Classification, use and importance of quality management of medical devices

Medical devices and supplies play a vital role in the medical field. They are directly or indirectly used in the human body for the purpose of diagnosis, prevention, monitoring, treatment or mitigation of diseases, as well as for the diagnosis, monitoring, treatment, mitigation or functional compensation of injuries. The following is a detailed description of medical devices and supplies:

first, the classification of medical devices.

Medical devices are usually divided into the following three categories according to their risk level and management requirements:

1. class I medical devices the risk level is low, and the implementation of regular management can ensure its safety and effectiveness of medical devices. Such instruments usually include surgical instruments (such as knives, scissors, forceps, forceps, hooks, etc.), scraping plates, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
2. Class II medical devices: Medical devices with moderate risk that require strict control and management to ensure their safety and effectiveness. Such devices include medical suture needles, sphygmomanometers, thermometers, ECG machines, EEG machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, etc. In addition, it also includes some household medical equipment, such as blood glucose meter, band-aid, etc. It is worth noting that some items that look like beauty products, such as contact lenses (soft hydrophilic contact lenses), hyaluronic acid (sodium hyaluronate), etc., also belong to the second category of medical devices.
3. Class III medical devices medical devices that have high risk and require special measures to be strictly controlled and managed to ensure their safety and effectiveness. Such devices typically include implantable cardiac pacemakers, corneal contact lenses, intraocular lenses, ultrasound focused tumor knives, hemodialysis devices, implantable devices, vascular stents, etc. These devices are usually used to support or maintain life and are potentially dangerous to the human body, so their safety and effectiveness must be strictly controlled.

Second, the use of medical devices and supplies.

Medical devices and supplies are used in a wide range of applications, including but not limited to the following:

1. diagnosis, prevention, monitoring, treatment or mitigation of disease this is the most important application area for medical devices and supplies. For example, Sphygmomanometers and thermometers are used to diagnose diseases; Hearing aids and ventilators are used to treat or alleviate diseases.
2. Diagnosis, monitoring, treatment, mitigation or functional compensation of injury some medical devices and supplies can help diagnose injuries, monitor treatment, relieve injury symptoms, or provide functional compensation. For example, orthoses can help restore limb function.
3. Examination, substitution, regulation or support of physiological structures or processes some medical devices and supplies may examine the status of physiological structures or processes, or provide alternative, regulatory, or supportive functions. For example, artificial lenses can replace damaged natural lenses and restore vision.
4. Life support or maintenance in an emergency, some medical devices and supplies can support or sustain life. For example, a defibrillator may provide emergency treatment in the event of cardiac arrest.
5. Pregnancy control some medical devices and supplies are also used for pregnancy control, such as condoms.

Third, the purchase and use of medical equipment and supplies.

When purchasing medical devices and supplies, consumers should go to regular medical institutions and business institutions with relevant qualifications to purchase, and follow the doctor’s advice or use them in accordance with the instructions. At the same time, consumers should also pay attention to the following points:

1. view product qualifications: Ensure that the medical devices and supplies purchased have legal registration certificates or filing certificates.
2. Understanding Product Performance: Before purchasing, you should carefully understand the product’s performance, scope of application, method of use and other information.
3. Pay attention to the validity period of the product: Ensure that the purchased products are used within the validity period.
4. Follow the instructions for use: In the process of use, it should be used in strict accordance with the instructions or doctor’s advice to avoid safety problems caused by improper use.

Fourth, the quality management of medical devices.

The quality management of medical devices is the key to ensure their safety and effectiveness. The State Drug Administration and other relevant departments strictly supervise the production, sales and use of medical devices. At the same time, medical device manufacturers should also establish a sound quality management system to ensure product quality and safety.

However, there are still some medical device companies that have defects in their quality management systems. For example, the recent notice issued by the State Food and Drug Administration shows that the quality management systems of Guizhou Angel Medical Equipment Co., Ltd. and Hubei Xianming Medical Equipment Co., Ltd. have serious defects. These enterprises have identified problems and have been asked to take control measures to order the suspension of production. This reminds us once again that the quality management of medical devices cannot be ignored, and relevant departments and enterprises should work together to ensure the safety and effectiveness of medical devices.

In summary, medical devices and supplies play an important role in the medical field. When purchasing and using, consumers should choose carefully and use correctly; At the same time, relevant departments and enterprises should also strengthen supervision and management to ensure the quality and safety of medical devices and supplies.