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Medical News, April 1st
The topic of "one-time high-consumption multiplexing" reappears, and the National Health Commission expressed its position
Recently, the National Health Commission issued the "Response to Recommendation No.
9780 of the Third Session of the 13th National People’s Congress" (hereinafter referred to as the "Response").
"Recommendations for the Catalog of Disposable Devices", the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
9780 of the Third Session of the 13th National People’s Congress" (hereinafter referred to as the "Response").
"Recommendations for the Catalog of Disposable Devices", the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
In the next step, the National Health Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the catalog of single-use medical devices to balance the safety and economy of reuse of single-use medical devices.
And will also carry out the following work:
And will also carry out the following work:
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices.
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
For a long time, regarding the reusability of single-use medical devices, the state has been in the “Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases”, “Regulations on the Supervision and Administration of Medical Devices,” “Disinfection Management Measures”, “Nosocomial Infection Management Measures”, The Regulations for the Supervision and Administration of Bacteria Medical Devices and other documents are expressly prohibited.
The release of this "Response" document has once again attracted the attention of the industry on the topic of reuse of disposable consumables.
The inexhaustible market demand will prop up the market of hundreds of billions
Before the 1970s, most medical devices were considered "reusable.
" Because most of them are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution.
With the development of medical technology and the use of plastics and other materials in medical products, "disposable medical consumables" have gradually become known to people.
" Because most of them are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution.
With the development of medical technology and the use of plastics and other materials in medical products, "disposable medical consumables" have gradually become known to people.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
At present, there are hundreds of disposable medical consumables on the market, among which medical metal needles, medical catheters, medical latex gloves, disposable syringes and other products account for a relatively large proportion.
In addition, orthopedic implantation is also one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal internal fixation implants, and artificial Joints and so on.
As people's living standards improve, health awareness increases, and hospitals' awareness of protecting medical staff and patients increases, the demand for disposable medical consumables is increasing.
This is also reflected in the data that disposable medical consumables account for the total expenditure of patients: According to statistics, disposable medical consumables account for 22%-30% of the total expenditures of all inpatients, and account for about 50% of the medical expenditures of surgical patients.
This is also reflected in the data that disposable medical consumables account for the total expenditure of patients: According to statistics, disposable medical consumables account for 22%-30% of the total expenditures of all inpatients, and account for about 50% of the medical expenditures of surgical patients.
In addition, data from the China Medical Materials Association show that in 2019, China's disposable medical device market reached 210.
2 billion yuan.
With strong and inexhaustible market demand, the demand for disposable medical consumables will further expand in the future.
It is estimated that the market size will reach 546.
8 billion yuan in 2025, with a compound annual growth rate of 17.
3% during the period.
2 billion yuan.
With strong and inexhaustible market demand, the demand for disposable medical consumables will further expand in the future.
It is estimated that the market size will reach 546.
8 billion yuan in 2025, with a compound annual growth rate of 17.
3% during the period.
What is the difficulty of "disposable consumable reuse"?
With a market scale of 100 billion yuan, with the further increase in the consumption of disposable medical consumables in the future, it will cause a huge waste of resources.
For patients and medical institutions, the reuse of disposable medical consumables is one of the cost-saving measures and can also reduce the amount of medical waste.
In addition, European developed countries such as Germany and Denmark have implemented the safe reuse of disposable high-value medical consumables, forcing manufacturers to further reduce prices for products, saving the country and patients.
Although there are huge economic benefits, there are many uncontrollable factors in reuse:
1.
Disinfection safety: The competent department of the medical device manufacturer is the drug supervision department.
The manufacturer chooses "single use" when applying for registration.
The drug supervision department will approve the registration according to the "single use", and the manufacturer will not provide disposable medical treatment.
The method of cleaning, disinfecting and sterilizing equipment reuse.
Disinfection safety: The competent department of the medical device manufacturer is the drug supervision department.
The manufacturer chooses "single use" when applying for registration.
The drug supervision department will approve the registration according to the "single use", and the manufacturer will not provide disposable medical treatment.
The method of cleaning, disinfecting and sterilizing equipment reuse.
At present, the hospital disinfection supply center and the independent disinfection supply center are currently in the process of gradual maturity of technology, and the level of disinfection supply is limited, which can easily cause cross-infection or secondary infection, which directly involves patient safety.
2.
Product structure: At present, many disposable medical devices are destroyed after use and cannot be reused.
The existing structure needs to be improved in order to be reused.
Product structure: At present, many disposable medical devices are destroyed after use and cannot be reused.
The existing structure needs to be improved in order to be reused.
Based on these factors, the National Health Commission once again reiterated in the “Reply” document that in accordance with Article 35 and Article 68 of the “Regulations on the Supervision and Administration of Medical Devices” (revised in 2017), single-use medical devices shall not be duplicated.
For use, the medical institution as a user unit will bear the legal responsibility of being warned, fined, and suspended from production and business by the relevant authorities if it reuses single-use medical devices.
For use, the medical institution as a user unit will bear the legal responsibility of being warned, fined, and suspended from production and business by the relevant authorities if it reuses single-use medical devices.
In addition, in the "Reply" document, the National Health Commission mentioned that it requires or encourages enterprises to develop and produce reusable medical consumables, but it is still difficult to promote the production of reusable medical consumables.
1.
In terms of manufacturer selection, the approval process for disposable medical consumables is simple, and the listing is faster.
For manufacturers, it is easier to recover R&D costs than reusable medical consumables.
Therefore, in terms of production willingness, manufacturers are more inclined to "one time" Sexual use".
For example, Johnson & Johnson’s ultrasonic scalpel and single-use ultrasonic scalpel can be marketed quickly, and it may take 2 years for the approval of the reusable ultrasonic scalpel.
In terms of manufacturer selection, the approval process for disposable medical consumables is simple, and the listing is faster.
For manufacturers, it is easier to recover R&D costs than reusable medical consumables.
Therefore, in terms of production willingness, manufacturers are more inclined to "one time" Sexual use".
For example, Johnson & Johnson’s ultrasonic scalpel and single-use ultrasonic scalpel can be marketed quickly, and it may take 2 years for the approval of the reusable ultrasonic scalpel.
2.
In terms of hospital selection, with the development of minimally invasive surgery and the improvement of patients' health awareness, doctors are relatively more willing to choose disposable medical consumables.
Moreover, the purchase price of disposable medical consumables is relatively cheap.
Therefore, hospitals also prefer to purchase disposable consumables.
This has further promoted the development of disposable medical consumables.
The market for reusable consumables has shrunk accordingly, and manufacturers are more willing to use disposable consumables.
More funds will be invested in research and development of medical consumables.
In terms of hospital selection, with the development of minimally invasive surgery and the improvement of patients' health awareness, doctors are relatively more willing to choose disposable medical consumables.
Moreover, the purchase price of disposable medical consumables is relatively cheap.
Therefore, hospitals also prefer to purchase disposable consumables.
This has further promoted the development of disposable medical consumables.
The market for reusable consumables has shrunk accordingly, and manufacturers are more willing to use disposable consumables.
More funds will be invested in research and development of medical consumables.
In recent years, the reuse frequency of disposable medical consumables has been mentioned, especially the huge waste caused by disposable high-value medical consumables has gradually attracted the attention of the industry.
However, reuse involves many issues such as disinfection safety, product structure, and so on.
From the current point of view, whether or not disposable medical consumables can be reused in the future is still awaiting research and advancement by relevant departments.
However, reuse involves many issues such as disinfection safety, product structure, and so on.
From the current point of view, whether or not disposable medical consumables can be reused in the future is still awaiting research and advancement by relevant departments.
Medical News, April 1st
The topic of "one-time high-consumption multiplexing" reappears, and the National Health Commission expressed its position
Recently, the National Health Commission issued the "Response to Recommendation No.
9780 of the Third Session of the 13th National People’s Congress" (hereinafter referred to as the "Response").
"Recommendations for the Catalog of Disposable Devices", the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
9780 of the Third Session of the 13th National People’s Congress" (hereinafter referred to as the "Response").
"Recommendations for the Catalog of Disposable Devices", the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
In the next step, the National Health Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the catalog of single-use medical devices to balance the safety and economy of reuse of single-use medical devices.
And will also carry out the following work:
And will also carry out the following work:
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices.
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
For a long time, regarding the reusability of single-use medical devices, the state has been in the “Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases”, “Regulations on the Supervision and Administration of Medical Devices,” “Disinfection Management Measures”, “Nosocomial Infection Management Measures”, The Regulations for the Supervision and Administration of Bacteria Medical Devices and other documents are expressly prohibited.
The release of this "Response" document has once again attracted the attention of the industry on the topic of reuse of disposable consumables.
The inexhaustible market demand will prop up the market of hundreds of billions
Before the 1970s, most medical devices were considered "reusable.
" Because most of them are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution.
With the development of medical technology and the use of plastics and other materials in medical products, "disposable medical consumables" have gradually become known to people.
" Because most of them are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution.
With the development of medical technology and the use of plastics and other materials in medical products, "disposable medical consumables" have gradually become known to people.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
At present, there are hundreds of disposable medical consumables on the market, among which medical metal needles, medical catheters, medical latex gloves, disposable syringes and other products account for a relatively large proportion.
In addition, orthopedic implantation is also one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal internal fixation implants, and artificial Joints and so on.
As people's living standards improve, health awareness increases, and hospitals' awareness of protecting medical staff and patients increases, the demand for disposable medical consumables is increasing.
This is also reflected in the data that disposable medical consumables account for the total expenditure of patients: According to statistics, disposable medical consumables account for 22%-30% of the total expenditures of all inpatients, and account for about 50% of the medical expenditures of surgical patients.
This is also reflected in the data that disposable medical consumables account for the total expenditure of patients: According to statistics, disposable medical consumables account for 22%-30% of the total expenditures of all inpatients, and account for about 50% of the medical expenditures of surgical patients.
In addition, data from the China Medical Materials Association show that in 2019, China's disposable medical device market reached 210.
2 billion yuan.
With strong and inexhaustible market demand, the demand for disposable medical consumables will further expand in the future.
It is estimated that the market size will reach 546.
8 billion yuan in 2025, with a compound annual growth rate of 17.
3% during the period.
2 billion yuan.
With strong and inexhaustible market demand, the demand for disposable medical consumables will further expand in the future.
It is estimated that the market size will reach 546.
8 billion yuan in 2025, with a compound annual growth rate of 17.
3% during the period.
What is the difficulty of "disposable consumable reuse"?
With a market scale of 100 billion yuan, with the further increase in the consumption of disposable medical consumables in the future, it will cause a huge waste of resources.
For patients and medical institutions, the reuse of disposable medical consumables is one of the cost-saving measures and can also reduce the amount of medical waste.
In addition, European developed countries such as Germany and Denmark have implemented the safe reuse of disposable high-value medical consumables, forcing manufacturers to further reduce prices for products, saving the country and patients.
Although there are huge economic benefits, there are many uncontrollable factors in reuse:
1.
Disinfection safety: The competent department of the medical device manufacturer is the drug supervision department.
The manufacturer chooses "single use" when applying for registration.
The drug supervision department will approve the registration according to the "single use", and the manufacturer will not provide disposable medical treatment.
The method of cleaning, disinfecting and sterilizing equipment reuse.
Disinfection safety: The competent department of the medical device manufacturer is the drug supervision department.
The manufacturer chooses "single use" when applying for registration.
The drug supervision department will approve the registration according to the "single use", and the manufacturer will not provide disposable medical treatment.
The method of cleaning, disinfecting and sterilizing equipment reuse.
At present, the hospital disinfection supply center and the independent disinfection supply center are currently in the process of gradual maturity of technology, and the level of disinfection supply is limited, which can easily cause cross-infection or secondary infection, which directly involves patient safety.
2.
Product structure: At present, many disposable medical devices are destroyed after use and cannot be reused.
The existing structure needs to be improved in order to be reused.
Product structure: At present, many disposable medical devices are destroyed after use and cannot be reused.
The existing structure needs to be improved in order to be reused.
Based on these factors, the National Health Commission once again reiterated in the “Reply” document that in accordance with Article 35 and Article 68 of the “Regulations on the Supervision and Administration of Medical Devices” (revised in 2017), single-use medical devices shall not be duplicated.
For use, the medical institution as a user unit will bear the legal responsibility of being warned, fined, and suspended from production and business by the relevant authorities if it reuses single-use medical devices.
For use, the medical institution as a user unit will bear the legal responsibility of being warned, fined, and suspended from production and business by the relevant authorities if it reuses single-use medical devices.
In addition, in the "Reply" document, the National Health Commission mentioned that it requires or encourages enterprises to develop and produce reusable medical consumables, but it is still difficult to promote the production of reusable medical consumables.
1.
In terms of manufacturer selection, the approval process for disposable medical consumables is simple, and the listing is faster.
For manufacturers, it is easier to recover R&D costs than reusable medical consumables.
Therefore, in terms of production willingness, manufacturers are more inclined to "one time" Sexual use".
For example, Johnson & Johnson’s ultrasonic scalpel and single-use ultrasonic scalpel can be marketed quickly, and it may take 2 years for the approval of the reusable ultrasonic scalpel.
In terms of manufacturer selection, the approval process for disposable medical consumables is simple, and the listing is faster.
For manufacturers, it is easier to recover R&D costs than reusable medical consumables.
Therefore, in terms of production willingness, manufacturers are more inclined to "one time" Sexual use".
For example, Johnson & Johnson’s ultrasonic scalpel and single-use ultrasonic scalpel can be marketed quickly, and it may take 2 years for the approval of the reusable ultrasonic scalpel.
2.
In terms of hospital selection, with the development of minimally invasive surgery and the improvement of patients' health awareness, doctors are relatively more willing to choose disposable medical consumables.
Moreover, the purchase price of disposable medical consumables is relatively cheap.
Therefore, hospitals also prefer to purchase disposable consumables.
This has further promoted the development of disposable medical consumables.
The market for reusable consumables has shrunk accordingly, and manufacturers are more willing to use disposable consumables.
More funds will be invested in research and development of medical consumables.
In terms of hospital selection, with the development of minimally invasive surgery and the improvement of patients' health awareness, doctors are relatively more willing to choose disposable medical consumables.
Moreover, the purchase price of disposable medical consumables is relatively cheap.
Therefore, hospitals also prefer to purchase disposable consumables.
This has further promoted the development of disposable medical consumables.
The market for reusable consumables has shrunk accordingly, and manufacturers are more willing to use disposable consumables.
More funds will be invested in research and development of medical consumables.
In recent years, the reuse frequency of disposable medical consumables has been mentioned, especially the huge waste caused by disposable high-value medical consumables has gradually attracted the attention of the industry.
However, reuse involves many issues such as disinfection safety, product structure, and so on.
From the current point of view, whether or not disposable medical consumables can be reused in the future is still awaiting research and advancement by relevant departments.
However, reuse involves many issues such as disinfection safety, product structure, and so on.
From the current point of view, whether or not disposable medical consumables can be reused in the future is still awaiting research and advancement by relevant departments.
Medical News, April 1st
The topic of "one-time high-consumption multiplexing" reappears, and the National Health Commission expressed its position
The topic of "one-time high-consumption multiplexing" reappears, and the National Health Commission expressed its position Recently, the National Health Commission issued the "Response to Recommendation No.
9780 of the Third Session of the 13th National People’s Congress" (hereinafter referred to as the "Response").
"Recommendations for the Catalog of Disposable Devices", the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
9780 of the Third Session of the 13th National People’s Congress" (hereinafter referred to as the "Response").
"Recommendations for the Catalog of Disposable Devices", the National Health Commission stated that the one-time use of high-value medical consumables may cause waste of resources, environmental pollution and rising medical costs.
In practice, some medical consumables can be reused.
In the next step, the National Health Commission will follow the principles of safety, effectiveness and economy, and actively cooperate with the State Food and Drug Administration to adjust the catalog of single-use medical devices to balance the safety and economy of reuse of single-use medical devices.
And will also carry out the following work:
And will also carry out the following work:
First, it is recommended that the drug regulatory department requires or encourages companies to develop and produce reusable medical consumables when approving the marketing of medical devices.
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
For those that cannot be reused, they should try their best to choose corresponding alternative products or materials to avoid setting up unreasonable technical barriers.
The second is to cooperate with the drug regulatory department to strengthen research and demonstration, and to support the reuse of clinical norms that can be reused in the diagnosis and treatment process and can be guaranteed to be safe and effective, not included in the catalog of single-use medical devices.
For a long time, regarding the reusability of single-use medical devices, the state has been in the “Law of the People’s Republic of China on the Prevention and Control of Infectious Diseases”, “Regulations on the Supervision and Administration of Medical Devices,” “Disinfection Management Measures”, “Nosocomial Infection Management Measures”, The Regulations for the Supervision and Administration of Bacteria Medical Devices and other documents are expressly prohibited.
The release of this "Response" document has once again attracted the attention of the industry on the topic of reuse of disposable consumables.
The inexhaustible market demand will prop up the market of hundreds of billions
The inexhaustible market demand will prop up the market of hundreds of billions Before the 1970s, most medical devices were considered "reusable.
" Because most of them are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution.
With the development of medical technology and the use of plastics and other materials in medical products, "disposable medical consumables" have gradually become known to people.
" Because most of them are made of glass, rubber, and metal materials, such as probes and surgical instruments, they can be reused after a little wipe, soaked in a disinfectant solution.
With the development of medical technology and the use of plastics and other materials in medical products, "disposable medical consumables" have gradually become known to people.
Whether medical consumables are for one-time use is determined during the registration approval or filing process, and the instructions for use have clearly stipulated.
According to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
Medicine, medicine, medicineAccording to Article 6 of the Regulations on the Supervision and Administration of Medical Devices (revised in 2017), the list of disposable medical devices shall be formulated, adjusted and published by the food and drug regulatory authority of the State Council in conjunction with the health and family planning authority of the State Council.
At present, there are hundreds of disposable medical consumables on the market, among which medical metal needles, medical catheters, medical latex gloves, disposable syringes and other products account for a relatively large proportion.
In addition, orthopedic implantation is also one of the largest sub-sectors in the disposable medical device industry, mainly including bone joint implants and joint implants, such as bone plates, bone screws, intramedullary nails, spinal internal fixation implants, and artificial Joints and so on.
As people's living standards improve, health awareness increases, and hospitals' awareness of protecting medical staff and patients increases, the demand for disposable medical consumables is increasing.
This is also reflected in the data that disposable medical consumables account for the total expenditure of patients: According to statistics, disposable medical consumables account for 22%-30% of the total expenditures of all inpatients, and account for about 50% of the medical expenditures of surgical patients.
This is also reflected in the data that disposable medical consumables account for the total expenditure of patients: According to statistics, disposable medical consumables account for 22%-30% of the total expenditures of all inpatients, and account for about 50% of the medical expenditures of surgical patients.
In addition, data from the China Medical Materials Association show that in 2019, China's disposable medical device market reached 210.
2 billion yuan.
With strong and inexhaustible market demand, the demand for disposable medical consumables will further expand in the future.
It is estimated that the market size will reach 546.
8 billion yuan in 2025, with a compound annual growth rate of 17.
3% during the period.
Medicine Medicine Medicine Medical Device Medical Device Medical Device2 billion yuan.
With strong and inexhaustible market demand, the demand for disposable medical consumables will further expand in the future.
It is estimated that the market size will reach 546.
8 billion yuan in 2025, with a compound annual growth rate of 17.
3% during the period.
What is the difficulty of "disposable consumable reuse"?
What is the difficulty of "disposable consumable reuse"? With a market scale of 100 billion yuan, with the further increase in the consumption of disposable medical consumables in the future, it will cause a huge waste of resources.
For patients and medical institutions, the reuse of disposable medical consumables is one of the cost-saving measures and can also reduce the amount of medical waste.
In addition, European developed countries such as Germany and Denmark have implemented the safe reuse of disposable high-value medical consumables, forcing manufacturers to further reduce prices for products, saving the country and patients.
Although there are huge economic benefits, there are many uncontrollable factors in reuse:
1.
Disinfection safety: The competent department of the medical device manufacturer is the drug supervision department.
The manufacturer chooses "single use" when applying for registration.
The drug supervision department will approve the registration according to the "single use", and the manufacturer will not provide disposable medical treatment.
The method of cleaning, disinfecting and sterilizing equipment reuse.
Disinfection safety: The competent department of the medical device manufacturer is the drug supervision department.
The manufacturer chooses "single use" when applying for registration.
The drug supervision department will approve the registration according to the "single use", and the manufacturer will not provide disposable medical treatment.
The method of cleaning, disinfecting and sterilizing equipment reuse.
At present, the hospital disinfection supply center and the independent disinfection supply center are currently in the process of gradual maturity of technology, and the level of disinfection supply is limited, which can easily cause cross-infection or secondary infection, which directly involves patient safety.
2.
Product structure: At present, many disposable medical devices are destroyed after use and cannot be reused.
The existing structure needs to be improved in order to be reused.
Product structure: At present, many disposable medical devices are destroyed after use and cannot be reused.
The existing structure needs to be improved in order to be reused.
Based on these factors, the National Health Commission once again reiterated in the “Reply” document that in accordance with Article 35 and Article 68 of the “Regulations on the Supervision and Administration of Medical Devices” (revised in 2017), single-use medical devices shall not be duplicated.
For use, the medical institution as a user unit will bear the legal responsibility of being warned, fined, and suspended from production and business by the relevant authorities if it reuses single-use medical devices.
For use, the medical institution as a user unit will bear the legal responsibility of being warned, fined, and suspended from production and business by the relevant authorities if it reuses single-use medical devices.
In addition, in the "Reply" document, the National Health Commission mentioned that it requires or encourages enterprises to develop and produce reusable medical consumables, but it is still difficult to promote the production of reusable medical consumables.
Enterprise business enterprise 1.
In terms of manufacturer selection, the approval process for disposable medical consumables is simple, and the listing is faster.
For manufacturers, it is easier to recover R&D costs than reusable medical consumables.
Therefore, in terms of production willingness, manufacturers are more inclined to "one time" Sexual use".
For example, Johnson & Johnson’s ultrasonic scalpel and single-use ultrasonic scalpel can be marketed quickly, and it may take 2 years for the approval of the reusable ultrasonic scalpel.
In terms of manufacturer selection, the approval process for disposable medical consumables is simple, and the listing is faster.
For manufacturers, it is easier to recover R&D costs than reusable medical consumables.
Therefore, in terms of production willingness, manufacturers are more inclined to "one time" Sexual use".
For example, Johnson & Johnson’s ultrasonic scalpel and single-use ultrasonic scalpel can be marketed quickly, and it may take 2 years for the approval of the reusable ultrasonic scalpel.
2.
In terms of hospital selection, with the development of minimally invasive surgery and the improvement of patients' health awareness, doctors are relatively more willing to choose disposable medical consumables.
Moreover, the purchase price of disposable medical consumables is relatively cheap.
Therefore, hospitals also prefer to purchase disposable consumables.
This has further promoted the development of disposable medical consumables.
The market for reusable consumables has shrunk accordingly, and manufacturers are more willing to use disposable consumables.
More funds will be invested in research and development of medical consumables.
Hospital hospital hospitalIn terms of hospital selection, with the development of minimally invasive surgery and the improvement of patients' health awareness, doctors are relatively more willing to choose disposable medical consumables.
Moreover, the purchase price of disposable medical consumables is relatively cheap.
Therefore, hospitals also prefer to purchase disposable consumables.
This has further promoted the development of disposable medical consumables.
The market for reusable consumables has shrunk accordingly, and manufacturers are more willing to use disposable consumables.
More funds will be invested in research and development of medical consumables.
In recent years, the reuse frequency of disposable medical consumables has been mentioned, especially the huge waste caused by disposable high-value medical consumables has gradually attracted the attention of the industry.
However, reuse involves many issues such as disinfection safety, product structure, and so on.
From the current point of view, whether or not disposable medical consumables can be reused in the future is still awaiting research and advancement by relevant departments.
However, reuse involves many issues such as disinfection safety, product structure, and so on.
From the current point of view, whether or not disposable medical consumables can be reused in the future is still awaiting research and advancement by relevant departments.
