product contains and O2 not less than 99.5% (ml/ml). GB 8982-2009 "Medical and Aviation Respiratory Oxygen" Standard: Technical requirements for medical oxygen Oxygen (O2) content (volume fraction)/10-2≥99.5. The medical oxygen produced by the cryogenic air separation method must meet the requirement of oxygen content of 99.5% (volume fraction)/10-2 ≥99.5; the oxygen-enriched air produced by the medical molecular sieve pressure swing adsorption method is in accordance with YY/T0298-1998 "Medical molecular sieve oxygen production equipment "General Technical Specifications" standard: oxygen concentration is ≥90% (V/V). In the terminology of "Medical Gas Engineering Technical Specifications", the main component of medical oxygen (medical oxygen) is oxygen and limits the concentration of pollutants for the prevention and treatment of hypoxia. Its quality should meet the requirements of the national pharmacopoeia. Medical oxygen-enriched air is a concentrated oxygen-containing gas produced by separating nitrogen from ambient air through a medical molecular sieve (PSA) oxygen generator. The oxygen produced by the pressure swing adsorption method of medical molecular sieve cannot be called "medical oxygen".

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3. Problems in clinical use of medical molecular sieve to produce oxygen

  (1) The oxygen content produced by medical molecular sieve does not meet the national standards and national pharmacopoeias for medical oxygen

  "The People's Republic of China Pharmacopoeia" (2010 edition two) contains no less than 99.5% (ml/ml) of O2 for medical oxygen. GB 8982-2009 "Medical and Aviation Respiratory Oxygen" standard, medical oxygen technical requirements, oxygen (O2) content (volume fraction/10-2 ≥99.5, "Notice on Medical Oxygen Management Issues" (China Food and Drug Administration [ 2003] No. 144) The clinical guidance document for the application of medical molecular sieve pressure swing adsorption method to prepare oxygen. The technical basis is YY/T0298-1998 "General Technical Specifications for Medical Molecular Sieve Oxygen Making Equipment", the oxygen concentration is ≥90% (V /V). Since 2003, the National Pharmacopoeia has been revised several times, and its quality standards have not been supplemented so far.

  (2) Oxygen produced by medical molecular sieve is not included in the drug regulatory system

YY/T0298-1998 "General technical specifications for medical molecular sieve oxygen production equipment" clearly: This standard is applicable to medical molecular sieve production for medical and health care purposes, using zeolite molecular sieve as adsorbent and pressure swing adsorption (PSA) to produce medical oxygen. Oxygen equipment. The State Food and Drug Administration [2003] No. 144 document clearly does not include the drug regulatory system for the time being.

  4. Suggestions on strengthening the management of medical oxygen production from medical molecular sieve

  (1) Formulate national standards and regulations for the clinical application scope of medical molecular sieve for preparing medical oxygen-enriched air

According to the "Letter on Soliciting Opinions on the Standards of "Oxygen Concentrator Gas Supply System for Medical Gas Piping Systems" and the Clinical Application of Oxygen-enriched Air" (Food and Drug Administration Office Letter [2010] No. 564 Document Arrangement, State Food and Drug Administration The clinical application scope of oxygen-enriched air produced by the medical molecular sieve oxygen production equipment of the medical gas pipeline system has been solicited. Before the formal promulgation and implementation, it is recommended that medical institutions that do not meet the clinical application scope should formulate a rectification plan as soon as possible. Combined with medical molecular sieve oxygen source In the design and operation of the system, a liquid oxygen storage tank or a steel cylinder busbar system backup system is set up. Adjusting the oxygen supply system is the best way to deal with the implementation of the standard.

  (2) Medical oxygen-enriched air produced by medical molecular sieve is included in the scope of drug management when it is used clinically

Oxygen-enriched air is not medical oxygen. The State Food and Drug Administration [2003] No. 144 mentioned that "the oxygen produced by this method will not be subject to drug approval number management, and the "medical institution preparation license" will not be issued temporarily. . According to the "Pharmaceutical Law of the People's Republic of China" and the "Implementation Regulations of the Drug Administration Law of the People's Republic of China", when medical molecular sieve is used to produce oxygen-enriched air for clinical use, medical institutions should apply for the "Medical Institution Preparation License" in accordance with the regulations of medical institution pharmaceutical management .

  (3) When medical institutions choose medical molecular sieve to produce oxygen-enriched air, they should conduct legal, economic and safety analysis

  Article 32 of the Drug Administration Law of the People's Republic of China, the Pharmacopoeia of the People's Republic of China and the drug standards promulgated by the drug regulatory department of the State Council are the national drug standards. According to a 21st Century Business Online report, on May 10, 2010, "More than 40 medical oxygen companies sued the State Food and Drug Administration for administrative inaction". These companies believed that medical institutions at all levels produced "no license, no certification, and no products Molecular sieve oxygen, a product of "registered and non-inspected", is currently used in major hospitals. The State Food and Drug Administration as a supervisor has a lack of supervision and should be sued for its administrative inaction. On the one hand, the State Food and Drug Administration requires us to produce medical oxygen in accordance with standards, and on the other hand, it allows the existence of oxygen produced by hospital molecular sieve, which leads to unfair competition. The "poison capsule" incident that the country is managing once again reminds us of the importance of the Pharmacopoeia of the People's Republic of China as an authoritative standard for medicines.

  The three oxygen supply modes of oxygen cylinder bus bar, liquid oxygen storage tank, and medical molecular sieve oxygen generator carry out simple economic safety analysis.

The author once used liquid oxygen storage tanks (two sets of 5m3, one standby and one use) in Peking University Third Hospital before 2005. In September 2005 and October 2006, they were replaced with four sets of 20m3/h and three sets of 20m3/h. For the pressure swing adsorption oxygen generator, the operating cost analysis is carried out without considering the labor management cost. Under normal use, the annual operating cost of the pressure swing adsorption oxygen generator is: 1671416 yuan; the oxygen generator room is occupied The building area of indoor space is 300m2; 14 persons on duty are required. The annual operating cost of the oxygen supply mode of the liquid oxygen storage tank is 811,220 yuan; the liquid oxygen storage tank occupies an outdoor space of 60m2; 5 persons on duty are required. Through economic analysis, it can be concluded that the comprehensive cost of using pressure swing adsorption medical molecular oxygen generator is twice that of traditional liquid oxygen storage tank oxygen supply system without calculating labor cost under the condition that medical institutions of the same scale use oxygen.

  5. Conclusion

It is believed that the management of oxygen-enriched air produced by medical molecular sieves will become increasingly strict. Medical institutions that have used molecular sieves to produce oxygen should take an objective view of the country’s current over-regulation policy. In order to ensure the safety, economy and legality of oxygen use by medical institutions, medical institutions should be strengthened. The supervision of molecular sieve production of oxygen-enriched air in clinical use is urgent.