1. How to distinguish between medicines medical devices containing pharmaceutical ingredients?

(1) For products that have a primary role of drugs medical devices have ancillary drugs (such as syringes pre-loaded with drugs, etc.), they are managed as drugs.

(2) For products with medical devices as the main function drugs as auxiliary functions (such as drug-containing stents, catheters with antibacterial coatings, drug-containing condoms, drug-containing birth control rings, etc.), they are managed as medical devices.

(3) Bandages containing antibacterial anti-inflammatory drugs are managed according to drugs.

(4) Traditional Chinese medicine external application products, as traditional Chinese medicine external application, are managed according to drugs.

2. What kind of management system does China implement for the production of medical device products?

China implements a product production registration system for medical devices.

The production of first-class medical devices shall be reviewed approved by the drug supervision administration department of the district-level municipal people's government issued with a product production registration certificate.

The production of the second category of medical devices shall be reviewed approved by the drug supervision administration department of the people's government of the province, autonomous region, municipality directly under the Central Government, a product production registration certificate shall be issued.

The production of the third category of medical devices shall be reviewed approved by the drug regulatory department under the State Council issued with a product production registration certificate.

3. What qualifications are required to operate medical device products?

The establishment of a first-class medical device operating enterprise shall be filed with the drug regulatory department of the people's government of the province, autonomous region municipality directly under the Central Government. The establishment of the second third types of medical device operation enterprises shall be conducted through the province, autonomous region,

The drug supervision administration department of the people's government of the municipality directly under the Central Government shall review approve it issue it with a "License for Medical Device Operation Enterprise". Without the "Medical Device Operation Enterprise License", the administrative department for industry commerce shall issue a business license.

4. What requirements should medical device advertisements meet?

Medical device advertisements should be reviewed approved by the drug regulatory department of the people's government at above the provincial level; without approval, they shall be published, broadcast, distributed posted.

The content of the medical device advertisement shall be subject to the instruction manual approved by the drug regulatory department of the State Council the drug regulatory department of the people's government of the province, autonomous region municipality directly under the Central Government.

5. Do medical devices need to undergo clinical trials before going to market?

Medical device clinical trials are divided into medical device clinical trials medical device clinical trials.

For medical devices that have yet appeared on the market whose safety effectiveness have yet to be confirmed, clinical trial studies of medical devices are required before approval for marketing.

For medical devices whose similar products have already been marketed whose safety effectiveness need to be further confirmed, clinical verification studies of medical devices are required before approval for marketing.

6. Which six certificates should be checked when purchasing medical device products?

(1) "Medical Device Manufacturing Enterprise License" (Class II Class III Medical Device Manufacturing Enterprises);

(2) "Medical Device Product Registration Certificate";

(3) The "Medical Device Operation Enterprise License" of the operating enterprise operating the product (refers to the operating enterprises of the second third category products other than the 13 second category products);

(4) Product certificate;

(5) 3C certification (all medical devices equipment listed in the "Product Catalog for Compulsory Product Certification" should have a 3C certification logo);

(6) EMC certificate (referring to medical electrical equipment).

7. Elderly consumers should pay attention to identifying the tricks of illegal operators when purchasing medical devices?

(1) Sweet words sweet words, providing a "personal attack" service for the elderly. The specific method is to send a large number of salespersons send invitation letters by calling in various public places such as parks markets. They first get close to the elderly, then enthusiastically invite the elderly to visit the company for free, prepare free shuttle buses free lunches for the elderly On the way, he continued to lobby the elderly, which made people feel uncomfortable, then pretended to offer a preferential offer of "Today, Tomorrow." Multi-party dodges do invoice.

(2) The facade is “gold-covered”, even publicly declares that it is “legally approved” “national key support project”. In order to defraud the trust of the elderly, the unscrupulous operators spared no expense in renting higher-grade office buildings in the bustling area of the city, boasted to the elderly how powerful the operators were, how to obtain approval support relevant state departments, that certain leaders had visited in person, The sounding banner of "legitimate" convinced people.

(3) The selling point is novel, the so-called "green, environmental protection, health, high-tech" banner. Seize the old people's special psychological requirements for health, distribute exquisite publicity advertising materials, falsely exaggerating products that do have the functions they should have into "a panacea" for "all diseases".

8. What issues should be considered when purchasing medical devices?

Pay attention to the following points when purchasing medical equipment: First, it varies person to person, according to the time. According to your current situation, think about whether you need a medical device for your physical condition ( condition)? Is it more appropriate to use drugs equipment? Is the product in front of you suitable for your physical condition ( condition)? Product performance Is the price ratio reasonable? In line with your actual situation, the above problems will be lined up, so that you will more clearly understand whether the product you want to buy is what you need. Second, when purchasing medical devices, they should go to a unit that has a medical device production license a medical device operation license (the products they produce operate should be within the scope of the license verification). The third is to listen to advertisements at will, but to screen the results of the "free clinic" the effectiveness of the medical devices recommended to you on the spot, as well as various "free health lectures". When you are sure whether you need a certain product, you should consult a doctor never buy blindly.

9. What are the contents of the medical device instructions?

The medical device specification should generally include the following: product name, model, specifications; manufacturer name, registered address, production address, contact information after-sales service unit; the number of "Medical Device Manufacturing Enterprise License" (except for first-class medical devices), Medical device registration certificate number; product standard number; product performance, main structure, scope of application; contraindications, precautions, other content that requires warnings prompts; interpretation of graphics, symbols, abbreviations, etc. used in medical device labels; installation instructions for use illustrations; product maintenance maintenance methods, special storage conditions, methods; products that are used within a specified period of time should be marked with an expiration date; other content specified in the product standard that should be indicated in the manual.

10. What should be included in the instructions for medical devices?

The medical device instructions shall contain the following contents: Contains “assuming the most effective”, “guaranteed cure”, “package cure”, “radical cure”, “immediate effect”, “completely non-toxic side effects” other assertions guarantees indicating efficacy; contains “ The most technical "," most scientific "," advanced ", other sterilized languages expressions; those that indicate the cure rate efficiency; compared with the efficacy safety of other enterprise products; contain" insurance company insurance "," Promising language such as "invalid refund"; using the name image of any unit individual as a proof recommendation; contains a person who feels that he has suffered a certain disease, makes him misunderstand that he will suffer a certain disease if he does use the medical device The expression that aggravates the disease; other contents prohibited by laws regulations.

11. What are the single-use sterile medical device products?

Disposable sterile syringes, disposable infusion sets,

Disposable blood transfusion set, disposable burette infusion set, disposable sterile injection needle, disposable intravenous infusion needle, disposable plastic blood bag, disposable blood collection device.

What should I do with disposable sterile medical devices after use?

The used disposable sterile medical devices must be destroyed after destruction, so that their parts no longer have the function of use, should be disinfected harmless.

Can disposable medical devices be reused?

Disposable sterile medical devices cannot be reused.

12. a clinical perspective, what types of medical equipment can be divided into categories?

(1) Large-scale equipment, such as: CT, MRI, PET / CT, DSA.

(2) Inspection analysis equipment, such as: biochemical analyzer, blood cell counter, binocular biological microscope, urine analyzer, microplate reader, plate washer, biological safety cabinet, ultra-clean workbench.

(3) Diagnostic equipment, such as: ultrasonic diagnostic equipment, various X-ray machines, electrocardiogram machines.

(4) Severe emergency equipment, such as ventilator, anesthesia machine, monitor.

13. How to buy a blood glucose meter rationally?

Diabetes is a lifelong disease. Monitoring controlling blood sugar is the primary task of diabetics. It is very important to know your blood sugar in time. In addition, any measures taken by diabetics to control blood sugar, such as medication, diet control, use of insulin, understanding of the results of use, must also be tested by blood sugar to be aware. Some patients use urine test strips. Although the price is cheaper, urine test strips do reflect hypoglycemia, so it is necessary for patients to have a blood glucose meter at home.

When buying a blood glucose meter, you must pay attention to the following aspects: choose a blood glucose meter with good after-sales service test strips to ensure long-term supply; different brands of blood glucose meters have different test strips cannot be borrowed each other. The test strips are easy to purchase, single-piece packaging; easy to operate, the sales staff is required to demonstrate for you at the time of purchase, confirm that you can operate separately. No keys, making operation easier. The number displayed on the display of the blood glucose meter should be easily recognizable. It is a blood glucose meter that can report the measured value by voice. The blood glucose meter has a "memory" function in order to store the blood glucose value you measure.

14. What are the types of blood glucose meters?

The blood glucose meter has been invented by Tom Claymans in 1968. It has gone through different stages of technological development, there have been blood glucose meters with different principles such as portable blood glucose meters, dynamic blood glucose meters, meter blood glucose meters. Now our diabetes Most patients buy portable blood glucose meters.

Blood glucose meters can be divided into two types according to different working principles: one is electrode type the other is photoelectric type. The electrode type test principle is more scientific. The electrode is hidden in the mouth to avoid contamination, the blood sample does directly contact the machine. The error range is plus minus 0.2, the accuracy is high. Under normal use, no calibration is required the life is long. The photoelectric blood glucose meter is similar to a CD player. The probe is exposed. The blood sample is built-in. It is easily contaminated affects the test results. The error range is relatively large. Generally, it is relatively accurate in a short period of time.

Blood glucose meters are divided into two types according to different blood collection methods: one is the blood-sucking type the other is the blood-sucking type. Blood-suction type blood glucose meter, the test paper controls the blood sample measurement by itself, there will be no result deviation due to the blood volume problem, the operation is convenient, just use the test paper to click on the blood drop. Blood-smearing machines generally have a large blood collection volume, patients suffer more. If more blood is collected, the test results will be affected. If the blood volume is insufficient, the operation will fail the test paper will be wasted. The new blood glucose meters have adopted the principle of electrodes, blood-sucking blood collection.

15. What is the working principle of CT machine?

Various tissues of the body (including normal abnormal tissues) absorb X-rays differently. CT uses this feature to divide a selected layer of the human body into many cube cubes. These cube cubes are called voxels. X-rays measure the density grayscale of each voxel through the human body, which is the basic unit on the CT image, called pixels. They are arranged in a square matrix to form an image matrix. When the X-ray tube emits an X-ray beam one direction through the selected layer, each voxel arranged in this direction absorbs a part of the X-ray to a certain extent, causing the X-ray to attenuate. When the X-ray beam penetrates the tissue level (including many voxels) is received by the opposite detector, the amount of X-rays has been attenuated a lot, which is the sum of the X-ray attenuation values of all voxels in this direction. Then the X-ray tube rotates by a certain angle, then emits the X-ray beam in the other direction, then the detector on the opposite side can measure the sum of the X-ray attenuation values of all voxels in the second irradiation direction. X-ray scan of the selected layer of tissue in different directions can get the sum of several X-ray attenuation values. In the above process, each scan can get an equation. The total amount of X-ray attenuation in this equation is a known value, the X-ray attenuation value of each voxel forming this total amount is an unknown value. After several scans, a simultaneous equation can be obtained. This simultaneous equation can be solved by computer operation, the X-ray attenuation value of each voxel is obtained, then subjected to digital / analog conversion to make each voxel different The attenuation value forms different gray levels of the corresponding pixels, the matrix image formed by each pixel is a black--white image with different densities organized at this level.

16. What should be paid attention to when doing CT examination?

(1) Abdominal, pelvic intensified contrast CT examinations must be fasted watered 4-6 hours ago to avoid the formation of artifacts affect the quality of CT images. CT examination of other parts does need to fast water.

(2) Because contrast agents can cause allergies, an allergy test is required before use.

(3) Generally, the supine position is taken during the examination, the prone position is taken in special cases the posture is changed as required. In order to locate accurately, do disturb during the inspection, cooperate with the staff to complete the inspection.

17. What are the advantages of spiral CT?

Spiral CT machine is one of the most advanced CT equipments in the world. It has fast scanning speed, high resolution excellent image quality. A fast spiral scan can check a part in about 15 seconds, can find lesions less than a few millimeters, such as small liver cancer, pituitary microadenoma, small aneurysm. It has comprehensive functions can perform various examinations of the whole body. A variety of three-dimensional imaging is possible, such as multi-level reconstruction, CT angiography, organ surface reconstruction, simulated intestinal, tracheal, vascular endoscopy. It can perform CT guided puncture biopsy under real-time lens, which is fast, convenient accurate.

18. What are the advantages of MRI?

The images obtained by MRI are exceptionally clear, fine, high resolution, good contrast, large amount of information, especially for soft tissue levels. It makes the doctor as clear clear as directly seeing the internal tissues of the human body, greatly improving the diagnosis efficiency. It avoids many craniotomy, thoracotomy, laparotomy, other exploratory diagnostic operations that had to be performed because of the unknown diagnosis before surgery, so that the patient avoids unnecessary surgical pain the side effects caused by exploratory surgery. Injuries complications. Therefore, it has been welcomed by imaging workers clinicians as soon as it appeared, it has been widely used in clinics at present, has become an indispensable inspection method for the diagnosis of some diseases.

19. Are CT MRI better than B ultrasound?

No. As an important part of imaging diagnosis technology, ultrasound diagnosis technology has many advantages over CT MRI.

First of all, it can only detect the lesions of the abdominal organs, but also observe the movement function of the organs continuously dynamically; it can track the lesions show the three-dimensional changes without being restricted by its imaging stratification. For example, at present, ultrasound examination has been recognized as the primary examination method for diseases of the biliary system.

Second, B-ultrasound can also use Doppler technology to monitor blood flow direction for organs other than solid organs (liver, pancreas, spleen, kidney, etc.), so as to identify the nature degree of organ damage. For example, the doctor can intuitively see the various structures in the heart whether there are abnormalities through the color Doppler ultrasound.

Third, the ultrasound equipment is easy to move has no trauma, can be diagnosed by the bedside for patients with limited mobility.

Fourth, the price is low. The cost of ultrasound examination is generally 35-150 yuan / time, which is 1/10 of CT examination 1/30 of MRI. This is for most