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The “lifesaving bag” that was inventedby pediatricians a decade ago can finally be used in clinic, thanking to the preferential approval procedures for medical devices in Shanghai. On November 1, the Shanghai Food and Drug Administration announced that“gastroschisis protection bag” invented by Professor Wu Yeming, from the Pediatric Surgery Department of Xinhua Hospital affiliated toShanghai JiaoTong University School of Medicine,has gottenpriority approvalto“green channel”into Shanghai “the second type of medical device priority approval process”, which was expected to be put into production during the year.
Gastroschisis is one of the congenital malformations with high risk in newborn infants, in which a large number of intestines will run out of the stomach that becomes extremely prone to infection. Although the incidence rate is not high, in our country, the perinatal mortality rate is as high as 74.69%, while in the United States is only 8.7%. In the 1990s, when studying in the United States, Wu Yeming found that Americans used a special protective bag to temporarily protect the exposed intestine in the bag. As the natural growth and development, the exposed gut would get gradually retracted into the abdomen. In China, most doctors use other kinds of medical bags to cover the exposed parts and suture the bags to theabdomen under anesthesia, in which case the children get great trauma.
After returning home, Wu Yeming began to design suitable special protective bags: the bag mouth could be freely squeezed, could easily enter the children‘s abdomen and not easy to fall off, eliminating the need for stitching and anesthesia; at the same time, by increasing the monitoring pipeline, health care workers can monitor the bacteria in the bag which improves the safety of intestinal protection. Due to the convenient operation, some operation can be done by the nurse at the bed of the newborn care unit.
This design gets supported by scientific research projects such as Shanghai Science and Technology Commission, Shanghai Health and Family Planning Commission and Shenkang Hospital Development Center, and also obtained the invention patent. However, the incidence of abdominal cracking is not high, the investment is disproportionateto outputso that many manufacturers remain prohibitive. At that time, only one company produced 300 clinical trial samples for Wu Yeming for scientific research. During the implementation of the project, the survival rate of patients with pediatric gastroschisis increased to 94.1%. Pediatric surgeons all over the country wanted to obtain this “ protection bag. ” However, because there is no product registration card, it cannot be formally promoted and used clinically in medical institutions.
Until now, Shanghai implemented “the second type of medical device priority approval process.” “Priority examination and approval procedure” refers to thataccording to the request of the applicant,medical equipment products that are included in the priority examinationcould get approval of such special priority approval procedure as related examination, review, approval before the application for registration, examination and approval. The program, developed by the Shanghai Food and Drug Administration, has come into effect sinceSeptember 1 this year,which is valid for 5 years. According to the procedure, those clinically urgently needed and those listed in the national science and technology major projects of Shanghai Municipality or key R & D programs will be sorted and prioritized in the approval process to ensure that they can be listed as fast as possible to help patients.
The “life-saving bag” became the first product to enter the “green passage” for priority approval. Wu Ye-ming said that thanks to the gateway for the rapid declaration of rare diseases, and the Shanghai Food and Drug Administration had accelerated the real landing of this policy, making it possible for “gastroschisis protection bags” to be transformed into clinical applications.