December 1, 2023: The US Food and Drug Administration (USFDA) is assessing the potential for failures in plastic syringes manufactured in China.
“The FDA is collecting and analyzing data to evaluate plastic syringes made in China used for injecting fluids into or withdrawing fluids from, the body,” according to a statement.
The probe into leaks, breakages and other problems does not include glass syringes, pre-filled syringes, or syringes used for oral or topical purposes.
“We are concerned that certain syringes manufactured in China may not provide consistent and adequate quality or performance.”
The drug regulator urged consumers and healthcare providers to consider using syringes not manufactured in China, if possible.
Inability to deliver correct dosage
A is used in a variety of clinical and home health settings. Some syringes may also be used with infusion pumps to deliver fluids into the body in a controlled manner.
The FDA is aware of quality issues from recent syringe recalls, Medical Device Reports (MDRs), and additional complaints about syringes made at various manufacturing sites in China.
“These quality issues may affect the performance and safety of the syringes including their ability to deliver the correct dose of medication when used alone or with other medical devices such as infusion pumps,” according to the USFDA statement.
The FDA plans to work with manufacturers to ensure adequate corrective actions are taken, and, as necessary, may prevent syringes made in China from entering the US. It will continue monitoring reports of problems with syringes manufactured in China.
The US disposable syringes market size was valued at $2,435.64 million in 2022 and is expected to expand at a compound annual growth rate of 5.43% from 2023 to 2030 to reach $3,694.39 million by 2030, according to Grand View Research.
The growth is attributed to the growing prevalence of chronic disorders, increasing adoption of safety syringes, and a rising number of surgeries in the US.
According to the American Heart Association, 45.1% of the U.S. population, or more than 130 million adults, are projected to suffer from some form of cardiovascular disease by 2035.
About 655,000 Americans die from heart disease annually, that’s 1 in every 4 deaths.