Minister of Health and Welfare Chen Shih-chung (陳時中) on Wednesday said he hopes the Legislative Yuan would pass a draft amendment to the Regulations for Governing the Management of Medical Devices (醫療器材管理法) that would improve the traceability of medical devices after authorities were unable to determine the use of devices from a recent recall.
The Food and Drug Administration (FDA) last week said it discovered in August that Ai-Shi-Po (艾斯博有限公司) had allegedly commissioned two manufacturers to make and supply medical bone plates and screws to hospitals without obtaining the Good Manufacturing Practice (GMP) certification in advance.
Ai-Shi-Po allegedly sold more than 70,000 of these parts to 81 healthcare facilities, including major medical centers, between January and July, before it earned GMP certification on July 11, the FDA said.
The FDA ordered the company to recall all the bone plates and screws last month, and as of last Wednesday, a total of 75,299 parts had been returned, the FDA said.
However, the batch numbers and detailed information on where the bone plates and screws were used are still unknown.
An FDA official said Ai-Shi-Po might have used legal batch numbers on the illegal products, so it would be meaningless to publicly announce these numbers.
FDA Director-General Wu Shou-mei (吳秀梅) said on Wednesday that the case is now being investigated by the Kaohsiung District Prosecutors Office.
Chen said the ministry had proposed an amendment to the Regulations for Governing the Management of Medical Devices to improve the traceability of medical device usage in late 2017, but it has not been passed by the Legislative Yuan because there are different opinions on who could sell the medical devices. He hopes the Legislative Yuan would pass this legislation soon.
Additional reporting by CNA
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