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.
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