"Molecular sieve oxygen" Why questioned

Government Response

 Just equipment regardless of the product will change the status quo

 Faced with all walks of life to 93% oxygen questioned, the State Food and Drug Administration official told reporters that the presence of molecular sieve oxygen in the hospital as the country does have a file support.  As the regulatory authorities to do now is to strengthen supervision and standardize use.

 It is reported that the State Food and Drug Administration had 2003 Nianxia issued "on the management of medical oxygen notice."  Which provides that "medical molecular sieve pressure swing adsorption oxygen Preparation, its quality standards are being developed by the organization in the State Pharmacopoeia Commission, before the implementation of the standards promulgated, oxygen temporarily implementation of the method of preparation of drug approval number, also temporarily does not issue a "medical preparations license." But molecular sieve oxygen equipment must obtain "medical device registration permit", and must comply with YY / T0289-1998 ("molecular sieve oxygen medical equipment general technical specifications") requirements, the Provincial Food and Drug Administration for clinical use behind the record. " activated zeolite powders

 "But the key is so long, but it has not issued the relevant standards." The official said.

 Reporters interviewed the State Food and Drug Administration Medical Device Supervision Division Wangbao Ting.  Wangbao Ting said that previously did for medical supervision only to the molecular sieve oxygen equipment, and without regard to the product itself.  "But this situation will soon change."

王宝亭 demonstrate to reporters in the hands of a thick stack of material, said: "At present, China is being transformed ISO100832006" medical gas pipeline systems with an oxygen concentrator supply systems, "the pharmaceutical industry to international standards, my hand is submitted for approval items . "

 He said that after the approval of the implementation of this standard, the original equipment regardless of the status quo simply will change products, including products, including the entire system will be managed.

 As for the 93% oxygen "identity" issue, Wangbao Ting said regulators are considering now to 93% oxygen included in the "Chinese Pharmacopoeia" management, "but it will take some time."

王宝亭 said that the current regulators are stepping molecular sieve oxygen hospital with the supervision and inspection.  The first thorough investigation of medical institutions for medical molecular sieve oxygen equipment have not registered a license; the second is to maintain the use of molecular sieve oxygen equipment for medical check compliance with relevant regulations and standards; c is the concentration of oxygen in the molecular sieve oxygen equipment testing to production eligibility.  At present, the State Food and Drug Administration's six inspection teams were in the country are 18 provinces (autonomous regions and municipalities) to carry out supervision.

 News from the National Adverse Drug Reaction Monitoring Center also showed that after several expert meetings, the regulatory authorities are considering "further clarify the 93% oxygen for medical molecular sieve oxygen equipment prepared in the scope of clinical."

"Molecular sieve oxygen" Why questioned

99.5% of the data from the "Chinese Pharmacopoeia" provisions of the standard medical oxygen content of not less than 99.5 percent oxygen, a state compulsory standards.  The 90% figure is derived from the "medical molecular sieve oxygen equipment General technical specifications" (YY / T0289-1998) requirements.

 Skeptics claim that the same medical oxygen, why there are two different content standards?  A national mandatory standards, a technical standards, no doubt to the national mandatory standards should prevail.

 The "Identity treatment" of two different medical oxygen products, a raise questions of another reason.

 According to regulations, air separation production of low molecular weight Medical Oxygen implement drug approval number.  That is, if you want to produce medical oxygen, first to obtain Drug Administration drug production licenses issued by the department.

 A medical oxygen production business manager, said the company needs to produce medical oxygen drug GMP certification.  GMP certified medical oxygen content of up to 12 major items, 198 sub-items.

 The production of medical molecular sieve oxygen medical oxygen present there is no clear position.

 According to the State Food and Drug Administration related departments, the current medical molecular sieve oxygen equipment is included in the second category of medical equipment management, installation of equipment require approval and registration at the provincial level food and drug regulatory authorities.  "But for the use of medical oxygen products produced in this way, without a clear definition, neither the inclusion Drug Administration, also not included in the hospital preparation for management." The official said.

 Expert opinion

 As long as the standard operation, molecular sieve oxygen is safe

 93% oxygen incurred questioned why there is a reason to worry about the safety of this product.

 A medical oxygen production company CEOs, told reporters that medical oxygen production enterprises Medical Oxygen has a strict quality management system, while in the hospital just a few trained personnel to be responsible, in the absence of strict management standards, whether ensure the quality of the product?

 The official said that, in accordance with the requirements of enterprises for raw materials, medical oxygen - air, with strict quality requirements.  General requirements for Medical Oxygen enterprise built on the air, and the molecular sieve oxygen hospitals are required to make the best of the air, due to geographical location, special environment in which air quality is difficult to be guaranteed.

 93% oxygen for bad security, the National Drug Reaction Monitoring Center has held a forum of experts and demonstration.  Most recently in early July this year.

 Experts are more consistent view is that the current preparation of medical molecular sieve oxygen concentrator technology is a mature technology, as long as the standard operation, the molecular sieve oxygen safety is guaranteed.

 Participants of medical equipment management and clinical experts believe that the clinical use of oxygen generally use a lower concentration of oxygen (50% less), only the anesthesia, ICU (intensive care unit) may have different uses and oxygen concentration, so 93 % oxygen fully able to meet clinical needs.

 National Adverse Drug Reaction 5a zeolite molecular sieves Monitoring Center statistics show that from 2003 to 2009, the Center medical device adverse event database does not receive the 93% oxygen suspicious about the medical device adverse event reports.

 Statistics from the hospital showed, Beijing Armed Police General Hospital, Air Force General Hospital, Peking University First Hospital, Peking University Third Hospital, Beijing Tongren Hospital and other hospitals using molecular sieve equipment, has accumulated hundreds of thousands or even millions of Use Cases , did not show medical malpractice.

 But experts also suggested that the current 93% in our clinical use of oxygen should be clear, not general use.

 According to experts, the current in different countries for 93% oxygen international management measures vary, but generally have a limited range of use.  In the United States, 93 percent oxygen is included in the Pharmacopoeia for management, but must be explicitly specified hospital patients which used an oxygen; in Canada, 93% of oxygen is also approved for use in clinical practice, but only in the medical institutions in remote areas; in EU, 93% oxygen also been approved for clinical use, but has a more detailed provisions.

 One expert believes the PLA General Hospital, 13x zeolite molecular sieves first aid and oxygen hyperbaric chamber, oxygen concentration, the higher the better, and the low molecular sieve oxygen concentration, and therefore should be banned aid and hyperbaric oxygen 93% oxygen.

PSA nitrogen plant design basis

   Adsorption matrix for all types of adsorbents, such as: aluminum plastic, silicone, 3a zeolite molecular sieves activated carbon and molecular sieves.  Among PSA nitrogen means they use various types of molecular sieve adsorbents (zeolites, carbon molecular sieves), various types of molecular sieves have specific selective adsorption, such as nitrogen is often used 3A carbon molecular sieve oxygen, and adsorption H20, C02 multi-use 13X zeolites.  PSA Nitrogen Generator works: clean pressurized air (oxygen and nitrogen mixed gas) through some sort of carbon molecular sieve, most of the remaining traces of oxygen and water is a molecular sieve adsorption, adsorption of nitrogen is unable to be discharged This nitrogen adsorption stage.   While reducing the pressure to atmospheric or subatmospheric pressure, the adsorption capacity of the molecular sieve oxygen decreased oxygen which is resolved in a compressed state of the adsorbed water and the regeneration is parsed (oxygen) phase.  Molecular sieves can be parsed and nitrogen adsorption phase of the next cycle, the cycle is repeated to obtain a certain purity of nitrogen, while some of the purity of the oxygen enriched air. 

Hospital inspection identified three focus on molecular sieve oxygen

Health News (Reporter Wang Lemin) July 25, the State Food and Drug Administration held a national medical molecular sieve oxygen equipment special inspection group working conference in Beijing. The meeting identified the key elements of this inspection work. State Food and Drug Administration Medical Device Division Wangbao Ting said the focus of the inspection focused on three aspects: First, check the medical institutions for medical activated zeolite molecular sieve oxygen equipment have not registered a license, the second is to check the medical molecular sieve system maintenance of oxygen equipment, the use of compliance with relevant regulations and standards, is sampling and testing equipment produced three oxygen concentration is qualified. April this year, the State Food and Drug Administraactivated zeolite sieve oxygen equipment. After the meeting, six inspection teams to Beijing, Jiangsu, Zhejiang, Shandong and other 18 provinces (autonomous regions and municipalities) to carry out a 10-day inspection.

tion launched a medical institution medical molecular sieve oxygen equipment special inspection. Medical institutions around the self, food and drug regulatory departments of medical institutions were random. The previous phase of this inspection is intended to further promote special inspection work to further standardize and improve the safety level of protection of medical

Structure

Thus proteoglycan aggregates composed of coiled turns, forming a sieve-like microporous structure, called molecular sieves. Zeolite molecular sieve allowing only its micro-pores is less than the material molecular sieve separation through its pores large macromolecules, the bacteria has a barrier function. The matrix becomes the limiting diffusion of bacteria and other harmful substances defensive barrier. Hemolytic streptococcus and cancer cells can produce hyaluronidase, decomposition proteoglycan matrix structure damage, to be spread. The proteoglycan aggregates molecular sieve adsorbent further combined with a plurality of hydrophilic groups capable of binding to a large number of water molecules, forming extracellular "reservoirs."

zeolite molecular sieves

Zeolite adsorption has two characteristics: (1) the center of the polarity on the surface of a Lewis strong; (2) the zeolite cages or channels in small size, which makes the strong molecular sieve siliporite gravitational field. Therefore, the adsorption capacity of the adsorbate molecules is much more than other types of adsorbent. Even adsorbate partial pressure (or concentration) is low, the adsorption capacity is still considerable. Zeolite adsorption separation not only the size and shape of 4a zeolite powder the adsorbate molecules, but also on its polarity, and therefore, the zeolite molecular sieves can also be used to separate substances of similar size.