What is a sterile medical device? Sterile medical devic […]
What is a sterile medical device?
Sterile medical devices refer to products that have no living microorganisms. They are medical device products provided by medical device manufacturers in a sterile state. They are sterile medical device products that are directly used by medical institutions and the public without sterilization.
What are the characteristics of sterile medical devices?
At present, the state supervises and manages sterile medical devices in accordance with regulations. All units or individuals engaged in the production, operation, use, supervision and management of sterile equipment should establish a quality management system, form a document, implement it and maintain its effectiveness according to the characteristics of the product and the requirements of the measures. As an integral part of the quality management system, risk management should be implemented throughout the product's life cycle.
What are the sterilization requirements for sterile medical devices?
Sterile medical device manufacturing enterprises establish different levels of clean production environments in accordance with the requirements of management specifications. Strict control is required in terms of raw materials, production processes, personnel hygiene, equipment cleanliness, materials, and human flow, so that microbial contamination is controlled to the standards specified in the standard. Acceptable level.
Sterilization is the physical and chemical killing of all living microorganisms (including pathogenic and non-pathogenic microorganisms, breeding or spore-type microorganisms). The sterility of sterile medical devices is not absolute, it only reduces the probability of microbial survival to a minimum. The current standard for sterilization probability of sterile medical devices is 10-6, which is one in one million. Common sterilization methods for medical devices include moist heat sterilization, radiation sterilization, and ethylene oxide sterilization. The sterilization requirements should comply with the corresponding national standards.
What precautions should be taken when using sterile medical devices?
Disposable products are not allowed to be reused. The used sterile instruments must be destroyed in accordance with regulations so that their parts and components no longer have the function of use, disinfected and harmlessly treated, and records must be made. Sterile products are sterilized and must be used within the expiration date. If the single package is damaged and the sheath is detached, it is forbidden to use and scrapped. The use of products must strictly follow aseptic technical procedures. The product should be stored in a ventilated, dry room with a relative humidity of less than 80%.