1. In recent years, with the development of the medical device industry and people's increasing demand for health, the safety and effectiveness of medical devices have attracted more and more attention. So what is a medical device?
Answer: According to the current Regulations on the Supervision and Administration of Medical Devices, medical devices refer to instruments, equipment, appliances, in vitro diagnostic reagents and calibrators, materials and other similar or related items that are directly or indirectly used on the human body, including all The required computer software; its utility is mainly obtained through physical methods, not through pharmacology, immunology or metabolism, or although these methods are involved but only play an auxiliary role; its purpose is:
(1) Diagnosis, prevention, monitoring, treatment or alleviation of diseases;
(2) Diagnosis, monitoring, treatment, mitigation or functional compensation of injury;
(3) Inspection, substitution, adjustment or support of physiological structure or physiological process;
(4) Life support or maintenance;
(5) Pregnancy control;
(6) Provide information for medical or diagnostic purposes by examining samples from the human body.
Elements to determine whether it is a medical device:
Device use-human body
Device category-instruments, equipment, appliances, materials, software, other
Device form---single or combined use
Device purpose---diagnosis, prevention, monitoring, treatment or alleviation of disease damage (function compensation: dentures, orthotics); inspection, replacement, adjustment or support of physiological structures or physiological processes; life support or maintenance (ventilators, Sputum suction machine, cardiopulmonary resuscitation machine, kidney dialysis machine, intensive care unit, atrial defibrillator); pregnancy control; examination of human samples to provide information for medical or diagnostic purposes
Mode of action---Utilities are mainly obtained through physical methods, not through pharmacology, immunology, or metabolism, or although these methods are involved but only play an auxiliary role
2. How does my country manage medical device products?
Answer: At present, my country, like most countries, implements classified management of medical device products according to the degree of risk. Generally, the risks of medical devices are evaluated by comprehensively considering factors such as the intended purpose, structural characteristics, and use methods of medical devices, and medical devices are divided into three categories according to the degree of risk.
The first category refers to products that have a low degree of risk and can be guaranteed to be safe and effective through routine management. Such as: surgical instruments (knives, scissors, forceps, tweezers, hooks), scrapers, medical X-ray films, surgical gowns, surgical caps, examination gloves, gauze bandages, drainage bags, etc.
The second category is medical devices that have moderate risks and require strict control and management to ensure their safety and effectiveness. Such as: medical suture needles, sphygmomanometers, thermometers, electrocardiographs, EEG machines, microscopes, acupuncture needles, biochemical analysis systems, hearing aids, ultrasonic disinfection equipment, non-absorbable sutures, condoms, etc.
The third category is medical devices that have higher risks and require special measures to strictly control and manage them to ensure their safety and effectiveness. Such as: implantable cardiac pacemakers, contact lenses, intraocular lenses, ultrasound tumor focusing knives, hemodialysis devices, implant equipment, vascular stents, comprehensive anesthesia machines, dental implant materials, medical absorbable sutures, blood vessels Internal catheter, etc.
In recent years, the province’s drug regulatory system has adhered to the problem-oriented and risk management principles, focusing on varieties and risks, and adopted various forms such as licensing inspections, routine inspections, unannounced inspections, cause-related inspections, follow-up inspections, and special inspections to strengthen medical devices. Supervision has ensured the safety of the people in using weapons.
3. How to properly store and maintain medical devices?
Answer: Generally speaking, the product storage, maintenance and maintenance methods are marked on the medical device instructions, and special instructions are also given for medical devices with special storage conditions or methods. As long as it is done in accordance with the requirements of the instructions, the medical devices can be properly stored and maintained. In addition, the following issues should be paid attention to when storing medical devices at home:
(1) For medical devices that have a service life, pay attention to use them within the validity period.
(2) Pay attention to whether the packaging is sterile. For medical devices with sterile packaging, pay special attention not to damage the packaging. If the packaging is damaged, do not use it again.
(3) Do not reuse single-use instruments.
(4) Some medical devices are fragile and should be kept properly to prevent shattering.
(5) Household medical devices that can be used for a long time need to be maintained regularly or irregularly. It is necessary to find a manufacturer or a special formal service organization to guide and provide specific services.