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Shanghai Drug Administration released 123 active recall information on medical devices
Hits:5776 Putdate:2018-07-13

 In order to strengthen the supervision and management of medical instruments, control the defective medical equipment products, eliminate the hidden dangers of medical instruments and ensure the safety and effectiveness of medical instruments, the State Administration of food and Drug Administration announced the newly revised "measures for the management of medical instruments recall" (hereinafter referred to as the "method") in January 25, 2017. In the "measures", it is clear that the medical instrument production enterprise is the main body of responsibility for the quality and safety of the medical instruments it produces. It should establish and improve the management system of the recall of medical instruments according to the regulations of the "measures", collect the relevant information on the safety of medical instruments, adjust the possible defective products, and recall the defective products in time.

In the first half of 2017, Shanghai food and Drug Administration issued 123 active recall information for medical device enterprises. According to the product category, 61 active class products, 34 passive products and 28 extracorporeal diagnostic reagents. According to the severity of product defects, 10, 59 and three recall were recalled at the first level.
An analysis of the reasons for the initiative recall of medical equipment enterprises
Through the analysis of the active recall of medical instruments in the first half of 2017, the main reasons for the initiative recall are the defects of product design, the control of production process, and the error of label marking. The recall of product design defects accounts for about 54% of the total. There are more recalls caused by product design defects in active equipment medical devices, accounting for about 58% of the total. There are a number of product failures caused by product software defects, and the recall events caused by the production process control problem account for about 24% of the total. For example, the production process control problem is about 24% of the total. Abnormal raw materials, resulting in product risk, product packaging bags are not sealed, resulting in packaging bags sterile barrier damage.
Two, active recall event risk hints
According to the summary of the first half of 2017 medical equipment recalls, the risk of medical apparatus and operation and use should be improved.
First, focus on the risks caused by embedded software failures of active medical devices. Active medical devices are relative to passive medical devices. They refer to medical instruments that rely on electrical energy or other energy, rather than directly from the human body or the energy produced by gravity. The software components of active medical devices play a medical role by controlling or driving the hardware of medical devices. In the first half of 2017, in the first half of the medical device recall, some medical devices were found to be due to the unintended early warning or response caused by the failure of the software components, suggesting the risk caused by the failure of the software components of the active medical devices.
Two is to focus on the risk of sterilized medical devices due to product sealing damage. The packaging of aseptic medical instruments is essential to maintain the aseptic state of medical instruments. The aseptic barrier system formed through product packaging is the guarantee of the aseptic state after the medical instruments are listed. In the first half of 2017, the active recall of medical devices found that some medical devices were damaged due to sealing problems and so on.
The three is to focus on the risks that label identification errors may cause. In the first half of 2017, in the first half of the medical equipment recall, some enterprises found that the product label was lack of production date, registration card information error, label misplaced as other products and so on.
At present, the relevant medical device enterprises have investigated and evaluated possible defective products, and adopted corresponding corrective and preventive measures.
 
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