Shanghai Food and Drug Administration released medical device recall report
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On July 20, the Shanghai Food and Drug Administration issued a report on the recall of medical device companies in the city, which confirmed this point: the number of domestic recalls is increasing. The following is the main content of the report:
In the first half of 2018, the Shanghai Food and Drug Administration issued a total of 165 medical device companies to actively recall information. According to the product category, 100 active products, 37 passive products, and 28 in vitro diagnostic reagent products; according to the severity of product defects, 3 first-level recalls, 52 second-level recalls, and 110 third-level recalls.
The number of voluntary recalls released in the first half of the year increased by 66.7% year-on-year. From the analysis of the recalled enterprise main body, the number of voluntary recalls of domestic medical devices increased. In the first half of the year, 11 domestic medical devices were actively recalled.
Among them, 2 recall actions were initiated due to unsatisfactory random inspection, 2 recall actions were initiated due to defects found in flight inspections, and product defects found in supervision sampling and flight inspections initiated active recalls, medical device supervision sampling inspections, flight inspections and The active recall has formed an effective linkage and initially formed a regulatory force.
In the first half of 2018, the main reasons for the voluntary recall were product design defects, production process control defects, and labeling errors.
The recall incidents caused by product design defects accounted for about 48% of the total, including product failures caused by product software defects; the recall events caused by production process control defects accounted for about 30% of the total, due to assembly errors, packaging failures, etc. The final product did not fully realize the intended use of the product.
Another recall caused by the labeling error accounted for 18% of the total, mainly due to incorrect information such as the registration number on the Chinese label; recalls and other categories of recalls accounted for 4% of the total.
One is to pay attention to the risk of blood glucose test strip defects. The first-half recall of blood glucose test strips in the first half of the year was due to the low enzyme content of the glucose test strip (enzymatic method), which affected the results of the assay, which in turn affected the patient's medication, especially the effect of misuse of pregnant women on the fetus.
The second is to focus on the bacterial endotoxin risk of sterile products. In a first-level recall in the first half of the year, there was a detectable level of bacterial endotoxin on the product packaging hoop, which may cause cross-infection in clinical use.
The third is to focus on the risk of active implants due to power failures. In a recall of a cardioverter defibrillator product, the company used an firmware upgrade based on the product's own battery performance test to alert the battery performance anomaly.
The fourth is to pay attention to the risk of compliance caused by incorrect label identification. In the first half of the 2018 medical device voluntary recall event, the number of labeling errors increased, up 93% year-on-year, mainly due to incorrect registration number information.
At present, relevant medical device companies have conducted investigation and evaluation of possible defective products and adopted corresponding corrective and preventive measures.
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