Saturday, June 22, 2024

Plastic Syringes Failure: FDA Expands ‘Do Not Use’ List to Include Two New Chinese Plastic Syringe Manufacturers

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Plastic syringes manufactured in China should be avoided, according to updated FDA recommendations for healthcare providers, due to numerous reports of leaks, breakage, and issues related to changes in syringe dimensions. This expanded recommendation includes an import alert for two additional Chinese manufacturers: Zhejiang Longde Pharmaceutical Co. Ltd. and Shanghai Kindly Enterprise Development Group Co. Ltd. This import alert aims to prevent plastic syringes produced by these companies from entering the United States, as they do not meet the FDA’s device quality system requirements.

In late 2023, the FDA initially issued a safety communication alerting consumers and healthcare providers about potential device failures with plastic syringes manufactured in China. At that time, the FDA did not specify any companies but noted it had received reports of quality issues, including leaks and breakages, from several Chinese manufacturers. Consequently, the agency recommended avoiding plastic syringes from China if possible to mitigate any risks associated with their use.

Following this initial notice, the healthcare industry speculated about which companies might be involved. Cardinal Health and Fresenius Medical Care were among those considered likely, especially since the FDA had issued a Class I recall to both companies just two weeks prior. The recall cited similar quality issues, such as leaks and changes to syringe dimensions, as those mentioned in the FDA’s safety communication. However, the FDA did not officially name Cardinal Health or Fresenius Medical Care in connection with the communication, leaving room for industry speculation and concern.

In the months following the initial notice, the FDA continued its investigation into the quality of plastic syringes. The agency conducted facility inspections at Medline Industries and Sol-Millennium Medical, detained and examined products at the border, and performed laboratory tests on the syringes. These comprehensive efforts were aimed at ensuring the safety and efficacy of plastic syringes used in medical settings across the United States.

FDA Issues Warnings to Companies Over Unauthorized Plastic Syringes from China

In March, the FDA issued warning letters to three companies: Jiangsu Shenli Medical Production (a China-based manufacturer of plastic syringes), Medline Industries, and Sol-Millennium Medical. These letters described violations related to the sale and distribution of unauthorized plastic syringes manufactured in China that had not been cleared or approved by the FDA for use in the United States. Additionally, the FDA’s warning letter to Medline indicated that the agency was evaluating quality and performance issues related to plastic syringes made by another China-based company, Jiangsu Caina Medical, citing “unexpected and unexplained failures” in several of their products.

The warning letters underscored the serious nature of these quality issues, highlighting the potential risks posed by defective plastic syringes. The FDA’s actions were a clear indication of its commitment to ensuring that only high-quality, reliable medical devices are used in the United States, thereby protecting both healthcare providers and patients from potential harm.

In its May update, the FDA added Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group to its list of manufacturers whose plastic syringes are recommended for avoidance. The list now includes four specific manufacturers: Jiangsu Caina Medical, Jiangsu Shenli Medical Production, Zhejiang Longde Pharmaceutical, and Shanghai Kindly Enterprise Development Group. This expanded list reflects the FDA’s ongoing efforts to identify and address any potential sources of risk in the medical device supply chain.

Plastic Syringes

FDA Advises Caution with Chinese-Manufactured Plastic Syringes Amid Quality Concerns

The FDA continues to advise healthcare facilities to use plastic syringes not manufactured in China whenever possible. However, if a facility has only Chinese-manufactured syringes available, the agency recommends continuing to use them as needed while closely monitoring for leaks, breakage, and other problems. This cautious approach aims to balance the immediate need for medical supplies with the long-term goal of ensuring device safety and reliability.

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This expanded import alert and updated recommendation highlight the FDA’s ongoing commitment to ensuring the safety and efficacy of medical devices used in the United States. By identifying and addressing quality issues with plastic syringes, the FDA aims to protect healthcare providers and patients from potential harm caused by defective products. This proactive approach underscores the importance of rigorous quality control and compliance with FDA regulations in the manufacturing of medical devices, particularly those critical to patient care.

In late 2023, the FDA initially issued a safety communication alerting consumers and healthcare providers about potential device failures with plastic syringes manufactured in China. At that time, the FDA did not specify any companies but noted it had received reports of quality issues, including leaks and breakages, from several Chinese manufacturers. Consequently, the agency recommended avoiding plastic syringes from China if possible.

Following this initial notice, the healthcare industry speculated about which companies might be involved. Cardinal Health and Fresenius Medical Care were among those considered likely, especially since the FDA had issued a Class I recall to both companies just two weeks prior. The recall cited similar quality issues, such as leaks and changes to syringe dimensions, as those mentioned in the FDA’s safety communication.

FDA Expands List of Chinese Plastic Syringe Manufacturers to Avoid, Emphasizes Rigorous Quality Control

Tthe FDA did not officially name Cardinal Health or Fresenius Medical Care in connection with the communication. In the months following the initial notice, the FDA continued its investigation into the quality of plastic syringes. The agency conducted facility inspections at Medline Industries and Sol-Millennium Medical, detained and examined products at the border, and performed laboratory tests on the syringes.

In its May update, the FDA added Zhejiang Longde Pharmaceutical and Shanghai Kindly Enterprise Development Group to its list of manufacturers whose plastic syringes are recommended for avoidance. The list now includes four specific manufacturers: Jiangsu Caina Medical, Jiangsu Shenli Medical Production, Zhejiang Longde Pharmaceutical, and Shanghai Kindly Enterprise Development Group. The FDA continues to advise healthcare facilities to use plastic syringes not manufactured in China whenever possible. However, if a facility has only Chinese-manufactured syringes available, the agency recommends continuing to use them as needed while closely monitoring for leaks, breakage, and other problems.

This expanded import alert and updated recommendation highlight the FDA’s ongoing commitment to ensuring the safety and efficacy of medical devices used in the United States. By identifying and addressing quality issues with plastic syringes, the FDA aims to protect healthcare providers and patients from potential harm caused by defective products. This proactive approach underscores the importance of rigorous quality control and compliance with FDA regulations in the manufacturing of medical devices, particularly those critical to patient care.

As healthcare providers navigate these updated recommendations, they are encouraged to stay informed about further developments and guidance from the FDA. The agency’s efforts to monitor and regulate the quality of medical devices will continue to play a crucial role in maintaining the integrity of the healthcare system and ensuring the safety of patients and providers alike.

 

Resource: Food and Drug Administration, May 16, 2024

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