FDA’s Alarming News on Faulty Chinese Syringes Calls for Strengthening America’s Medical Supply Chain
March 20, 2024

AMMA renews calls for increased purchasing and reliance on medical supplies and PPE made in America.

This week, the FDA released alarming revelations surrounding safety issues with medical syringes manufactured in China. The report illuminates a troubling reality: the integrity and reliability of our global medical supply chain are under threat. As reports of device failures and regulatory violations surface, it becomes increasingly clear that immediate action is needed to safeguard patient safety and protect public health primarily through investment and purchasing domestically manufactured critical public health supplies.

Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health (CDRH), announced on March 19, 2024, that the FDA identified and is taking action on ongoing quality and performance issues related to plastic syringes made in China. The FDA noted they are “actively evaluating quality issues and performance testing failures with plastic syringes” produced by Jiangsu Shenli Medical Production Co. Ltd., Medline Industries, LP, and Sol-Millennium Medical, Inc. The news broke as part of a months-long investigation by CNBC.

This announcement follows a 2023 FDA safety communication on the agency’s evaluation of potential device failures with certain plastic syringes made in China. The FDA received information about concerns with the performance and safety of certain syringes, including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps.

The FDA’s announcement underscores the urgent need for greater enforcement of quality assurance measures and a robust domestic manufacturing base for these items. The failures described in the FDA report pose grave risks to patient well-being and public health. These revelations are another wake-up call, highlighting the inherent vulnerabilities of relying on foreign suppliers for critical medical supplies.

American Medical Manufacturers Association (AMMA) Executive Director Eric Axel said, “Failures by foreign manufacturers pose a serious risk to our front-line workers and patients of all types. That’s why supporting domestic manufacturers is critical to preserving public safety. Domestic manufacturers adhere to the highest safety standards, whether their end products, in the workplace, or the environment.”

Domestic manufacturers have many oversight mechanisms. By supporting domestic manufacturing and encouraging all providers of PPE and medical supplies to do the same, the United States can work towards a safer and more reliable medical supply chain.

As a next step, Congress and the President must prioritize investments in domestic manufacturing capabilities for medical supplies and PPE. The COVID-19 pandemic laid bare the vulnerabilities of relying on overseas suppliers for essential medical products, prompting a reevaluation of the nation’s manufacturing strategy. These leaders should incentivize businesses to invest in advanced manufacturing technologies and infrastructure within the United States. Lawmakers can enhance supply chain resilience and reduce dependency on imports.

In addition, government incentives, such as tax breaks, access to working capital, direct investment, and market signaling to the private sector, can encourage companies to establish or expand manufacturing facilities for medical products and PPE domestically. These investments stimulate economic growth and job creation and bolster national security by ensuring a stable and secure supply of vital medical supplies. Moreover, localized production enables rapid emergency response, ensuring timely access to critical supplies for healthcare providers and first responders.

“The FDA reports are truly alarming. Congress should use all the tools available to spur domestic markets, strictly oversee inferior foreign products, and ensure our government leads by example in buying American. Furthermore, the Administration can partner with Congress in these efforts and must lead when it comes to American competitiveness,” said AMMA’s Eric Axel.

Buying domestic medical supplies and PPE is a matter of economic revitalization and a strategic imperative for national security and public health resilience. By incentivizing businesses to establish or expand manufacturing facilities within the United States, the government can mitigate reliance on dangerous and unchecked overseas suppliers and ensure a stable and secure supply of vital medical products.

Axel added, “The time is now to prioritize patient safety and public health by investing in a more resilient and reliable medical supply chain based in the USA.”