State Food and Drug Administration's Although after the November 2006, the State Food and Drug Administration has issued a
a result, regulatory policy inconsistencies, no uniform standards for oxygen, resulting in the quality of molecular sieve oxygen and legitimacy,
nike shoes uk, as the industry's long and outstanding medical oxygen is a major drawback. Medical Oxygen markets exacerbated the confusion and unfair competition.
5 10 May, the Beijing First Intermediate People's Court accepted the 17 companies in Henan Province and the attorney on behalf of the indictment. This was seen as enterprise rights oxygen taken a historic step
David Liu
Not long ago, Children's Hospital of Chenzhou City, Hunan Province, with industrial oxygen for medical oxygen in the media of posing after has attracted extensive vibration.
may soon subside slightly in the incident, recently, there are Internet users post broke the news that many hospitals now grown by molecular sieve oxygen concentrator zone, the quality sometimes more than
5 10 May, Xiangtan University Law School professor and Peng Ou Oi Chao, Su Jing, Xie Zhonghua other 10 students to the State Council Legislative Affairs Office jointly sent an urgent application, request the State Council Legislative Affairs Office of the allow the hospital through the molecular sieve oxygen concentrator produces oxygen,
At the same time, May 10, representatives of 17 enterprises in Henan Province and attorney, to the Beijing First Intermediate People's Court to submit the indictment, prosecution of the State Food and Drug Administration, one day in the hospital acceptance of the indictment. In addition, the Hunan and northeast of the business representatives also in May 11 and before next week, were indicted SFDA submission of Hunan, Henan and Northeast China more than 40 companies will participate in the proceedings.
fact, the legality of the Molecular Sieve Oxygen has no clear legal provisions. Despite the March 15, Children's Hospital of Chenzhou, after the outbreak of industrial oxygen, the State Food and Drug Administration issued a molecular sieve oxygen generation equipment monitoring and supervision of industrial oxygen. However, the legality of molecular sieve oxygen, the State Food and Drug Administration has not yet specified.
illegal under the pretext of legitimacy production of oxygen
grown by molecular sieve oxygen concentrator oxygen. This lack of oxygen because of the quality standards, the quality sometimes more than 'industrial oxygen' quality is even worse ... ... quell the occasion of the emergence of the post, but also to calm the industry Zaixianbolan medical oxygen.
this production for
this post appeared immediately aroused strong public concern, Xiangtan University School of Law professor is one of a loving Europe.
to the Government's In recent years, he's quibbling, the Hunan provincial government revoked the clearance issued by government departments
in access to relevant information, Oi found in Europe, allowing users the hospital called molecular sieve oxygen generator produces oxygen through the Kusakabe issued
where Preparation of the method of oxygen administration to implement a drug approval number, but also temporarily issue a use of molecular sieve oxygen generator produces oxygen supply for use in patients put on legitimacy.
questioned red tape a letter to the State
So, this allows medical institutions to use molecular sieve oxygen generator produces oxygen,
European Oi from the State Food and Drug Administration official website to download this file immediately after the convening of its law students to They agreed that the introduction of this document has no legal basis, but also contrary to existing laws.
Europe loving the municipalities drug regulatory approval and issue a No
provisions of Article Five, medical preparations made by the clinical needs of the unit should be on the market does not supply the species, and subject to the provinces, autonomous regions and municipalities behind the drug regulatory approval can be prepared.
Europe loving the view that production of medical oxygen Changsha some hospitals, two premises are not valid: first, they do not have provincial Drug Administration, issued a regular medical oxygen supply manufacturers, not clinical needs of the units on the market does not supply the species.
quality standards, should be recognized as a
obligations.
said.
2010 年 5 10 May, 10 European professors and students loving a joint letter, request the State Council Legislative Affairs Office of the State Food and Drug Administration issued a review.
the impact of molecular sieve oxygen oxygen Enterprise
Zhou Mingchun Lianhu Medical Oxygen Plant Manager City of
According to report,
Homme de Sport Gucci, as the first medical oxygen production enterprises in Hunan Province, the plant currently facing the pressure of survival.
Zhou Mingchun told reporters, medical institutions, through the molecular sieve oxygen generator produces oxygen, very low cost, simple process,
louis vuitton, many medical institutions in the country is popular. Only the medical industry in Hunan Province oxygen market to account for at least 60% of the market.
So, there is a clear national legal provisions for this, why hospitals keen to commence oxygen project? Insiders, oxygen machine behind a huge economic interests.
. However, some hospitals that produce their own oxygen, low prices, they were unaware of this, so some large hospitals are not willing to buy a regular manufacturer of medical oxygen oxygen, turn their own production. so save trouble and money. told reporters.
Informed sources have disclosed to reporters, a molecular sieve oxygen from a few million to hundreds of thousand dollars because of low cost, simple process, since many large hospitals are willing to purchase from the molecular sieve oxygen concentrator producing oxygen, and sometimes the money to buy oxygen a year to get it back.
director of medical oxygen plant Lan Liu Guanghua this quite complaints.
the hospital staff told reporters, had not installed before the molecular sieve oxygen concentrator, the hospital every day to a local medical oxygen into more than 200 manufacturers of medical oxygen bottles, and last year the hospital installed its own After molecular sieve oxygen concentrator, medical oxygen purchased more than 200 bottles a month.
to know.
in the shock, many medical oxygen production companies are considering converting the other gases.
regulatory standards for medical oxygen unfair
It is understood, air separation and cryogenic molecular sieve pressure swing adsorption Medical Medical Oxygen Making of China's main method, the current This is a mandatory national standards.
for medical oxygen production enterprises, the State Medical Oxygen has a set of production quality control system, from technical staff to the production site configuration management, quality inspection from the prenatal and postnatal to the quality of after-sales tracking, are There are strict requirements. Medical Oxygen content of GMP certification is up to 12 major items, 198 sub-items (which contains 16 stars with a veto items).
However, medical institutions, medical molecular sieve pressure swing adsorption without specialized personnel and testing equipment, the quality of its management. Production of molecular sieve pressure swing adsorption and oxygen content can only reach 93%, with the 2005 edition of Chinese Pharmacopoeia far 99.5%, and even some not yet reached the industrial oxygen Chinese Pharmacopoeia standards.
management policy for this inconsistency led to unfair competition within the industry phenomenon, medical oxygen companies have been complaining.
The reporters also found that the pharmaceutical market for molecular sieve oxygen generator is the
Drug Administration, who declined to name the staff to the Require hospitals to enhance facilities management to ensure normal operation of its rigorous testing of oxygen output. However, the provisions of the legal framework of molecular sieve oxygen limited.
person calls, medical oxygen regulators should improve laws and regulations to safeguard the safety of the medical industry with oxygen.
Yongzhou Food and Drug Administration Lvguo Shan has written that, due to inconsistent regulatory policies, resulting in unfair competition within the industry, resulting in production of medical oxygen is no market for their products, enterprises can survive, is not conducive to medical the healthy development of the oxygen industry.
Lvguo Shan suggested that the state should be a clear legal aspects of the scope of medical oxygen, medical oxygen uniform national standard, which provides: Either the oxygen equipment, as long as medical oxygen should be included for the clinical areas, according to drug administration, the quality should comply with national standard; of medical institutions concentrated oxygen supply system into the administrative license management.
Lvguo Shan that only improve laws and regulations in order to fundamentally solve the oxygen for medical management intensity varies, the problem of unfair regulatory standards.
Lvguo Shan also proposed to set up an oxygen center? Suggested that the state qualified to operate a drug wholesale business as the basis, the establishment of oxygen in the center of a certain area, the implementation of unified procurement oxygen centers, unified distribution, from a fundamental solution to medical oxygen circulation problems.
■ Further Reading
present, medical institutions are medical oxygen, liquid oxygen and molecular sieve oxygen-third of the world.
medical oxygen, liquid oxygen production companies through the national SFDA GMP certification, drug registration card, pharmaceutical production license, the state as a medicine to management; and molecular sieve oxygen generator is the medical institutions themselves through molecular sieve oxygen equipment oxygen, not by the State Food and Drug Administration GMP certification, but also without the drug registration number and drug production licenses.
be pointed out that medical oxygen for approval by the Drug Administration Department, is the low temperature air separation Preparation of medical oxygen.
present the highest oxygen content of Molecular Sieve Oxygen 90% (ml / ml), but the use of molecular sieve oxygen generator hospitals oxygen content of 70% to 80% (ml / ml) (carbon dioxide, carbon monoxide, pH , gaseous oxides, were not tested).
according to state regulations, the hospital medical oxygen therapy for patients should be national standards for medical oxygen in accordance with GB8982 and the 2005 edition of / ml). Preparation of molecular sieve oxygen generator with the failure of oxygen directly to the clinical, hazardous to life and health of the patient. Especially when used in intensive rescue the patient can easily lead to suffocation and death.
hospitals choose to use molecular sieve oxygen, in addition to equipment installation to the hospital easy to use, the most important reason is the Molecular Sieve Oxygen can bring huge profits.
Insiders estimate calculated by Mei Pingzhuang 4 liters, medical oxygen bottle on the market price of 30 yuan, while the molecular sieve oxygen production cost per bottle is only 4 yuan, even with all the labor, maintenance However, such cost around 14 yuan.
oxygen for patients and hospitals is not based on flow rate calculated based on the calculation of time. At present the average charge of 5 yuan per hour, the hospital profits from the profit of 10 times.