The shortage of raw materials has led to a tight supply of end products from human serum albumin, intravenous gamma to various clotting factors, which has affected the medical needs of patients for medical treatment. For the current situation of China's blood products industry, relevant aspects should be attention
"China's blood products industry has gradually developed from the six major organisms of the Ministry of Health since the founding of the People's Republic of China. In the middle, there are foreign capital, * and local and private capital. The production technology has experienced raw materials from the placenta, The whole blood is separated into the stage of single mining. In response to the WHO call for “blood products should be self-sufficientâ€, in the past 20 years, China’s blood products industry has developed and expanded greatly, forming more than 30 enterprises. With an initial and loose industrial system with an annual output value of about 8 billion yuan (including vaccines), there are more than 10 mature varieties (plus more than 20 kinds of vaccines), which meet the treatment needs of clinical diseases in China. China's blood products industry has made a qualitative leap from raw material collection and production facilities, process level, quality control, and product efficacy. Some varieties are close to the international level, and the safety and effectiveness of products have been guaranteed.
However, we must also see that compared with developed countries, China's blood products industry still has shortcomings such as shortage of raw materials, poor comprehensive utilization of resources, hidden dangers of safety, and lagging certification standards, especially in the procurement of pulp standards and slurry feeders. There are still some gaps in management, quality control standards, technical processes, independent innovation, new product development, and internal quality and industry concepts of end products. In this regard, the author makes an in-depth discussion on the status quo and prospects of the plasma industry and the management and remediation of the slurry workers. â€
China's rectification and treatment of the raw material plasma market has achieved remarkable results over the years, ensuring the safety of upstream raw materials. From a comparative perspective, the system and management of the blood products industry, the strengthening of laws and regulations, the enforcement measures, and the safety of products are all in a good period and stage of history. It is effective in rectifying and strengthening supervision of raw material plasma and upstream markets. In order to ensure the safe application of blood products and eradicate hidden dangers in safety management, China's relevant functional departments have jointly reorganized the blood products industry. Especially since 1998-2007, China has carried out several treatments on the pulp industry, which is powerful. It has cracked down on illegal blood collection and supply, further safeguarded the safety of upstream raw material blood, shut down nearly 40 non-standard single-paste stations, and banned GMP certificates for three companies, further standardizing the supply of pulpers and pulp stations. Management avoids personal injury and medical and social problems caused by product safety incidents in Western countries. However, while the industry is regulating and developing, it also has some new problems that deserve our deep reflection.
Industry status
At present, the amount of pulp collected by domestic blood products manufacturers has dropped sharply, from about 4,960 tons in the historical peak to about 2,700 tons in 2007; almost every company's production capacity has dropped by 35% to 50%; and domestic blood products are in short supply. The phenomenon has not seen a trend of fundamental warming or easing. It is difficult for people to use drugs and hospitals for normal surgery and emergency rescue drugs, especially in some second-tier cities. The normal medical order is disturbed and affected, and even the unfortunate incident of hemophilia patients death due to drug-free treatment. Looking at the pulping situation in 2008, this situation does not necessarily show signs of a turnaround.
China is a big country with a population of 1.3 billion. It should have a rich plasma base and resources, and blood products should not be scarce. Compared with the United States, which has a population of more than 300 million people, its management of the pulp industry is orderly. The team of pulpers is bigger and more orderly than ours. The amount of pulp is 3 to 4 times that of China, and the production capacity and variety are abundant and very Abundant. Not only do we meet the needs ourselves, but there are also a large number of products exported to foreign countries. This phenomenon is worthy of our in-depth study.
At present, due to the reduction of the supply of pulp, the hospital terminal has a comprehensive tightening of blood products such as human serum albumin, intravenous gamma to various coagulation factors, and the medical needs and market supply gaps are large, which has caused the decision-making level and the competent authorities. Value and attention. It should be said that in recent years, the state has introduced a series of management policies to effectively rectify the market. However, some of the problems that have followed have gradually emerged: market blood products are tight and the goods are inhabited, major surgery and difficult surgery and rescue drugs. Difficult to find, the normal medical order of some hospitals is affected, and the national war preparation needs are insufficient.
Response plan
At present, the industry's original intention and desire for the management of pulp stations and slurry workers is good, but the new problems brought about are also severe. The author believes that the blood products industry should comprehensively analyze the crux of the problem from macro to micro. With reference to the experience, historical trajectory, nodes and operational norms of developed countries, it is necessary to have long-term and comprehensive solutions and guidelines, and then formulate scientific and comprehensive. Improve governance measures in stages to form a holistic and comprehensive strategic layout and program details:
First, in the principle of rectification, we must go online, but we must also provide flexible counseling in specific inspections. Second, while attaching importance to typical and prominent events, we should not focus on the details, the grass and the soldiers, and the strictness (strict, whole, stop, Third, in the strict supervision, it is necessary to assist with new rules, new policy guidelines and follow-up guidance; Fourth, while paying attention to indicators and paying attention to responsibility, we must also respect scientific laws and international operating standards; While measures are frequently strengthened and strengthened, countermeasures and remedial measures should be formulated in response to social problems, sequelae and market shortages. In this way, the process of comprehensive rectification of the plasma industry in China can be accelerated, regulations and rules are more comprehensive, quality control and The standard further jumped to form a continuous and long-lasting mechanism, regulatory order and industrial environment. While safeguarding domestic medical and national war preparation needs, it also narrowed the gap with advanced countries in cognitive concepts, quality standards and certification systems. China's blood products industry has become bigger and stronger, making it the driving force and driving engine for the development of China's biological products.
Industry misunderstanding
Due to the shortage of blood products, some misunderstandings of conflicts and understandings have emerged in public opinion, the media and other industries:
Misunderstanding 1 Manufacturers hoarding, pushing up prices
First of all, there is a general argument in the media and public opinion in the society that the lack of supply of products is the result of hoarding of manufacturers. In fact, in 2007, the amount of pulp in China fell from about 4,960 tons in the peak of 2003 to about 2,700 tons in 2007. In addition to the conversion of pulp stations and GMP reform, the pulp consumption of each factory is 35% to 50%. The decline in production, production shortages lead to a reduction in products, especially clotting factor products. Now the state has supervised the high-risk industry for blood products, and the number of units in each batch of manufactured products has been accurately determined by the batch issuance system. Coupled with the spot checks of the resident supervisors, the products are included in the control of the supervision network, plus It is almost impossible for manufacturers to hoard the inspections of the national drug supervision system.
Misunderstanding 2
There is also a public opinion that it is not going to be a mess if it is strictly controlled. This is true to some extent. This phenomenon has a deep national background and historical origins: any remediation is a responsibility, a phased task, but often lacks a comprehensive view and long-term planning, not in one step, to develop a long-term mechanism and thorough The solution requires a sense of decision-making and a strategic vision. Strict supervision is correct, but there should be corresponding measures and remedial measures for the current contradiction and social problems derived from this, which should also be part of comprehensive governance measures.
Misunderstanding 3 The management of the pulp station is a matter of the enterprise, and the functional agency is only responsible for inspection and remediation.
After the conversion of the pulp station, it is indeed the internal management of the enterprise, but the pulp station or the pulping company is also implemented in accordance with the GMP management regulations. How long does it take to guarantee the authority and rigor of the current standard? How long will it take to make changes? And improvement? Why are our specifications and SOPs (Standard Operating Procedures) in the process of repeated revision and improvement? If there are authoritative standards that can be used for reference, can we refer to and absorb acceptance?
How to manage the pulp station and how to manage the pulp company is definitely the responsibility of the company. However, as an “athlete†(enterprise), the process of adaptation needs to be adapted under repeated revision rules. At the same time, it is involved in the specific operation, “ Whether the referee is fully engaged and rationally coordinated, groomed, scientifically combed, and has a comprehensive solution. Regardless of any arena, athletes can compete fully when the rules of the referee are well established and the site is flexibly regulated.
Misunderstanding 4 Responsibility for rectification is to observe the autumn
There is also a view that the responsibility for supervision is to be severely punished, and it is obvious that there are any problems that are severely punished and severely blamed. This view is also justified. However, it is also the responsibility. The Western state organs are strictly and flexible in their implementation. They do not take measures such as punishment, consolidation, suspension, customs, and sales as the main means, but scientifically sort out the crux of the problem. In the face of new problems, we will continue to investigate, counsel, guide, guide the New Deal, and be flexible. We will integrate rigidness and flexibility, coordinate resources and strength to solve problems and contradictions, achieve scientific fineness and social balance, and seek a comprehensive coping mechanism. And measures to guide irregular events or emergencies to a reasonable, healthy, and regular development track, which will achieve smooth medical and social order while quelling chaos or emergency.
Zui is typically a Western national anti-terrorism national strategic reserve against Brucella immunoglobulins and anti-B. anthracis immunoglobulins in a series of terrorist attacks in Western countries.
Misunderstanding 5 Blood product gap can be filled by import
Another media view is that the product gap in the market is large, it is better to open the country to import medicines to meet demand. The author believes that this is not a long-term solution.
Not to mention the hidden dangers of the emergence of new viruses, that is, a large number of imported blood products are not in line with the spirit advocated by the WHO, because 80% of the world's population is not safely transfused and treated, and it is not possible to open the country; in addition, it is expensive abroad. The price of medicines is not in line with the purpose of “low level, wide coverage, and health for everyone†in China's medical care. The important thing is that once a terrorist attack or local war situation occurs, blood products that are the main rescue drugs on the battlefield are not guaranteed. What is the emergency ambulance and surgical medication for officers and soldiers on the battlefield? In particular, Zui has data showing that the increase in human albumin use in major western countries is greater than that of China. Can we expect to import a large amount of strategic materials?
Misunderstanding 6 One of the causes of tension is clinical abuse
It is worth noting that there is a paradox that one of the reasons for the current market shortage is caused by the abuse of ordinary people and clinical hospitals. This is an arbitrary conclusion. The author has been in the hospital for more than 10 years, and after years of hospital visits and market research, I found that in terms of human albumin, the proportion of unreasonable prescriptions in the central city is about 6% to 7%, and the proportion of unreasonable prescriptions in second-tier cities and rural areas is more. At 15%, the average compound ratio of the two is about 12% (almost fell to zero in 2007), while the market supply fell by 36% to 40% in 2007, the gap is as many as several million bottles, and the hospital almost has albumin resources. Controlled in the hands of the dean for the operation or rescue of key cases, some medical institutions even printed a quota of white protein bills, assigned the main department directors to limit the number of people, limited disease, limited prescription application; in addition, the vast rural The average income of the population is not high, so it is impossible for them to spend hard-earned money to consume human albumin of up to 360 yuan.
Misunderstanding 7 The central blood station is confused with the concept of apheresis plasma station
Before 2007, the original blood station belonged to the two-track system coexisting management, and the blood stations that donated blood donated to the national health institutions and public welfare institutions (national management, personnel system, administrative funding, blood supply hospitals and appropriate hospital charges), existing The single pulping station was gradually established from 1984. It mainly refers to the regulations of the Ministry of Health, and adopts multi-party fund-raising, self-financing, and subsidies for the payment of subsidies. It is under the jurisdiction of the Ministry of Health or the management of the pulp supplier.
In addition to the certificate issued by the Ministry of Health, the single pulping station shall be reviewed annually for review (unqualified rectification within a time limit - revocation - delisting). Since 2007, it has been divested from the national policy system (Document No. 118 of the Ministry of Health) and has been acquired by various manufacturers to become the raw material source workshop of the enterprise (implementing the GMP management specification for the pulp station).
"
Most people think that the plasma station is a blood station. It is generally believed that blood stations are donating blood for free and should not be paid. Some supervisory department leaders also regard the pulp station and the blood station as the same kind of business, and manage it according to the standard of unpaid blood stations.
In fact, the plasma station is quite different from the blood station in terms of workflow, scope, product nature and safety performance. The blood donation collected by the blood station is whole blood (no mechanical separation except for the blood component), and one unit can be collected in a few minutes, and directly passed to the patient after passing the test. The blood plasma collected by the plasma station is a part of the blood component separated by an automatic pulping machine (using disposable equipment). It takes about 30 to 40 minutes to collect one part; and it must be tested before it can be collected; the collected plasma It is also necessary to carry out unified re-examination before it can be put into production of blood products (using high-tech virus inactivation technology, high product safety), used to rescue critically ill patients.
Misunderstanding 8 The blood collection of the pulp station is not standardized and belongs to the target of attack.
The setting of a single pulping station cannot be in the same administrative area as an unpaid blood station because of the document, so most of them are in mountainous areas or border areas where traffic is blocked. From 1998 to 2007, several times of governance and rectification have been very effective in terms of governance direction and effect. The government has effectively cracked down on illegal/illegal blood collection behaviors, such as over-exploitation, frequent mining, cross-regional mining, and imposter replacement. After the typical incident was exposed, the public opinion said that the management of the blood supply station was chaotic, and there were many problems. The heavy punches attacked and severely cracked. Many provinces even banned the single pulping station, and there were many mentality and signs of shutting down and then quickly.
It should be pointed out here that some single pulping stations do have illegal/illegal behavior, but it does not mean that all pulp stations have violations. Now that the single pulping station is under the pressure of the public, the difficult situation of difficult survival is very well known. If there is no staff in the pulp station to persuade the supplier, and recruit the donor, how can the blood products that replace the blood transfusion treatment be in the hospital? Play a therapeutic and rescue role? How can the current severe rescue, abnormal pregnancy bleeding treatment, the rise of neonatal birth survival rate and the current medical organ transplant surgery and complex cutting-edge surgery smoothly carried out? Many of the current media reports are too one-sided, reporting propaganda and distorting, so that the people have a negative impression of the paid donation, pushing the single pulping station to the edge of being “demonizedâ€.
It can be said that the safety of blood products in China is currently in a good period of history. Some of China's blood products are successfully registered in Western countries with near-demanding quality requirements.
"China's blood products industry has gradually developed from the six major organisms of the Ministry of Health since the founding of the People's Republic of China. In the middle, there are foreign capital, * and local and private capital. The production technology has experienced raw materials from the placenta, The whole blood is separated into the stage of single mining. In response to the WHO call for “blood products should be self-sufficientâ€, in the past 20 years, China’s blood products industry has developed and expanded greatly, forming more than 30 enterprises. With an initial and loose industrial system with an annual output value of about 8 billion yuan (including vaccines), there are more than 10 mature varieties (plus more than 20 kinds of vaccines), which meet the treatment needs of clinical diseases in China. China's blood products industry has made a qualitative leap from raw material collection and production facilities, process level, quality control, and product efficacy. Some varieties are close to the international level, and the safety and effectiveness of products have been guaranteed.
However, we must also see that compared with developed countries, China's blood products industry still has shortcomings such as shortage of raw materials, poor comprehensive utilization of resources, hidden dangers of safety, and lagging certification standards, especially in the procurement of pulp standards and slurry feeders. There are still some gaps in management, quality control standards, technical processes, independent innovation, new product development, and internal quality and industry concepts of end products. In this regard, the author makes an in-depth discussion on the status quo and prospects of the plasma industry and the management and remediation of the slurry workers. â€
China's rectification and treatment of the raw material plasma market has achieved remarkable results over the years, ensuring the safety of upstream raw materials. From a comparative perspective, the system and management of the blood products industry, the strengthening of laws and regulations, the enforcement measures, and the safety of products are all in a good period and stage of history. It is effective in rectifying and strengthening supervision of raw material plasma and upstream markets. In order to ensure the safe application of blood products and eradicate hidden dangers in safety management, China's relevant functional departments have jointly reorganized the blood products industry. Especially since 1998-2007, China has carried out several treatments on the pulp industry, which is powerful. It has cracked down on illegal blood collection and supply, further safeguarded the safety of upstream raw material blood, shut down nearly 40 non-standard single-paste stations, and banned GMP certificates for three companies, further standardizing the supply of pulpers and pulp stations. Management avoids personal injury and medical and social problems caused by product safety incidents in Western countries. However, while the industry is regulating and developing, it also has some new problems that deserve our deep reflection.
Industry status
At present, the amount of pulp collected by domestic blood products manufacturers has dropped sharply, from about 4,960 tons in the historical peak to about 2,700 tons in 2007; almost every company's production capacity has dropped by 35% to 50%; and domestic blood products are in short supply. The phenomenon has not seen a trend of fundamental warming or easing. It is difficult for people to use drugs and hospitals for normal surgery and emergency rescue drugs, especially in some second-tier cities. The normal medical order is disturbed and affected, and even the unfortunate incident of hemophilia patients death due to drug-free treatment. Looking at the pulping situation in 2008, this situation does not necessarily show signs of a turnaround.
China is a big country with a population of 1.3 billion. It should have a rich plasma base and resources, and blood products should not be scarce. Compared with the United States, which has a population of more than 300 million people, its management of the pulp industry is orderly. The team of pulpers is bigger and more orderly than ours. The amount of pulp is 3 to 4 times that of China, and the production capacity and variety are abundant and very Abundant. Not only do we meet the needs ourselves, but there are also a large number of products exported to foreign countries. This phenomenon is worthy of our in-depth study.
At present, due to the reduction of the supply of pulp, the hospital terminal has a comprehensive tightening of blood products such as human serum albumin, intravenous gamma to various coagulation factors, and the medical needs and market supply gaps are large, which has caused the decision-making level and the competent authorities. Value and attention. It should be said that in recent years, the state has introduced a series of management policies to effectively rectify the market. However, some of the problems that have followed have gradually emerged: market blood products are tight and the goods are inhabited, major surgery and difficult surgery and rescue drugs. Difficult to find, the normal medical order of some hospitals is affected, and the national war preparation needs are insufficient.
Response plan
At present, the industry's original intention and desire for the management of pulp stations and slurry workers is good, but the new problems brought about are also severe. The author believes that the blood products industry should comprehensively analyze the crux of the problem from macro to micro. With reference to the experience, historical trajectory, nodes and operational norms of developed countries, it is necessary to have long-term and comprehensive solutions and guidelines, and then formulate scientific and comprehensive. Improve governance measures in stages to form a holistic and comprehensive strategic layout and program details:
First, in the principle of rectification, we must go online, but we must also provide flexible counseling in specific inspections. Second, while attaching importance to typical and prominent events, we should not focus on the details, the grass and the soldiers, and the strictness (strict, whole, stop, Third, in the strict supervision, it is necessary to assist with new rules, new policy guidelines and follow-up guidance; Fourth, while paying attention to indicators and paying attention to responsibility, we must also respect scientific laws and international operating standards; While measures are frequently strengthened and strengthened, countermeasures and remedial measures should be formulated in response to social problems, sequelae and market shortages. In this way, the process of comprehensive rectification of the plasma industry in China can be accelerated, regulations and rules are more comprehensive, quality control and The standard further jumped to form a continuous and long-lasting mechanism, regulatory order and industrial environment. While safeguarding domestic medical and national war preparation needs, it also narrowed the gap with advanced countries in cognitive concepts, quality standards and certification systems. China's blood products industry has become bigger and stronger, making it the driving force and driving engine for the development of China's biological products.
Industry misunderstanding
Due to the shortage of blood products, some misunderstandings of conflicts and understandings have emerged in public opinion, the media and other industries:
Misunderstanding 1 Manufacturers hoarding, pushing up prices
First of all, there is a general argument in the media and public opinion in the society that the lack of supply of products is the result of hoarding of manufacturers. In fact, in 2007, the amount of pulp in China fell from about 4,960 tons in the peak of 2003 to about 2,700 tons in 2007. In addition to the conversion of pulp stations and GMP reform, the pulp consumption of each factory is 35% to 50%. The decline in production, production shortages lead to a reduction in products, especially clotting factor products. Now the state has supervised the high-risk industry for blood products, and the number of units in each batch of manufactured products has been accurately determined by the batch issuance system. Coupled with the spot checks of the resident supervisors, the products are included in the control of the supervision network, plus It is almost impossible for manufacturers to hoard the inspections of the national drug supervision system.
Misunderstanding 2
There is also a public opinion that it is not going to be a mess if it is strictly controlled. This is true to some extent. This phenomenon has a deep national background and historical origins: any remediation is a responsibility, a phased task, but often lacks a comprehensive view and long-term planning, not in one step, to develop a long-term mechanism and thorough The solution requires a sense of decision-making and a strategic vision. Strict supervision is correct, but there should be corresponding measures and remedial measures for the current contradiction and social problems derived from this, which should also be part of comprehensive governance measures.
Misunderstanding 3 The management of the pulp station is a matter of the enterprise, and the functional agency is only responsible for inspection and remediation.
After the conversion of the pulp station, it is indeed the internal management of the enterprise, but the pulp station or the pulping company is also implemented in accordance with the GMP management regulations. How long does it take to guarantee the authority and rigor of the current standard? How long will it take to make changes? And improvement? Why are our specifications and SOPs (Standard Operating Procedures) in the process of repeated revision and improvement? If there are authoritative standards that can be used for reference, can we refer to and absorb acceptance?
How to manage the pulp station and how to manage the pulp company is definitely the responsibility of the company. However, as an “athlete†(enterprise), the process of adaptation needs to be adapted under repeated revision rules. At the same time, it is involved in the specific operation, “ Whether the referee is fully engaged and rationally coordinated, groomed, scientifically combed, and has a comprehensive solution. Regardless of any arena, athletes can compete fully when the rules of the referee are well established and the site is flexibly regulated.
Misunderstanding 4 Responsibility for rectification is to observe the autumn
There is also a view that the responsibility for supervision is to be severely punished, and it is obvious that there are any problems that are severely punished and severely blamed. This view is also justified. However, it is also the responsibility. The Western state organs are strictly and flexible in their implementation. They do not take measures such as punishment, consolidation, suspension, customs, and sales as the main means, but scientifically sort out the crux of the problem. In the face of new problems, we will continue to investigate, counsel, guide, guide the New Deal, and be flexible. We will integrate rigidness and flexibility, coordinate resources and strength to solve problems and contradictions, achieve scientific fineness and social balance, and seek a comprehensive coping mechanism. And measures to guide irregular events or emergencies to a reasonable, healthy, and regular development track, which will achieve smooth medical and social order while quelling chaos or emergency.
Zui is typically a Western national anti-terrorism national strategic reserve against Brucella immunoglobulins and anti-B. anthracis immunoglobulins in a series of terrorist attacks in Western countries.
Misunderstanding 5 Blood product gap can be filled by import
Another media view is that the product gap in the market is large, it is better to open the country to import medicines to meet demand. The author believes that this is not a long-term solution.
Not to mention the hidden dangers of the emergence of new viruses, that is, a large number of imported blood products are not in line with the spirit advocated by the WHO, because 80% of the world's population is not safely transfused and treated, and it is not possible to open the country; in addition, it is expensive abroad. The price of medicines is not in line with the purpose of “low level, wide coverage, and health for everyone†in China's medical care. The important thing is that once a terrorist attack or local war situation occurs, blood products that are the main rescue drugs on the battlefield are not guaranteed. What is the emergency ambulance and surgical medication for officers and soldiers on the battlefield? In particular, Zui has data showing that the increase in human albumin use in major western countries is greater than that of China. Can we expect to import a large amount of strategic materials?
Misunderstanding 6 One of the causes of tension is clinical abuse
It is worth noting that there is a paradox that one of the reasons for the current market shortage is caused by the abuse of ordinary people and clinical hospitals. This is an arbitrary conclusion. The author has been in the hospital for more than 10 years, and after years of hospital visits and market research, I found that in terms of human albumin, the proportion of unreasonable prescriptions in the central city is about 6% to 7%, and the proportion of unreasonable prescriptions in second-tier cities and rural areas is more. At 15%, the average compound ratio of the two is about 12% (almost fell to zero in 2007), while the market supply fell by 36% to 40% in 2007, the gap is as many as several million bottles, and the hospital almost has albumin resources. Controlled in the hands of the dean for the operation or rescue of key cases, some medical institutions even printed a quota of white protein bills, assigned the main department directors to limit the number of people, limited disease, limited prescription application; in addition, the vast rural The average income of the population is not high, so it is impossible for them to spend hard-earned money to consume human albumin of up to 360 yuan.
Misunderstanding 7 The central blood station is confused with the concept of apheresis plasma station
Before 2007, the original blood station belonged to the two-track system coexisting management, and the blood stations that donated blood donated to the national health institutions and public welfare institutions (national management, personnel system, administrative funding, blood supply hospitals and appropriate hospital charges), existing The single pulping station was gradually established from 1984. It mainly refers to the regulations of the Ministry of Health, and adopts multi-party fund-raising, self-financing, and subsidies for the payment of subsidies. It is under the jurisdiction of the Ministry of Health or the management of the pulp supplier.
In addition to the certificate issued by the Ministry of Health, the single pulping station shall be reviewed annually for review (unqualified rectification within a time limit - revocation - delisting). Since 2007, it has been divested from the national policy system (Document No. 118 of the Ministry of Health) and has been acquired by various manufacturers to become the raw material source workshop of the enterprise (implementing the GMP management specification for the pulp station).
"
Most people think that the plasma station is a blood station. It is generally believed that blood stations are donating blood for free and should not be paid. Some supervisory department leaders also regard the pulp station and the blood station as the same kind of business, and manage it according to the standard of unpaid blood stations.
In fact, the plasma station is quite different from the blood station in terms of workflow, scope, product nature and safety performance. The blood donation collected by the blood station is whole blood (no mechanical separation except for the blood component), and one unit can be collected in a few minutes, and directly passed to the patient after passing the test. The blood plasma collected by the plasma station is a part of the blood component separated by an automatic pulping machine (using disposable equipment). It takes about 30 to 40 minutes to collect one part; and it must be tested before it can be collected; the collected plasma It is also necessary to carry out unified re-examination before it can be put into production of blood products (using high-tech virus inactivation technology, high product safety), used to rescue critically ill patients.
Misunderstanding 8 The blood collection of the pulp station is not standardized and belongs to the target of attack.
The setting of a single pulping station cannot be in the same administrative area as an unpaid blood station because of the document, so most of them are in mountainous areas or border areas where traffic is blocked. From 1998 to 2007, several times of governance and rectification have been very effective in terms of governance direction and effect. The government has effectively cracked down on illegal/illegal blood collection behaviors, such as over-exploitation, frequent mining, cross-regional mining, and imposter replacement. After the typical incident was exposed, the public opinion said that the management of the blood supply station was chaotic, and there were many problems. The heavy punches attacked and severely cracked. Many provinces even banned the single pulping station, and there were many mentality and signs of shutting down and then quickly.
It should be pointed out here that some single pulping stations do have illegal/illegal behavior, but it does not mean that all pulp stations have violations. Now that the single pulping station is under the pressure of the public, the difficult situation of difficult survival is very well known. If there is no staff in the pulp station to persuade the supplier, and recruit the donor, how can the blood products that replace the blood transfusion treatment be in the hospital? Play a therapeutic and rescue role? How can the current severe rescue, abnormal pregnancy bleeding treatment, the rise of neonatal birth survival rate and the current medical organ transplant surgery and complex cutting-edge surgery smoothly carried out? Many of the current media reports are too one-sided, reporting propaganda and distorting, so that the people have a negative impression of the paid donation, pushing the single pulping station to the edge of being “demonizedâ€.
It can be said that the safety of blood products in China is currently in a good period of history. Some of China's blood products are successfully registered in Western countries with near-demanding quality requirements.
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