Single-use medical devices have problems
Time：
Jan 14,2023
Author：
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Single-use sterile medical devices (hereinafter referred to as sterile devices), refers to sterile, non-pyrogenic, tested and qualified, in the validity period for one-time direct use of medical devices. China's overall number of sterile device manufacturers and the number of per capita use are among the world's leading, and its share in the entire pharmaceutical and medical device industry is considerable. With the further development of the pharmaceutical industry and the increase of people's demand and use of sterile devices, the per capita use rate, group application frequency and quantity of sterile devices in China will also rise rapidly. But the current situation of the use of sterile devices is not optimistic.
1. Sales and purchase channels are more confusing.
Some manufacturers, especially unlicensed manufacturers, in order to avoid taxation and daily supervision, often use personal home delivery, postal delivery and other ways to sell. In order to reduce medical costs, certain medical units, pharmacy business enterprises, individual pharmacies, clinics, village health offices often from the formal channels of purchase. The confusion of the purchase and sale channels, so that a large number of substandard products into the market, so that illegal manufacturers have room to survive, to the legitimate enterprises of production, purchase and sale of impact, disrupting the market order, but also to make the supervision of sterile devices much more difficult.
2. After the use of sterile instruments, failure to carry out effective disinfection, destruction of shape.
Some medical institutions after the use of sterile instruments, can not be effective disinfection, destruction of shape, but arbitrarily discarded, or as garbage sold. There are repeated incidents of children playing with used sterile syringes causing injuries. Sterile instruments are not disinfected, not destroyed, disposed of at will, not only to pollute the environment, become an important source of infection, pollution sources, but also an important source of goods for some unscrupulous enterprises, and then recycling, processing and reuse, and then endanger people's health.
3. Medical institutions, business enterprises are incomplete records of purchases and sales.
In practice, a few medical institutions, business enterprises can not establish a true and complete purchase and sale records, and some even no purchase and sale records, making the purchase and sale of sterile equipment supervision work left a "dead end".
4. The adverse reactions of sterile devices failed to attract sufficient attention.
Sterile devices and drugs, the same will occur adverse reactions, clinical work, many infusion reaction is caused by the infusion device is not qualified. However, influenced by the traditional concept, most health care workers and patients believe that "disposable" is clean, safe and reliable, so the monitoring of adverse reactions of sterile devices has not attracted sufficient attention from the majority of medical personnel and patients.
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