Disposable spinal needles are in direct contact with human tissues, and their sterilization effect is related to patient safety. Different sterilization processes have their own characteristics, and strict processes and controls are required to ensure the sterility and safety of puncture needles.
As an invasive medical device, sterilization of disposable spinal needles is a key link to ensure their safe use. If sterilization is not thorough, it may cause postoperative infection in patients and cause serious complications. Currently, commonly used sterilization processes include ethylene oxide sterilization and radiation sterilization. Each process has its own unique mechanism of action and quality control points. Through scientific and standardized operating procedures, it is ensured that the puncture needles meet the sterility standards.
Ethylene oxide sterilization uses the strong penetration and bactericidal ability of ethylene oxide gas to destroy microbial proteins, nucleic acids and other life substances, thereby achieving the purpose of sterilization. When using this process, the puncture needle must first be pre-cleaned and dried to remove possible stains and moisture on the surface to avoid affecting the sterilization effect. The puncture needle is then placed in a special sterilization bag or container and sent to the sterilizer. The sterilization process requires strict control of parameters such as temperature, humidity, gas concentration and sterilization time. Generally, the temperature is controlled at 37℃ - 63℃, the humidity is maintained at 30% - 80%, the ethylene oxide gas concentration is 450mg/L - 1200mg/L, and the sterilization time varies from 2 to 8 hours according to the characteristics of the product. After the sterilization is completed, it is necessary to go through the analysis process to remove the residual ethylene oxide gas to ensure the safety of the puncture needle. The analysis time is usually 7-14 days. Through forced ventilation or vacuum analysis, the ethylene oxide residue meets the national standard requirements to avoid potential harm to patients.
Radiation sterilization mainly includes gamma ray sterilization and electron beam sterilization. The principle is to use the energy of the ray to destroy the DNA structure of microorganisms, making them lose their ability to reproduce and survive. This sterilization method has the advantages of strong penetration, fast sterilization speed, no need for high temperature and high pressure, and no chemical residue. It is suitable for disposable spinal needles that are sensitive to heat. When implementing radiation sterilization, the radiation dose needs to be precisely controlled. The radiation dose range of general medical devices is 15-25kGy. If the dose is too low, it may not be completely sterilized, and if the dose is too high, it may affect the material properties and physical structure of the puncture needle. At the same time, it is necessary to design a reasonable packaging for the puncture needle, and select packaging materials that can transmit radiation and maintain a sterile barrier, such as medical dialysis paper, composite film, etc., to ensure that microorganisms will not contaminate the puncture needle again during the sterilization process, and that the puncture needle will always remain sterile during the validity period if the packaging is intact.
Regardless of the sterilization process used, product pretreatment before sterilization is crucial. First, the puncture needle must be visually inspected and quality tested to ensure that there are no scratches, deformations and other defects on its surface, and that the sharpness, length, diameter and other parameters of the needle body meet the design requirements. Then, it is cleaned and dried, and impurities such as oil stains and metal debris on the surface are removed by ultrasonic cleaning, high-pressure spraying, etc., and then the puncture needle is dried by hot air or vacuum drying to reach the specified moisture content standard. In addition, the puncture needle needs to be assembled and packaged, and the needle body, needle seat, protective cover and other parts need to be assembled correctly, and sealed with packaging materials that meet the sterilization requirements to provide good basic conditions for the subsequent sterilization process.
To ensure the reliability of the sterilization effect, comprehensive monitoring and verification are required during the sterilization process. Physical monitoring records the temperature, pressure, time and other parameters of the sterilization equipment to confirm whether the sterilization process meets the set requirements; chemical monitoring uses chemical indicator cards, indicator tapes, etc. to visually judge whether the sterilization has achieved the expected effect through color changes; biological monitoring uses biological indicators such as thermophilic Bacillus stearothermophilus, places them in the sterilized items, and cultivates them after sterilization to observe the growth of microorganisms to verify the effectiveness of the sterilization process. At the same time, the performance of the sterilization equipment is regularly confirmed and verified, including empty load verification, full load verification and heat distribution verification, etc., to ensure that the equipment operates stably and the sterilization effect is uniform and reliable. Only when the results of physical, chemical and biological monitoring meet the standards can the sterilization process be judged to be qualified, and the batch of disposable spinal needles can be released for use.
After sterilization, disposable spinal needles are subject to strict quality inspection. In addition to rechecking the integrity and sealing of the packaging, sterility testing is also required. Microbial culture of puncture needles is carried out by membrane filtration method, direct inoculation method and other methods to ensure that they meet the sterility requirements. At the same time, spot checks are carried out on the physical and chemical properties of the puncture needles, such as testing the strength, toughness, pH and other indicators of the needle body to ensure that the sterilization process has no adverse effects on product performance. In addition, a complete traceability management system is established to record the sterilization time, sterilization process parameters, test results and other information of each batch of puncture needles. Once a quality problem occurs, it can be quickly traced back to each link in the production process, and timely measures can be taken to rectify and ensure the safety of patients.
The sterilization process of disposable spinal needles ensures the sterility and safety of puncture needles through scientific principles, strict process control, comprehensive monitoring and verification, and perfect quality inspection and traceability management. With the continuous development of medical technology and the increasing attention paid to medical safety, sterilization processes will continue to improve and innovate, adopt more advanced technologies and equipment, further improve sterilization effects and quality control levels, and provide reliable safety guarantees for clinical medicine.
