Shanghai medical device recall, the number of domestically produced is increasing

Medical Network July 24th In the past few years, most of the medical device recall information released has been foreign-funded enterprises. But since last year, recall information involving local medical device companies has begun to appear, and There is an increasing trend.

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 are the main contents of the report:

Shanghai food in the first half of 2018 drug The Authority issued a total of 165 items medical instruments enterprise Proactive recall information. According to the product category, there are 100 active products, 37 passive products, and 28 in vitro diagnostic reagent products. According to the severity of product defects, 3 recalls, 52 recalls, and 3 Recalled 110 items.

The number of voluntary recalls released in the first half of the year increased by 66.7% compared with last year. From the analysis of the recalled enterprises, 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 supervisory and flight inspections initiated active recalls, medical device supervision sampling, flight inspections and 2. 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 active 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 failed to 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.

First, pay attention to the risk of blood glucose test strip defects. The first half of the first half of the blood glucose test paper recall is the glucose test strip (enzymatic method), the enzyme content is low, affecting the measurement results, and thus affecting the patient's medication, especially Pregnant woman The effect of medication errors on the fetus.

The second is to pay attention to the bacterial endotoxin risk of sterile products. In the first-level recall of the first half of the year, there were detectable levels of bacterial endotoxin on the product packaging hoop, which may cause cross-infection in clinical use.

The third is to pay attention to the risk of active implants due to power failure. heart In the recall of a cardioverter defibrillator product, the company uses 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, the number of labeling errors has increased, up 93% year-on-year, mainly due to incorrect registration number information. Happening.

At present, relevant medical device companies have investigated and evaluated possible defective products and adopted corresponding corrective and preventive measures.