With the continuous development of packaging skills and the introduction of advanced foreign skills into China, the packaging industry of sterile medical devices in China is also quietly changing. The development of the packaging industry has driven the development of the sterile medical device industry, which has not only eliminated the backward packaging of sterile medical devices in the past, but also promoted the construction of the sterile medical device packaging specification and its system in China, making it continuously improved. This continuously improved regulatory system, in turn, has played a role in standardizing and promoting the development of sterile medical device packaging industry and sterile medical device manufacturing industry, making it continue to develop healthily. The “aseptic inspection” of the device was wrongly regarded as the exclusive method of the review package to adhere to the sterility of the medical device, and the “aseptic inspection” was excessively relied on to control and review the aseptic condition and shelf life of the device. Suzhou medical blister box can not ensure the sterility of sterile medical devices within their shelf life because all parties do not understand the meaning of “sterility assurance level” of sterile medical devices. Backward packaging planning makes the packaging of many sterile products neither suitable for the selected sterilization process nor “sterile access”. Because the aseptic packaging planning is unreasonable, the packaging is not planned as the internationally accepted “peel off” packaging, but as the “tear off” packaging. The medical blister packaging makes it impossible to complete the “aseptic access” of sterile medical devices. For the backward “pull apart” planning, doctors have already polluted the internal devices when they pull open the package to take the devices.
Select unreasonable packaging materials, and lack of knowledge that sterile medical device packaging is an important part of sterile medical devices. Many sterile medical devices that are sterilized with ethylene oxide are packaged with non breathable packaging materials, which is neither suitable for the selected sterilization process nor conducive to the useful release of ethylene oxide after sterilization. The inspection of sterile medical device packaging in manufacturing enterprises in China is relatively weak. Because the experimental methods given in the current specifications in China are destructive, and the nondestructive inspection methods used in the production line are still blank, the inspection of sterile medical device packaging by medical blister box can only be conducted by sampling inspection, instead of online nondestructive full or sampling inspection as in foreign countries, which makes the integrity of sterile medical device packaging less effectively guaranteed. At present, there is no transport experimental method to evaluate whether the packaging system loaded with instruments and sterilized can accept mechanical and physical damage that may occur during storage, transportation and circulation in China’s regulatory system. Because there is no experimental specification that imitates this process, the medical device manufacturer can only prove that the integrity of the medical device packaging at the time of delivery meets the requirements. The heat sealing machine cannot prove whether the sterile packaging of the device can adhere to its due integrity after withstanding the mechanical damage (such as pressure, impact, oscillation, drop and atmospheric pressure, etc.) during the rigorous storage, transfer, transportation and circulation process through recognized experimental methods.
The PP lining plate can not prove whether the sterile packaging of the device can maintain its due integrity after withstanding the severe atmospheric strain (such as the environmental temperature changes repeatedly under extreme conditions such as normal temperature, high temperature and low temperature) during storage, transfer, transportation and circulation by using recognized experimental methods. The establishment of China’s sterile medical device packaging specification system has been highly valued by the national competent department. In the process of establishing this system, it has been widely participated in and strongly supported by domestic and foreign professionals. Just like this, this normative system is relatively perfect. The author believes that with the development of sterile medical device packaging in China, and with the more in-depth discussion of all participants, the standardized system of sterile medical device packaging in China will be increasingly improved, and will certainly play a greater role in the development of sterile medical devices in the future.