Approval of medical molecular sieve oxygen production equipment will be tightened
The introduction and use of medical molecular sieve oxygen production (molecular sieve pressure swing adsorption method) equipment will face increasingly strict regulatory and approval thresholds in the future.
"Medicine Economic News" reporter learned from the State Food and Drug Administration (SFDA), in order to further strengthen the medical oxygen supervision work, SFDA will organize supervision and inspection of medical oxygen supervision work of various provinces, autonomous regions and municipalities. To this end, SFDA recently issued a "Notice on Strengthening the Supervision of Medical Oxygen", requiring local food and drug regulatory authorities to effectively strengthen the use of medical molecular sieve oxygen production equipment supervision. According to the deployment of SFDA, molecular sieve oxygen production equipment of the oxygen source of the medical system's centralized oxygen supply system will be subject to special inspections. If the device standard is not met, the user unit shall be immediately ordered to stop using it and deal with it according to law. The notice also requires strict examination and approval of medical molecular sieve oxygen production equipment to ensure that approved products comply with laws and regulations.
With the increasing proportion of medical institutions using medical molecular sieve oxygen generation equipment as the oxygen source of the centralized oxygen supply system, the situation that medical institutions make oxygen themselves is still outside the norms, and now it may or may not supervise the medical molecular sieve oxygen production equipment. This gap is beginning to show up.
Medical oxygen disorder
In recent years, illegal acts of using industrial oxygen to pretend to be medical oxygen have been frequently exposed. "Actually, the behavior that some medical institutions use industrial oxygen to pretend to be medical oxygen is not only driven by interests, but also the problem of inconsistent norms and standards." A medical oxygen manufacturer who asked not to be named told reporters that medical oxygen At present, it is mainly divided into two "dosage forms" of liquid oxygen and gaseous oxygen. The GMP certification of related production enterprises has been going through for many years, and all of them must have a product approval number. It is required that gaseous oxygen packaging enterprises must be produced from certified liquid oxygen. Enterprises enter liquid oxygen and then repack, but there is no mandatory requirement that gaseous oxygen repacking companies supplied by liquid oxygen production enterprises must also pass relevant regulations for certification.
The manufacturer believes that medical oxygen supply should be standardized management of mutual certification, however, the current liquid oxygen production enterprises directly supply liquid oxygen to the hospital, after the hospital gasification, and then directly through the ward for patients to use, but in the hospital gasification section The process requires neither a permit nor a certification, and is in a regulatory gap, which leaves a "vacancy" for industrial oxygen to pretend to be medical oxygen.
In addition, although the molecular sieve oxygen production equipment is required to obtain the "Medical Device Registration License" and comply with the "General Technical Specification for Medical Molecular Sieve Oxygenation (Oxygen) Equipment", the quality of oxygen prepared by the molecular sieve pressure swing adsorption method has not yet been formulated. The administration of drug approval numbers is not implemented, so this unstandardized standard also breeds "puff oxygenation."
The industry looks forward to advancing with the times
With the new medical reform focusing on rural and community medical service systems, the demand for basic medical devices will become more obvious. The SFDA's special inspection of medical oxygen monitoring and molecular sieve oxygen production equipment around the country shows that the standardized management of medical oxygen equipment, which is widely used in clinical practice, will enter the stage of industrial reorganization.
It is understood that there are basically five modes of medical oxygen production process in China at present: 1. Low temperature air separation equipment → liquid oxygen → liquid oxygen pump → vaporizer → inflatable exhaust → medical oxygen gas cylinder (medical oxygen production enterprise); 2. low temperature system Oxygen machine (internal compression) → high pressure and normal temperature gaseous oxygen → inflatable row → medical oxygen gas cylinder (medical oxygen production enterprise); 3. Liquid oxygen → liquid oxygen storage tank → liquid oxygen pump → vaporizer → inflatable row → medical oxygen gas cylinder ( Medical oxygen filling enterprise); 4. Liquid oxygen → liquid oxygen storage tank → liquid oxygen pump → vaporizer → hospital centralized oxygen supply system; 5. Molecular sieve PSA pressure swing adsorption → hospital centralized oxygen supply system.
Among them, the first, second, and third types are all medical oxygen prepared by the low temperature air separation method. According to the drug management, the "pharmaceutical production license" management, product approval management and GMP compulsory certification system are implemented for the production enterprises; A method for producing oxygen for medical institutions, which is used for centralized oxygen supply in hospitals. The target of the SFDA's request to strengthen supervision is the fifth kind. The oxygen produced by the molecular sieve pressure swing adsorption method has not been managed according to drugs, and the circulation and use of its oxygen-making equipment are only on record. As medical institutions adopt this method to produce clinical oxygen, there is a spreading trend. For the need to strictly follow the current domestic legal standards for clinical medical oxygen-GB8982 "Medical Oxygen" and the 2005 edition of "Chinese Pharmacopoeia" (hereinafter referred to as "" Pharmacopoeia")) has been complaining about the inconsistent management policies leading to unfair competition in the industry.
At present, the low temperature air separation method and the medical molecular sieve pressure swing adsorption method are the main methods for the preparation of medical oxygen in my country. The current "Pharmacopoeia" sets the concentration of medical oxygen to ≥99.5%, which is a mandatory national standard. Some industry experts pointed out that it is very important to standardize the use scope of medical molecular sieve oxygen production equipment. Because if the purity and concentration of oxygen cannot reach the prescribed standard, it will have a great influence on the precision of some precision instruments such as ventilators and anesthesia machines, and it is easy to cause damage to the instruments. These precision instruments require the use of higher purity medical oxygen, and The higher the purity, the better. It is understood that the medical oxygen concentration obtained by the low temperature air separation method is greater than 99.5%, and the purity of molecular sieve oxygen production is basically between 90% and 96%.
For medical oxygen production enterprises, the state has a complete quality monitoring system for the production of medical oxygen, from the technical staff configuration to production site management, from pre- and post-production quality inspection to after-sale quality tracking, there are strict regulations. The certification content of medical oxygen GMP is as many as 12 large items and 198 sub-items (of which 16 items with stars are rejected by one vote). However, medical institutions do not have special personnel and testing equipment for quality management, and the oxygen content produced by the molecular sieve pressure swing adsorption method can only reach 93%, which is far from the 99.5% specified in the 2005 Pharmacopoeia, and even some It has not yet reached the industrial oxygen standard specified in the Pharmacopoeia.
A person from the Hunan Provincial Drug Supervision Department suggested that the national standard for medical oxygen should be unified as soon as possible. The quality of oxygen produced by any equipment should comply with the standard, and the centralized oxygen supply center of medical institutions should be included in the administrative license management. Solve the problem of different management efforts and unfair regulatory standards.
"The quality of medical gas systems called life support systems is not only related to the overall hospital construction level. It is also related to the life safety of patients. Therefore, national standards on medical gas engineering technology requirements are indispensable, and national standards "Advancing with the times" is also very necessary." Wang Yuhong, editor-in-chief of "Technical Specifications for Medical Gas Engineering" and senior engineer of Shanghai Modern Design Group, said.