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Sterile medical devices refer to the medical devices which are produced and sterilized by the manufacturer and supplied in a sterile state, and are directly used by the medical unit without further sterilization. It includes: disposable sterile medical devices and implantable sterile medical devices. From the rural primary medical units to the top three central hospitals in big cities, aseptic devices are widely used in the prevention, diagnosis and treatment of diseases. They are the most widely used medical devices with the most contact with patients and play a very important role in China's medical and health security. Therefore, no matter what causes the product safety and quality accidents, its wide coverage, great harm and long-term social impact are incomparable to any other medical devices.
For the medical industry, Hai is a very serious and important topic. Hai is the abbreviation of healthcare associated infections, which refers to medical-related infections, and it is related to many factors. The infection caused by medical devices used in medical operation accounts for about two-thirds of all infections. Aseptic medical device packaging is the first line of defense to protect medical devices and prevent infection. Packaging failure will threaten the health and life of patients and medical staff. This paper discusses the importance and Prospect of sterile medical packaging barrier system for medical devices and Hai from the following points.
The international standard of aseptic medical packaging and the development of Chinese standard Looking back on history, as early as the 1970s, medical device manufacturers have begun to seek packaging to ensure the safety and efficacy of sterile products, while reducing waste in hospitals and supply chains, and providing cost-effectiveness for medical reform. Safety has become a basic quality. In the development of these years, the focus of work has been to improve the safety of the whole sterile barrier medical device packaging industry. In the practice of medical packaging engineering, it involves such aspects as physical properties, sterile barrier performance, stability of aging packaging, easy opening, and material cleanliness. A lot of effective work of scientists and engineers makes today's packaging more and more solid, more functional and cheaper. Aseptic barrier packaging is an integral part of a comprehensive and effective medical delivery system. However, from the data of Hai that is not optimistic, we still see that there is still a lot of room for improvement. This requires unified action of the industry, laws and regulations to ensure the safety and effectiveness of medical products.
Before 1993, there were many standards and regulations, which were not perfect. The 1993 European medical device directives is a milestone. The regulation has accelerated the significant change of medical equipment packaging industry, and the Certification Department has started the work of certification packaging. The introduction of the scheme and the early work effectively promoted the birth of iso11607, the packaging standard for final sterilized medical devices, and the cen packaging standard officially issued in 1997. Since then, iso11607 has evolved into the main global standard to guide the packaging operation of medical devices .
Iso11607 helps to standardize the industry standard, because it is a separate standard; this standard not only helps the unified management of all medical device manufacturers (MDMS), but also effectively reduces the emergence of non-standard interpretation of standards by certification organizations.
As a continuation of packaging standards, in 1996, the U.S. Food and Drug Administration (hereinafter referred to as FDA) issued its "quality system specification" (i.e. "QS regulatory system"), which introduced the concept of design control. The enforcement result of this specification is that packaging must be considered in the process of design control. These standards are independent and related to each other, effectively ensuring the consistency, operability and certification of medical packaging. With the release of these standards, aseptic packaging laws and regulations have made great progress.
Iso11607:2006 packaging of terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems and Part 2: requirements for validation of forming, sealing and assembly processes are international standards for sterile medical packaging. Iso11607 is a milestone document, which is more significant now. In China, iso11607:2003 "packaging of final sterilization medical devices" has been adopted equally, which has been transformed into national standard, and GB / t19633-2005 "packaging of final sterilization medical devices" was issued on January 24, 2005, which was implemented on May 1, 2005.
Factors affecting the selection and design of aseptic medical packaging materials The functions of aseptic medical packaging mainly include: (1) Provide microbial barrier and physical protection (2) Must be suitable for sterilization (3) Keep sterility and integrity until it is used (4) Easy to open and aseptic delivery (5) Identify products, clearly indicate information and warnings For the sterile medical device manufacturing industry, the commonly used sterilization packaging materials are porous materials (i.e. breathable materials, such as paper, teweiqiang?) and impermeable materials (such as plastic film, etc.). The commonly used packaging forms (sterile barrier system) are: hard blister box, soft blister box (FFS packaging), sterilization tube bag