The Veterans Health Administration (VHA) banned the use of plastic syringes made in China on April 23 due to safety concerns, ahead of a warning letter dated April 24 to Ohio-based importer Cardinal Health by the Food and Drug Administration.
Previously, on April 10, 2024, the FDA announced expanded actions for Jiangsu Shenli Medical Production Co. Ltd. – a mainland manufacturer of plastic syringes – which resulted in animport alert for not meeting device quality system requirements. The import alert banned all Jiangsu Shenli’s plastic syringes from entering the United States.
The investigation into China-made syringes began in November but complaints about faulty syringes date back to 2020.
The FDA said in December that plastic syringes from China can cause “serious injury, including inaccurate dosing and adverse effects such as allergic reactions, irritation/inflammation, or organ failure.” The FDA received reports from medical centers of injuries caused by the imported syringes.
The VHA Procurement and Logistics Office said that the impacted syringes from China are no longer allowed for purchase through the vendors listed on the VA’s Medical Surgical Prime Vendor list. These prime vendors are where Veterans Hospitals go to procure generic drugs and medical devices, including imported goods from World Trade Organization members that are party to the Government Procurement Agreement (GPA) on government contracts. This would include Hong Kong, a party to that agreement.
The VHA said in its April 23 note that hospitals are encouraged to “maximize the use of alternative sources for plastic syringes” distributed by their prime vendors so long as it is not made in China, and is compliant with trade agreements like the GPA.
There are very few domestic manufacturers of these devices, an industry long overrun by imports.
U.S. dependence on imports for drugs and basic medical devices is dangerous, and the FDA knows it. CPA authors provided a solution to this dependency in an American Affairs journal article published in February.
Over the last two years, two of the three largest domestic manufacturers of syringes and needles closed their U.S. facilities and began sourcing products exclusively from Chinese manufacturers.
The United States uses roughly ten million units of syringes daily, according to industry data. Roughly two-thirds of all medical procedures in the United States require a syringe or a needle, be it for use in a sodium chloride drip, or to deliver general anesthesia for surgery.
According to a report from MERICS, China is the market-leading source of syringes and needles circulating in the U.S.
Import data shows that shipments of Chinese-made syringes increased 51% in 2023. After two U.S. manufacturers of syringes began outsourcing production, serious quality issues began.
In their November 2023 report on syringes imported from China, the FDA said it received information about “quality issues associated with several Chinese manufacturers of syringes.”
Cardinal Health followed VA prime vendor Medline Industries out of Illinois, which was first to get its warning letter on March 18.
According to the FDA’s online database, the last time the FDA even inspected a Chinese hypodermic device manufacturing facility was way back in 2018.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
Veterans Hospitals Ban Use of China-Made Syringes Due to Safety Issues
The Veterans Health Administration (VHA) banned the use of plastic syringes made in China on April 23 due to safety concerns, ahead of a warning letter dated April 24 to Ohio-based importer Cardinal Health by the Food and Drug Administration.
Previously, on April 10, 2024, the FDA announced expanded actions for Jiangsu Shenli Medical Production Co. Ltd. – a mainland manufacturer of plastic syringes – which resulted in an import alert for not meeting device quality system requirements. The import alert banned all Jiangsu Shenli’s plastic syringes from entering the United States.
The investigation into China-made syringes began in November but complaints about faulty syringes date back to 2020.
The FDA said in December that plastic syringes from China can cause “serious injury, including inaccurate dosing and adverse effects such as allergic reactions, irritation/inflammation, or organ failure.” The FDA received reports from medical centers of injuries caused by the imported syringes.
The VHA Procurement and Logistics Office said that the impacted syringes from China are no longer allowed for purchase through the vendors listed on the VA’s Medical Surgical Prime Vendor list. These prime vendors are where Veterans Hospitals go to procure generic drugs and medical devices, including imported goods from World Trade Organization members that are party to the Government Procurement Agreement (GPA) on government contracts. This would include Hong Kong, a party to that agreement.
The VHA said in its April 23 note that hospitals are encouraged to “maximize the use of alternative sources for plastic syringes” distributed by their prime vendors so long as it is not made in China, and is compliant with trade agreements like the GPA.
There are very few domestic manufacturers of these devices, an industry long overrun by imports.
U.S. dependence on imports for drugs and basic medical devices is dangerous, and the FDA knows it. CPA authors provided a solution to this dependency in an American Affairs journal article published in February.
Over the last two years, two of the three largest domestic manufacturers of syringes and needles closed their U.S. facilities and began sourcing products exclusively from Chinese manufacturers.
The United States uses roughly ten million units of syringes daily, according to industry data. Roughly two-thirds of all medical procedures in the United States require a syringe or a needle, be it for use in a sodium chloride drip, or to deliver general anesthesia for surgery.
According to a report from MERICS, China is the market-leading source of syringes and needles circulating in the U.S.
Import data shows that shipments of Chinese-made syringes increased 51% in 2023. After two U.S. manufacturers of syringes began outsourcing production, serious quality issues began.
In their November 2023 report on syringes imported from China, the FDA said it received information about “quality issues associated with several Chinese manufacturers of syringes.”
Cardinal Health followed VA prime vendor Medline Industries out of Illinois, which was first to get its warning letter on March 18.
According to the FDA’s online database, the last time the FDA even inspected a Chinese hypodermic device manufacturing facility was way back in 2018.
MADE IN AMERICA.
CPA is the leading national, bipartisan organization exclusively representing domestic producers and workers across many industries and sectors of the U.S. economy.
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