Taiwan is to see a shortage of large intravenous fluid (IV) bags until October, the Food and Drug Administration (FDA) said on Wednesday, after the nation’s top provider of the medical product was ordered to stop production.
YF Chemical Corp (永豐化學), which provides 70 percent of the nation’s saline IV bags, was ordered to cease production after “serious contraventions” of internationally recognized standards of good manufacturing practice.
After the notice was released last week, the Federation of Taiwan Pharmacists Associations expressed concern that the shortage could imperil hospital operations.
Photo: Chang Chia-ming, Taipei Times
The FDA on Monday said that other manufacturers capable of supplying 14 of YF Chemical’s sodium chloride products have already been asked to increase production.
Three companies have expressed willingness to import another seven products from Japan and other countries, it said.
As for the remaining three products, the FDA estimated that it has enough supply to last at least three months.
The items most at risk of a shortage are saline for irrigation and injectable saline, it added.
On Wednesday, FDA Deputy Director-General Wang Der-yuan (王德原) told reporters over the telephone that supply for irrigation saline should stabilize by next month as other manufacturers increase production.
However, supply of large bags of sodium chloride for IV injection would likely take longer to stabilize, Wang said.
Converted to 500ml units, YF Chemical typically provides 1.96 million bags per month, he said.
Initial estimates indicate a shortage of 1.1 million bags next month, and another 1.5 million needed monthly from July, he said, adding that existing stock of YF Chemical IV bags is to start running out from around the middle of next month.
However, supply should be sufficient through next month as other manufacturers increase production and companies have expressed willingness to import, Wang said.
The Ministry of Labor has agreed to ease overtime restrictions for manufacturers from July, but special imports would still be needed until YF Chemical improves its production processes, he said.
Shortages of large IV bags are projected to continue until October, Wang said, but added that it could return to normal earlier if other manufacturers can ramp capacity or YF Chemical restarts production.
Wang also vowed that the FDA would focus on market diversification of such products to prevent a similar shortage from occurring in the future.
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