The article discusses the U.S. Food and Drug Administration’s (FDA) concerns about the quality of Chinese-made plastic syringes and broader issues with Chinese-manufactured medical products. Suzanne Schwartz, a director at the FDA’s Center for Devices and Radiological Health (CDRH), highlighted that the problems with these products are systemic and have been ongoing for years, not just recently.
The FDA has issued warnings and recalls related to Chinese plastic syringes, but the concerns extend to other medical products from China. The shift in syringe manufacturing from the U.S. to China, driven by cost factors, has led to increased scrutiny and resource allocation by the FDA, revealing deficiencies in quality control by some Chinese manufacturers.
Schwartz emphasized the importance of adequately funding the FDA’s Office of Supply Chain Resilience (OSCR), which has been crucial in preventing product shortages. However, the office faces potential funding cuts as COVID-19 supplemental funds are set to expire, risking the FDA’s ability to maintain its current level of oversight.
The FDA relies heavily on reports from healthcare providers and consumers to identify issues with medical products and urges continued vigilance in reporting substandard products.