The New Deal landed, the number of recalls of medical equipment companies doubled

In the first quarter of April 11th, the Shanghai Food and Drug Administration issued a total of 63 medical device companies to voluntarily recall information. According to product categories, 38 active products and 17 passive products, in vitro diagnostic reagents 8 products; According to the severity of product defects, 1 item of the first recall (published by the General Administration of Directorate), 19 items of the second grade recall, 44 items of the third grade recall.

The number of voluntary recalls released in the first quarter has increased by 110% compared to the same period last year. The analysis of the reasons is as follows. First, supervision of product defects discovered during random inspections and flight inspections has triggered voluntary recalls. medical instruments Supervised sampling inspections, flight inspections and active recalls were effectively linked, and preliminary regulatory cooperation was formed. Second, active recalls of domestically-produced medical devices increased. In the first quarter, five domestic medical device products were voluntarily recalled.

The recall of medical devices is an important means to control defective medical device products and eliminate potential safety hazards of medical devices. The increase in the number of voluntary recall reports reflects the production and operation of medical devices in the city. enterprise The overall level of quality management and risk management awareness have been continuously improved.

(I) Analysis of Recall Reason

In the first quarter, the main reasons for the voluntary recall were product design defects, production process control problems, and labeling errors. The recall incidents caused by product design defects accounted for about 46% of the total. Product failure caused by product software defects accounted for several reasons. The majority of recalls caused by defects in the control of production processes account for approximately 33% of the total number, for example: raw material control defects, assembly errors, etc.

(II) Risk Warning

The first is to pay attention to the risk of blood glucose test strips. The first recall of the blood glucose test strips this quarter was due to the fact that the glucose test strips (enzymatic methods) affected the assay results due to low enzyme levels, which in turn affected patient medications, especially Pregnant women The effect of medication errors on the fetus.

Second, attention is paid to the risk of software failures in active equipment products. Active device recalls accounted for 60% of the total in this quarter. Among them, the recall focused on software causes, prompting medical device operators to pay close attention to the launch of the production enterprise. Software upgrades and other information.

Third, attention was paid to the deviation of detection results caused by external interferences of in vitro diagnostic reagent products. In the quarterly recall of in vitro diagnostic reagent products, there were three cases of deviations due to unanticipated external interferences such as drugs and biotin.

The first is to publish and publicize the “Regulations on Medical Device Recall Management.” To strengthen the supervision and coordination of medical device recalls in this Municipality and rationalize the responsibilities of various departments, the Bureau issued the “Shanghai Medical Device Recall Management Work” on January 15, 2018. The "Regulation" (trial), and conducted to various relevant regulatory agencies.

The second is to initiate the supervision and inspection after the active recall of information.

The third is to launch an online direct supervision and supervision platform for the active recall of medical devices. Our Bureau plans to initiate the establishment of medical devices to voluntarily recall the online direct reporting system. The establishment of the system will facilitate the enterprises to apply online and facilitate the sharing of information among regulatory agencies, forming a regulatory collaboration. .

In terms of service innovation and development, the SIPO will continue to increase the 'throttle' to loosen up the development of the medical device industry and stimulate innovation. At the same time, it will establish a risk prevention 'brakes' mechanism, strengthen post-event supervision, and implement corporate adverse event monitoring and defects. Responsibility for product recalls: Encourage companies to proactively monitor adverse events, recall defective products, raise awareness of corporate risk prevention, and impose strictest penalties on companies that do not voluntarily recall defective products, so as to avoid the phenomenon of 'bad money evicting good money'. The regulatory resources are focused on the highest risk, the most vulnerable part, implementing scientific supervision and efficient supervision.