How to ensure the sterility of disposable radiofrequency ablation plasma knife (electrode) before use?
Release Time : 2025-01-02
The sterility of disposable radiofrequency ablation plasma knife (electrode) is crucial to the safety of surgery and the health of patients. The following are key measures to ensure its sterility.
First, the sterile environment of the production process is the foundation. During the manufacturing process, production should be carried out in a clean workshop that meets high standards. The air filtration system of the workshop should be able to effectively filter microorganisms and dust particles to achieve a cleanliness standard of 10,000 or even higher. For example, a high-efficiency air filter (HEPA) is used, which can filter out particles larger than 0.3 microns in the air, including bacteria and viruses, to ensure the cleanliness of the production environment and reduce the possibility of microbial contamination from the source.
The selection and design of packaging materials are also very critical. The packaging should use materials that have barrier properties to microorganisms, such as medical-grade plastic films. This material should not only prevent the entry of external microorganisms, but also be able to withstand certain physical and chemical environmental changes. The sealing method of the packaging is equally important. Heat sealing or ultrasonic sealing technology is used to ensure that the edges of the packaging are sealed intact, without tiny gaps, to avoid the invasion of microorganisms.
Sterilization is the core step to ensure sterility. Common sterilization methods include ethylene oxide sterilization or gamma ray sterilization. Ethylene oxide sterilization can penetrate the packaging materials and the inside of the device and effectively kill various microorganisms. During the sterilization process, the sterilization parameters, such as the concentration, temperature, humidity and sterilization time of ethylene oxide, must be strictly controlled to ensure the consistency and reliability of the sterilization effect. Gamma ray sterilization achieves the purpose of sterilization by destroying the DNA structure of microorganisms through high-energy rays. This method does not require chemical reagents and will not leave harmful substances, but requires precise control of the radiation dose.
Quality inspection is indispensable. After sterilization, sampling and testing of packaging integrity and sterility are required. Through microbial culture tests, check whether there is microbial growth in the package to determine whether the sterilization is successful. At the same time, non-destructive testing technology is used to check whether the package has minor damage to ensure that each plasma knife (electrode) meets the sterility standard before leaving the factory.
The transportation and storage processes also need to be strictly controlled. Products should be stored in a dry, cool and well-ventilated environment, avoiding direct sunlight and high temperature and humidity. During transportation, the packaging should be protected from physical damage such as squeezing and collision to maintain the integrity of the packaging.
The operation of medical staff before use is also critical. When opening the package, it should be done in a clean and sterile operating environment, such as on the sterile operating table in the operating room, and strictly follow the operating procedures to avoid the introduction of microorganisms due to improper operation.
Finally, a complete traceability system should be established to record the production, sterilization, transportation, storage and use of each batch of products. Once a sterility problem occurs, the cause can be traced in time and corresponding measures can be taken to ensure the sterility of the disposable radiofrequency ablation plasma knife (electrode) until it is used.