Master 20 basic knowledge of medical devices Leave a comment
1. How to distinguish drugs from medical devices containing pharmaceutical ingredients?
(1) For products in which drugs play a major role and medical devices play an auxiliary role (such as syringes preloaded with drugs, etc.), they shall be managed as drugs.
(2) For products in which medical devices play a major role and drugs play an auxiliary role (such as drug-containing stents, catheters with antibacterial coating, drug-containing condoms, drug-containing CONTRACEPTIVE rings, etc.), they shall be managed as medical devices.
(3) Band-aids containing antibacterial and anti-inflammatory drugs should be managed according to drugs.
(4) TCM external application products as traditional TCM external application agents, according to drug management.
2. What is the management system for the production of medical devices in China?
China implements a product registration system for medical devices.
The production of category I medical devices shall be examined and approved by the pharmaceutical supervisory and administrative department of the people’s government of the city divided into districts, and a certificate of production registration shall be issued.
The production of category II medical devices shall be examined and approved by the pharmaceutical supervisory and administrative departments of the people’s governments of provinces, autonomous regions, and municipalities directly under the Central Government, and a certificate of production registration shall be issued.
The production of category III medical devices shall be examined and approved by the pharmaceutical supervisory and administrative department under The State Council and issued with a production registration certificate.
3. What qualifications are required to operate medical devices?
The establishment of a category I medical device distributor shall be filed with the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government for the record. The establishment of category II and Category III medical device trading enterprises shall be conducted through provincial, autonomous regional,
The drug regulatory department of the people’s government of the municipality directly under the Central Government shall examine and approve, and issue a License for Medical device Trading Enterprise. The administrative department for industry and commerce shall not issue a business license without a Medical Device Trading Enterprise License.
4. What are the requirements for medical device advertising?
Advertisements for medical devices shall be examined and approved by the drug regulatory department of the people’s government at or above the provincial level. Without approval, it shall not be published, broadcast, distributed, or posted.
The contents of advertisements for medical devices shall be subject to the instructions for use approved by the drug regulatory department under The State Council or the drug regulatory department of the people’s government of the province, autonomous region, or municipality directly under the Central Government.
5. Do medical devices need to undergo clinical trials before being marketed?
Clinical trials of medical devices are divided into clinical trials and clinical validation.
For medical devices that have not yet appeared on the market and whose safety and effectiveness need to be confirmed, the clinical trial study of medical devices should be carried out before approval of the market.
For medical devices with similar products on the market whose safety and effectiveness need to be further confirmed, a clinical validation study of medical devices shall be conducted before approval of marketing.
6. Which six certificates should be checked when buying medical devices?
(1) Medical Device Manufacturing Enterprise License (Grade II and III medical device manufacturing enterprise);
(2) Medical Device Product Registration Certificate;
(3) Medical Device Business Enterprise License of the business enterprise dealing in the product (refers to the business enterprise dealing in the second and third-class products other than the 13-second class products);
(4) Product certificate;
(5)3C certification certificate (medical devices listed in the “implementation of mandatory product certification product catalog”, there should be 3C certification certificate and logo);
(6)EMC certificate (for medical electrical equipment).
7. Should elderly consumers pay attention to identify the tricks of illegal operators when buying medical devices?
(1) Sweet words, to provide “close to the heart” service for the elderly. Particular way is to send a large number of a salesman, by phone or in the park, market and other distributed public invitation, befriend with the old man first, then invited the old man free to visit the company, also for the old man free shuttle bus, free lunch, etc., on the way to the old man lobby, let a person feel kindness with insistent, And then pretend to be “today, tomorrow without” preferential offer, such as lobbying success, the salesman will strike while the iron is hot, follow the old man home to make money, only cash and multi-dodge not invoiced.
(2) the appearance of “gold”, even openly declared that “legally approved”, “national key support projects”. Illegal operators to obtain the trust of the old man, do not hesitate to rent an office around higher in flourishing the city zone, to the old man how to boast operator’s strength is abundant, approved by the relevant state departments and support, so-and-so leaders have on-the-spot guidance, etc., impressive-looking, all in the name of “legal” to make people believe.
(3) Novelty selling point, play the so-called “green, environmental protection, health, high-tech” banner. Seize the special psychological requirements of the elderly health, the distribution of exquisite publicity and advertising materials, will not have the due function of the product falsely exaggerated into a “cure-all” “panacea”.
8. What points should be considered when choosing medical devices?
The purchase of medical devices should pay attention to the following points: first, vary from person to person, according to the situation. Should be based on his current situation, think about his physical condition (or illness) whether needing a medical instrument? Are drugs or instruments more appropriate? Is this product suitable for your physical condition (or condition)? Is the performance/price ratio reasonable? Combined with their own actual situation will be the above problems in a row so that they will be a more clear understanding of their own products to buy is not what they need. Second, when buying medical devices, you should go to the unit with the production license of medical devices or the business license of medical devices (the products produced or managed should be within the scope approved by the license) to choose and buy. Third, do not listen to advertising at will, to the “free diagnosis” examination results and “recommended on the spot” to your medical equipment curative effect, as well as all kinds of “free health lectures” to screen. When you are not sure whether you need a product, you should consult a doctor, do not buy blindly.
9. What are the contents of medical device instructions?
The specifications of medical devices shall generally include the following contents: product name, model and specification; Name, registered address, production address, contact information, and after-sales service unit of the manufacturer; Number of Medical Device Manufacturing Enterprise License (except category I medical device), number of the medical device registration certificate; Product standard number; Product performance, main structure, the scope of application; Contraindications, precautions and other contents that need a warning or prompt; Interpretation of graphics, symbols, abbreviations and other contents used in medical device labels; Installation and use instructions or diagrams; Product maintenance and maintenance methods, special storage conditions and methods; For products to be used within a time limit, the term of validity shall be indicated; Other contents stipulated in the product standard that should be indicated in the manual.
10. What should not be contained in the instructions of medical devices?
The instructions of medical devices shall not contain the following contents: those containing assertions or guarantees of efficacy such as “best curative effect”, “guaranteed cure”, “comprehensive cure”, “radical cure”, “immediate effect”, “completely non-toxic side effects”; Containing absolutized language and expressions such as “the highest technology”, “the most scientific”, “the most advanced” and “the best”; Indicating the cure rate or effective rate; Compared with the efficacy and safety of products of other enterprises; Contain words of promise such as “insurance by the insurance company” and “invalid refund”; Using the name or image of any unit or individual as proof or recommendation; Contains statements that make people feel that they have suffered from a certain disease, or make people misunderstand that they will suffer from a certain disease or aggravate their illness if they do not use the medical device; Other contents prohibited by laws and regulations.
11. What are disposable sterile medical devices?
Disposable sterile syringe, disposable infusion set, disposable blood infusion set, disposable burette infusion set, disposable sterile injection needle, disposable intravenous infusion needle, disposable plastic blood bag, disposable blood collection device.
How should disposable sterile medical devices be disposed of after use?
Used disposable sterile medical devices must be destroyed after shape, so that their parts no longer have functional, and sterilized harmless treatment.
Can disposable sterile medical devices be reused?
Disposable sterile medical devices should not be reused.
12. From a clinical point of view, what are the categories of instruments and equipment medical devices?
(1) Large equipment, such as CT, MRI, PET/CT, DSA.
(2) Inspection and analysis equipment, such as biochemical analyzer, blood cell counter, double-barrel biological microscope, urine analyzer, enzyme plate meter, washing machine, biological safety cabinet, an ultra-clean workbench.
(3) Diagnostic equipment, such as ultrasonic diagnostic instruments, all kinds of X-ray machines, ECG machines.
(4) Critical first-aid equipment, such as a ventilator, anesthesia machine, and monitor.
13. How to rationally purchase a blood glucose meter?
As a lifelong disease, monitoring and controlling blood glucose is the primary task for patients with diabetes. It is very important to know your blood sugar status in time. In addition, any measures taken by diabetic patients to control blood sugar, such as medication, diet control, and insulin use, can be understood through blood glucose testing. Some patients use urine sugar test paper, although the price is relatively cheap, the urine sugar test paper cannot reflect the situation of hypoglycemia, so it is necessary for patients to equip a blood glucose meter at home.
When buying a blood glucose meter, we must pay attention to the following aspects: Choose a kind of blood glucose meter with good after-sales service and test paper to ensure long-term supply; Different brands of blood glucose meter test paper are different, can not borrow from each other. The best test paper to buy convenient, single piece packaging; Easy to operate, in the purchase of sales staff for you to demonstrate, and confirm that you can operate alone. It is better to have no button so that the operation is easier. The numbers on the monitor should be legible. Ideally, a blood glucose meter that can report measurements by voice. A glucometer should have a “memory” function so that you can store your blood sugar readings.
14. What are the types of blood glucose meters?
The blood glucose meter has been developed since 1968. Clemans has gone through different stages of technological development since its invention. Portable blood glucose meter, dynamic glucose meter, surface glucose meter, and other glucose meters with different principles have emerged. Now, most of our diabetes patients buy portable glucose meters.
According to different working principles, glucose meter can be divided into two kinds: one is electrode type, the other is photoelectric type. Electrode type test principle is more scientific, electrodes hidden in the mouth can avoid pollution, blood samples do not directly contact the machine. Error range in plus or minus 0.2, high accuracy, the normal use of the case, no need for calibration, long life. A photoelectric blood glucose meter is similar to a CD machine. The detection head is exposed and the blood sample is built-in, so it is easy to pollute and affect the test results. The error range is large, and it is generally accurate in a short term.
The blood glucose meter is divided into two types according to different blood collection methods: one is bloodsucking type, the other is wiping blood type. Blood-sucking type blood glucose meter, test paper to control their blood measurement, will not be due to the problem of blood volume deviation results, easy to operate, with test paper point blood drops can be. The blood machine generally collects a large amount of blood, which makes the patient more painful. If the blood is collected more, it will also affect the test results. If the blood volume is insufficient, the operation will fail and the test paper will be wasted. The newest blood glucose meter has adopted the electrode principle, bloodsucking type blood collection.
15. What is the working principle of a CT machine?
The absorption of X-rays varies in various tissues of the body, including normal and abnormal tissues. CT uses this property to divide a selected layer of the body into cubes called voxels. X-ray measures the density or grayscale of each element through the human body, which is the basic unit on a CT image, called a pixel. They are arranged in rows and squares to form an image matrix. When the X-ray tube sends the X-ray beam in one direction through the selected plane, all the voxels arranged along the direction absorb part of the X-ray to a certain extent, making the X-ray attenuation. When the X-ray bundle penetrates the tissue layer (including many voxels) and is received by the opposite detector, the X-ray quantity has been greatly attenuated and is the sum of the attenuation values of all the X rays of the voxels in this direction. Then the X-ray tube rotates a certain Angle and emits the X-ray beam in the other direction, and the detector on the opposite side can measure the sum of all the attenuation values of the X rays along the second irradiation direction. The sum of several X-ray attenuation values can be obtained by scanning the selected layers of tissues repeatedly in different directions in the same way. In the above process, one equation can be obtained for each scan. In this equation, the total amount of X-ray attenuation is known, while the X-ray attenuation value of each voxel forming this total amount is unknown. Scanned for several times, then get a simultaneous equation, through computer arithmetic can solve the simultaneous equations, and the X-ray attenuation value of each one element, then through conversion/a, make each voxel different attenuation values corresponding to the different gray level of each pixel in each pixel matrix which is formed by the image is the level of different density of the black and white image of the organization.
16. What should be paid attention to in the CT examination?
(1) Fasting and water restriction should be carried out 4-6 hours before abdominal, pelvic, and enhanced CT examination to avoid the formation of artifacts and affect the quality of CT images. CT examination of other parts does not require fasting and water restriction.
(2) Because contrast agents can cause allergy, allergy tests should be done before use.
(3) In general, a supine position is taken during the examination. In special cases, a prone position is taken or the position is changed as required. To locate accurately, do not move during the inspection, and 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 equipment in the world, with high scanning speed, high resolution, and excellent image quality. A rapid spiral scan can examine a site in about 15 seconds and detect lesions smaller than a few millimeters, such as small liver cancers, pituitary microadenomas, and small aneurysms. Its function is comprehensive, can carry out all parts of the whole body examination, can be a variety of THREE-DIMENSIONAL imaging, such as multi-layer reconstruction, CT angiography, organ surface reconstruction, and simulation of intestinal, trachea, vascular endoscopy. Ct-guided puncture biopsy can be performed under the real-time lens, which is quick, convenient, and accurate.
18. What are the advantages of MRI?
The images obtained by NUCLEAR magnetic resonance are unusually clear, fine, high resolution, good contrast, and informative, especially for soft tissue layers. So that the doctor directly sees the internal tissue of the human body as clear, clear, greatly improves the efficiency of diagnosis. It avoided many craniotomies, thoracotomy, laparotomy, and other exploratory diagnostic operations that had to be carried out before the operation because of unknown diagnoses so that the patients avoided unnecessary surgical pain and side injury, and complications brought by exploratory surgery. Therefore, it was welcomed by imaging workers and clinicians as soon as it appeared. Now it has been widely used in clinical practice and has become an indispensable examination means for the diagnosis of some diseases.
19. Are CT and MRI superior to B ultrasound?
It isn’t. As an important part of imaging diagnostic technology, ultrasonic diagnostic technology has many advantages over CT and NMR.
First of all, it not only can discover the pathological changes of abdominal viscera, and can coherently, dynamically observe viscera’s movement and function; Lesions can be traced and stereoscopic changes can be displayed, regardless of their imaging stratification. For example, ultrasound is now recognized as the preferred test for biliary tract diseases.
Second, B-ultrasound can monitor the blood flow and direction of organs other than substantive organs (liver, pancreas, spleen, kidney, etc.) with Doppler technology, to identify the nature and degree of organ damage. For example, the doctor can see all kinds of structures inside the heart intuitively and whether there are abnormalities through cardiac color ultrasound.
Third, ultrasound equipment is easy to move, with no trauma, for patients with mobility problems can be diagnosed at the bedside.
Fourth, low price. The cost of an ultrasound examination is generally 35-150 yuan/time, which is 1/10 of CT examination and 1/30 of MRI. This is more affordable for most wage earners. Therefore, “B ultrasound” is often used for a health examination. But does all this mean that “B ultrasound” is superior to CT and MRI in all aspects? Also is not. For example, B-ultrasound is obviously weaker than the latter in terms of clarity and resolution, and it is easy to miss the diagnosis of cavity organ lesions, and the examination results are also susceptible to the influence of the clinical skill level of doctors.
20. How to choose ECG examination?
Electrocardiogram (ECG) is the most commonly used method in the clinical examination of heart disease. But EKG tests have limitations. Not all heart attacks can be diagnosed with a normal ECG. Common electrocardiogram namely we refer to at ordinary times electrocardiogram. The voltage change when it can explain heart activity only and excited the circumstance that spreads, and the disease source that cannot determine heart disease, to pass sex arrhythmia and myocardium is short of blood also discover not easily.
Therefore, it is only suitable for the examination of persistent ECG abnormalities, especially for the diagnosis of cardiac emergencies. An exercise electrocardiogram is to give a patient a certain amount of exercise load (such as stepping ladder, treadle, flat motion) after the electrocardiogram examination. It is a method of examining coronary artery function, which is of great help in the diagnosis of coronary heart disease and valuable in understanding cardiac reserve power.
An ambulatory electrocardiogram is a continuous recording of cardiac activity over a long period of time (24 hours or more). It can fully reflect the symptoms and changes of the heart in the state of activity and sleep. It is suitable for the examination of transient arrhythmia and myocardial ischemia and can diagnose arrhythmia qualitatively and quantitatively and understand cardiac reserve capacity. However, the disadvantage is that it is reported late and cannot be used in cardiac emergencies. Echocardiography is the method that uses the ultrasonic principle to examine cardiac morphology. It is mainly used for the examination and diagnosis of cardiac valvular disease, pericardial effusion, hypertrophic cardiomyopathy, and congenital heart disease.
