Disposable instruments, can open the multiplex gate

Release date: 2009-06-05

● Can I use the medical device for one time only once? With the development of medical technology, the industry is paying more and more attention to this issue.

● The successful experience of German multiplexed catheters has opened a door to exploring the issue of disposable medical device reuse.

● Industry experts pointed out that under the current situation, repeated use of some disposable medical devices can effectively reduce medical costs and meet the requirements of establishing a conservation-oriented society.

"expensive" disposable catheter
Reuse evaluation
In the Regulations on the Supervision and Administration of Medical Devices issued by the State Council on January 4, 2000 (State Council Order No. 276), special restrictions were imposed on disposable medical devices after use. Article 27 of the Regulations stipulates that: “Medical institutions shall not reuse medical devices that are used at one time; if they have been used, they shall be destroyed and recorded in accordance with relevant state regulations.” Article 43 of the Regulations states: “Violation These Regulations stipulate that if a medical institution reuses a single-use medical device, or if it is destroyed and has not been destroyed, the drug supervision and administration department of the people's government at or above the county level shall order it to make corrections and give a warning, which may be 5,000 yuan or more and less than 30,000 yuan. If the circumstances are serious, the medical institution may impose a fine of not less than 30,000 yuan but not more than 50,000 yuan, and disciplinary action shall be taken against the competent personnel and other directly responsible personnel according to law; if a crime is constituted, criminal responsibility shall be investigated according to law."

During this year's "two sessions", Zhou Youcai, deputy of the National People's Congress and chairman of Heilongjiang Aolida Pharmaceutical Group, once again proposed a proposal to amend the current regulations on medical device supervision, and highlighted the topic of partial disposable medical device reuse. Zhou Youcai said that the state has been advocating the establishment of a conservation-oriented society and achieving a circular economy. However, there is a certain gap between the current medical device supervision laws and regulations and the level of economic development and social needs.

"expensive" disposable catheter
With the rapid development of medical technology, disposable sterile medical device products are used more and more in clinical diagnosis and treatment work.

Disposable medical devices are easy to use, but the increase in medical costs is also increasing. For example, Zhou Youcai, PTCA (percutaneous transluminal coronary angioplasty) is one of the main forms of "coronary interventional therapy." As an important means of treating coronary heart disease, PTCA has been recognized by doctors and patients for its excellent efficacy. At present, in China, including Beijing, Shanghai and other large city hospitals, this treatment requires an average of about 50,000 yuan each time (place a stent). Zhou Youcai told reporters that each additional stent needs to add about 20,000 yuan. "In this expensive treatment cost, only the cost of catheters, stents and other devices account for about 95% of the total medical expenditure."

On September 6, 2007, Zhou Youcai and his team of five top cardiologists, including Professor Hu Dayi of Peking University People's Hospital and Dr. Liu Meilin of Peking University First Hospital, inspected the catheter reuse project of the German VANGUARD Group. Under the active promotion of the German government, the VANGUARD Group mobilized the comprehensive strength and resources of German universities and research institutes, and developed the multiplexing technology and production line of cardiac interventional catheters. More than 1,000 hospitals in Germany and other European countries have fully restored the reuse of cardiac interventional catheters.

According to the report, a hospital with more than 300 beds can directly save medical equipment expenditures of 5 million to 30 million euros annually by reprocessing disposable medical equipment for surgery, cardiology and radiology. “The overall cost of treatment for patients is also reduced by repeated use of medical devices.” Zhou Youcai believes that the successful experience of Germany tells us that some disposable medical devices are absolutely safe and reliable after being processed by professional multiplexing technology. Can be reused. He suggested that the relevant departments should strongly support the reuse of disposable medical devices on the basis of ensuring the safety of reusable devices.

Reuse evaluation
Of course, whether the disposable medical device can be reused is beyond the scope of pure medical behavior, and its safety, feasibility, and economic evaluation have attracted much attention. The Great Wall International Cardiology Conference (referred to as the “Great Wall Association”) is a comprehensive cardiovascular event with multiple fields and multidisciplinary intersections. It is also one of the most grand academic conferences in the current cardiovascular science community in China. The reporter found that at the Great Wall meeting in recent years, there has been more and more discussion about "conduit reuse."

The reporter learned that in recent years, many countries have begun to explore and implement the reuse of disposable medical devices. Among them, the successful experience of German multiplexed conduits has aroused widespread concern in the industry. At the 2006 Great Wall Conference, Professor Ghassemieh Nikou from Germany gave a keynote speech on how to safely implement catheter re-use. Professor Ghassemieh Nikou explained in detail which catheters and guide wires are reusable; the basic conditions for repeated treatment of the instruments; the problems that need to be paid special attention to cleaning and disinfecting PTCA catheters, and how to ensure clinical concerns such as reprocessing quality. Experts told reporters that Germany's reprocessing of multiplexed conduits includes screening, cleaning, disinfection, and testing. The test results show that the used catheter is sterilized by low temperature with 6% ethylene oxide, and the sterilization is thorough, and the performance is safe and reliable. At present, 80% of cardiologists in Germany can use multiplexed catheters professionally, and more than 6 million multiplexed catheters for clinical applications have not received any complaints so far. Experts and government officials from countries such as Denmark and Poland have also given safety evaluations to the multiplexed catheters that are not significantly different from the new catheters.

"In fact, compared with foreign countries, we need to support the reuse of disposable medical devices." Zhou Youcai said that this method of use is particularly in line with the current status of China's medical field. With the advancement of the medical reform process, hospital administrators are increasingly concerned about the social benefits of medical behavior. The implementation of the universal health insurance policy also objectively puts higher demands on the economic efficiency of medical behavior. Hu Dayi and other scholars also said on many occasions that under the strict disinfection measures and scientific reuse process, under the premise that the patient's life safety is fully guaranteed, some medical devices can be reused as clinical experts in intracardiac interventional therapy. The focus of attention of patients and medical device manufacturers.

Looking forward to policy support
However, some people in the industry also suggested that China's medical environment is not conducive to the reuse of disposable medical devices. Therefore, strengthening policy support and coordination has an irreplaceable role. "In China, in terms of repeated use of some disposable medical devices, both technical conditions and production conditions have matured." Zhou Youcai believes that with the guidance and strong support of relevant government departments, the reuse of some disposable medical devices is completely domestic. can be realised. However, he also stressed that how to strengthen the awareness of the reuse of disposable medical devices is an urgent problem to be solved.

During the interview, many experts pointed out that the use of disposable medical devices involves the interests of manufacturers, suppliers, medical units and patients. It is difficult to reach a consensus and suggest that the state solve the problem through legislation. Zhou Youcai, who proposed the proposal twice, used the opportunity of amending the Drug Administration Law to formulate the reuse and disinfection standards by the health department and the food and drug supervision and administration department, formulate strict disinfection measures and scientific reuse treatment procedures, and regulate the cardiac intervention. The catheter multiplexing technology production standard allows the use of cardiac interventional catheter multiplexing devices while ensuring patient safety. This can greatly reduce the economic burden of patients undergoing cardiac interventional surgery, and at the same time enable patients who are subject to economic conditions to be treated, thus reflecting the value of the circular economy. At the same time, the relevant contents of Articles 27 and 43 of the Regulations on the Supervision and Administration of Medical Devices shall be adjusted to allow some disposable medical devices to be recycled and used reasonably.

"Professional normative intervention requires collaboration among multiple medical disciplines." Professor Hu Dayi, the deputy director of the Cardiovascular Branch of the Chinese Medical Association, believes that hospital administrators must integrate cardiology, cardiac surgery, vascular and imaging into a single team. Standardized management. However, he also said that the current problem of interest distribution (manufacturers, departments and doctors, etc.) has affected the standardized management of medical device use. It is recommended that medical institutions take the interests of patients first, and actively deal with the price of expensive equipment in interventional therapy. The medical departments and insurance agencies and other social parties will jointly explore solutions, which will not only benefit the development of the hospital, but also benefit the majority of patients. (China Medical News)

RP International Ltd is top Food Flavourings Supplier and Manufacturer in China.

Flavor or flavour is the sensory impression of food or other substance, and is determined primarily by the chemical senses of taste and smell. They have a long history of safe use in a wide variety of foods, from confectionery and soft drinks to cereals, cakes and yoghurts. They are used in comparatively small amounts.

Our Annual output is 1000mt, including Monosodium Glutamate(MSG), Vanillin, Ethyl Vanillin , Instant Dry Yeast and so on. We have professional product line for different Chemical Food Flavourings. Our products are Kosher, ISO, Haccp, Halal certified with best quality and strict quality control.

With regards to the productions and quality control, We has advanced manufacturing facilities and professional R&D team which providing customers with safe, healthy, hygienic and high-quality products. All the productions are processed strictly in accordance with the regulations of HACCP and ISO system. We also provide value-added services based on customers` personalized requirements in both product application and technical support.

We wholesale and promise the high quality of Food Grade Flavourings with competitive prices, buy Food Additives Flavourings at RP International

Food Flavourings

Food Flavourings,Food Grade Flavourings,Food Additives Flavourings,Flavor Enhancer

RP International Ltd , http://www.rp-foodadditives.com