Tuesday, April 16, 2024

FDA Issues Class I Notice for Becton Dickinson Infusion Pumps Over Compatibility Concerns

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In a recent development, the Food and Drug Administration (FDA) has taken a significant step by issuing a Class I notice regarding Becton Dickinson (BD) infusion pumps. This notice primarily addresses compatibility concerns with Cardinal Health Monoject syringes. This announcement comes after Cardinal Health issued an urgent medical device product correction in September to alert healthcare providers about compatibility issues between specific lots of Monoject syringes and certain infusion pumps, with a particular focus on BD’s Alaris pumps.

The FDA’s classification of this notice as Class I signifies the seriousness of the issue and emphasizes the need for prompt action. Class I recalls are reserved for situations where there is a reasonable probability that using the product in question may result in severe health consequences or even death. Therefore, the FDA’s alert serves as a crucial warning to healthcare providers and patients using these medical devices.

Rebranding of Monoject Syringes by Cardinal Health Sparks Compatibility Crisis with BD’s Infusion Pumps

The core problem revolves around the compatibility between Monoject syringes, which were rebranded by Cardinal Health, and BD’s Alaris pumps. These syringes, previously sold under the Covidien brand, underwent significant changes when Cardinal Health rebranded them in June. This rebranding not only changed the appearance but also altered the dimensions of the syringes, making them incompatible with specific infusion pumps, particularly BD’s Alaris pumps.

The consequences of this compatibility issue prompted BD to take swift action. In September, BD issued an urgent medical device labeling correction to notify its customers about the incompatibility between certain Monoject syringes, now under Cardinal Health branding, and its Alaris Syringe and PCA Modules. BD urged healthcare providers to discontinue the use of these affected syringes with their BD devices and recommended updating their lists of compatible devices accordingly.

The scale of the problem becomes apparent when considering the number of affected devices. The BD correction impacts a significant quantity of syringe pumps and patient-controlled analgesia (PCA) modules, totaling 220,120 units, in addition to 867,362 pump control unit modules distributed across the United States. This widespread distribution indicates that a substantial portion of the healthcare system may have encountered these compatibility issues.

Infusion Pumps

Compatibility Concerns between BD Infusion Pumps and Monoject Syringes

Despite the severity of the issue, no fatalities have been reported in connection with these compatibility problems, with 13 documented injuries highlighting the need for prompt action. The widespread use of Monoject syringes with infusion pumps compounds the problem, particularly as the Alaris 8015 user manual mentions Monoject as an example, exacerbating compatibility issues.

The FDA’s involvement goes beyond the Class I notice, with the agency expressing concerns in a letter to providers about Cardinal Health’s handling of the issue, emphasizing its commitment to patient safety. Additionally, the FDA issued an advisory against Chinese-made plastic syringes due to quality concerns, though this doesn’t apply to BD’s syringes, which are mostly manufactured in the United States.

In conclusion, the FDA’s Class I notice regarding BD infusion pumps and their compatibility issues with Cardinal Health Monoject syringes highlights the need for swift action and vigilance in the healthcare industry. The rapid responses from BD and the FDA demonstrate their dedication to patient safety and the integrity of medical devices used in healthcare settings. Addressing this issue is crucial to prevent further harm and ensure the continued safe use of these essential medical devices.

 

Resource: Medtechdive, December 04, 2023

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