Watchdog finds defective condoms, catheters, IV sets

The China Food and Drug Administration said on Tuesday that it will levy harsher punishments for the illegal production and sale of medical equipment after it discovered defective products in a nationwide survey.

On March 15, the CFDA launched an ongoing program to overhaul the medical equipment industry. As part of the overhaul, food and drug administrations in 31 provincial regions tested 1,417 batches of medical equipment, including 66 batches of natural latex rubber condoms.

The condoms came from manufacturers and distributors in Beijing and from the provinces of Liaoning, Henan, Shandong, Hubei, Guangdong and Fujian.

Three batches from Shandong and Fujian failed to meet national standards because samples failed to take on as much air pressure as required. One of the three batches had condoms dotted with pinholes.

The food and drug administration in Changsha, Hunan province, and the local police raided a company that had been making counterfeit condoms, said Mao Zhenbin, director of the CFDA inspection bureau.

"The company purchased unpackaged condoms at a low price. They then packaged them as products under well-known brands and sold them at high prices. Some of the condoms they bought were past expiration," he said.

Law enforcement seized roughly 6 million condoms and 28.7 million partially manufactured condoms from the company, with value totalling more than 200 million yuan ($32.24 million).

A condom is classified as Class 2 medical equipment, and strict requirements apply to its production. But it's also an easy target for illegal production because it is widely used in large amounts, Mao said.

The CFDA said it also has found defective products after sampling 33 batches of dialysis concentrates made or sold in Beijing, Tianjin, Shanghai and Hebei.

"Dialysis concentrates that are substandard in terms of the maximum level of microorganisms allowed can cause acute or chronic complications," said Tong Min, head of the medical equipment supervision and management department at the administration.

Other products found to be defective were disposable and sterile syringes, disposable packages of sterile urethral catheterization equipment and disposable intravenous infusion sets, according to the administration.

"In the next stage of the overhaul program, we will put more effort into punishing illegal cases, impose heavier punishments and close cases more quickly," Tong said.

wangqingyun@chinadaily.com.cn

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