Technical Paper on Aseptic Packaging 1 Experience of Aseptic Packaging Standardization
Objective To implement standardized packaging of sterile medical articles and provide quality assurance for clinical use. Methods Organize the staff of the department to seriously study the three specifications of hospital disinfection supply center issued by the Ministry of Health in 2009, so that each staff member can master the packaging standards and skills of standardized aseptic packages and enhance their sense of responsibility in the packaging process. Strict quality inspection must be carried out before the goods are packaged, and the goods that meet the quality requirements can be packaged correctly. Results All the packaged medical devices met the requirements of the quality standard of aseptic materials, and the qualified rate of aseptic materials was 100%. Conclusion Only by paying attention to the packaging of instruments can we provide reliable and safe sterile articles for clinic.
Key words: medical aseptic packaging; Packaging technology; Norms; operate
The hospital disinfection supply room is the department responsible for the cleaning, disinfection, sterilization and sterile supply of all reusable medical instruments, instruments and articles in various departments [1]. The quality of its work is closely related to hospital infection, the occurrence of pyrogen reaction, the harm of particles and the accuracy of pathological specimens, which directly affects the quality of medical care and even the life safety of patients [2]. Standardized operation process is the premise and guarantee of supply room quality [3].
1 staffing
1.65438+
1.2 During the process, one person shall conduct quality inspection and one person shall conduct inspection before packaging.
1.3 packers should be prepared to dress according to the requirements of the specifications, change shoes and wear round hats when entering the inspection and packaging room, and wash their hands (disinfect their hands) or wear gloves before inspecting the packaged items.
2 Preparation of packaging environment
Wipe the workbench and shelves with 0.5% "84" disinfectant before packaging every day, wet mop the floor with 0.5% "84" disinfectant twice a day, wipe the wall with 0.5% "84" disinfectant 1 time every month, and disinfect the air with a medical air purifier twice a day, 1 h/ time; Clean the air conditioning filter regularly to prevent dust, microorganisms, particles and heat source pollution; The indoor temperature is controlled at 20℃ ~ 23℃ and the humidity is 30% ~ 60%. Lighting and ventilation conditions must be good. Sufficient light sources and magnifying glasses with light sources should be installed on the operating table to check whether the quality of cleaning tools meets the requirements, especially the joints and cogging of precision instruments that are difficult to clean. Effective measures to control the bacterial content in the air in the packaging room and strict partition management are important links to control the reduction of bacterial content in the air [4], so clean areas and polluted areas are strictly distinguished, and all kinds of medical devices must be thoroughly cleaned and disinfected in the washing room before being sent to the packaging room. Strictly control the number of people entering the packaging room. Every month, the air in the packaging room, the surface of articles and the hands of staff are cultured with bacteria, and the number of colonies is required to meet the standard and not exceed the Class II standard, so as to effectively ensure the sterilization assurance level of aseptic instruments [5].
3 Preparation of packaging materials
3. 1 Including all cotton fabrics, non-woven fabrics, wrinkled paper, paper-plastic bags, heat sealers, chemical indicator cards, chemical indicator tapes, crawling cards, biological indicator tapes, packaging tapes, CSSD traceability systems, etc.
3.2 Quality Requirements and Inspection of Packaging Materials
3.2. 1 Select the production enterprises that meet the requirements of national health standards and are approved by the national health administrative department.
3.2.2 Packaging materials should be conducive to the penetration of sterilization agents, prevent microbial invasion, and be waterproof, dustproof and tear-resistant. It can maintain the integrity of goods and equipment, and is not affected by pressure, temperature and humidity. It does not produce adhesion and chemical reaction to sterilized articles, which is beneficial to air discharge and steam penetration during sterilization, and can shield bacteria and prevent re-pollution after sterilization.
3.2.3 The cotton cloth is a cotton double-layer plain weave fine cloth, with no seams except four edges; 1 Before use, they were washed at high temperature, degreased and beaten, and the use times were recorded. The cloth should be clean, dry, smooth, light-colored, free from damage and repair, free from blood, stains, hair tips and debris, and free from staining.
3.2.4 The container shall be clean, dry, free of peculiar smell and damage, and the lid shall be tight.
4. Inspection and packaging of reusable medical instruments and instruments
4. 1 Before packaging
4. 1. 1 The quality inspector sets up a microcomputer to print sterilization information according to the name and quantity of the recovered items. Check with the packer * * * whether the product name, category, packer, approver, sterilizer, sterilization pot number, pot number, sterilization date and sterilization validity period on the label are accurate. The validity period of cotton packaging is 7d, the validity period of non-woven fabric and crepe paper double-layer packaging is 6 months, and the validity period of paper-plastic packaging is also 6 months.
4. 1.2 The quality inspector checks the quality of the cleaned and disinfected instruments by visual inspection or a magnifying glass with light source. Check whether the product is clean, free from dirt, rust and blood, and whether the pots, bowls, cans and cups are smooth, free from deformation, holes and water stains. Each utensil is clean, fully functional, flexible in connection, firm in screws and neat and tight in bite, which is suitable for collocation [6]. Containers should be clean and tight, all kinds of conduits should be clean, unobstructed and crack-free, and scissors should be sharp. All kinds of puncture needles should be suitable without rust, hook, bending, cleaning and cracks. If it does not meet the specified quality requirements, it shall be reworked or replaced, and it shall not be bagged, which will affect its use.
4. 1.3 For the assembly of instruments, quality inspectors should carefully count and assemble accurately according to the types and quantities that should be equipped in each package, and sharp instruments should be protected by packages or protective covers. The tip of scissors is equipped with a protective sleeve, and all kinds of puncture needles are separated from the jacket, which is protected by silicone tube. The tracheal cannula is suitable, and both the inner core and the outer jacket are open, so that the tied belt is safe and firm to prevent falling off.
After assembly, if it is found that there are redundant or missing individual instruments that cannot be assembled, it is necessary to find out the reasons immediately to prevent mistakes.
4. 1.4 The quality inspector shall provide treatment towels, hole towels, etc. for the assembled articles. According to the need, put the chemical indicator card into the package; After inspection, the packager selects the appropriate packaging materials for packaging.
4.2 packaging
4.2. 1 Our packaging methods include closed packaging and sealed packaging.
4.2.2 The closed packaging method of surgical instruments consists of two layers of packaging materials, which are packaged twice. According to the requirements, the shaft joint instruments are not completely locked, and the instruments are placed in the order of use. Curved board, therapeutic bowl and cup should not be reversed, and all openings face in one direction. The utensils are separated by absorbent towels or gauze for vapor permeation [7]. The package should be flat and tight, and the sterilization indication mark (with chemical indication mark) should be attached to the upper left corner of the package, and the package should be sealed. The length of the adhesive tape should be suitable for the volume and weight of the package, and the tightness should be moderate. The package should be tightly sealed and kept intact. Similar appliances are packaged and placed vertically in a metal frame, which is convenient for sterilization and loading.
4.2.3 Sealed packaging only uses one layer of packaging material, which is suitable for individually packaged instruments, such as small diagnostic kits, small articles, dressings with low frequency of use, etc. Pay attention to choose a paper-plastic bag with a moderate size when packaging, and leave a space of 3 cm up, down, left and right after the items are put in, so as to prevent the paper-plastic bag from breaking the seal due to too small and too high pressure [8]. The logo is attached to the upper left corner of the plastic surface.
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