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Medical device fast-tracked for production
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A much needed medical device is being fast-tracked for industrial production.
Invented 10 years ago, the device — a kind of medical bag — has greatly improved the survival rate of babies born with holes in their bellies.
The device has now become the first of its kind to be accepted by authorities to go through the green channel process for industrial production approval thanks to a policy that took effect on September 1.
The policy was introduced in Shanghai to break through barriers for innovative products and to push faster approval for medical devices that can help to resolve urgent clinical needs. Officials said the bags’ production could be approved within a month.
The bag was invented by Dr. Wu Yeming from Xinhua Hospital for babies with gastroschisis, a birth defect whereby the baby’s intestines have extended outside the body through a hole next to the belly.
The occurrence rate of gastroschisis is low, but the death rate is high as infection is common.
The bag invented by Wu can be easily placed into babies’ bodies, helping them to avoid pain from drugs and stitches.
He also added a monitoring pipe to the bag so that medical staff can check bacteria conditions in the device.
Wu’s invention has won support from the government and received four patents, but he has still had difficulties bringing it into industrial production.
Wu pointed out that the occurrence rate of gastroschisis was so low that a renowned hospital like Xinhua received less than 10 a year. Most companies as result would not want to spend large sums on clinical tests for a product with such a potentially small market.
Because of the small numbers of cases, it also difficult to collect enough examples for clinical tests to apply for production approval from the Food and Drug Administration.
In 2007, a local company produced 300 samples for Wu after the firm’s boss was touched by Wu’s efforts to bring the bag into industrial production.
“Though it could not be produced in bulk yet, many of my patients were saved,” Wu said.
The bags were used for a clinic research program in Xinhua and they increased survival rate of babies with gastroschisis in the hospital up to 94.1 percent.
But as the bag has no registered certificates as a medical device, it cannot be expanded into other medical institutions. The new policy has brought new hope that this will soon change.
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