"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."