The US Food and Drug Administration (FDA) recently announce a recall of a medical device widely used during life-saving procedures.
Medical technology company Becton, Dickinson and Company (BD) is a global enterprise selling instruments, medical devices and treatment systems. The FDA recently issued a Class 1 recall on BD Intraosseous Needle Set Kits, Manual Driver Kits, and Intraosseous Powered Drivers.
An intraosseous (IO) device is a tool that drives a hollow needle through bone to the marrow to collect lab samples or to infuse therapeutic drugs. Because bone marrow is dense with vascular tissue, it is an ideal space to deliver drugs needed during critical procedures like resuscitation. IO therapy was first used in the 1940s and is used in instances when time is of the essence and intravenous drug delivery is not fast enough. For a skilled practitioner, an IO line can be placed within about one minute making it a route of choice when a patient is in cardiac arrest, shock, suffering serious dehydration, or a hemorrhage.
A Class 1 recall is the most serious form of recall warning produced by the FDA. A Class 1 recall is intended to warn of a situation, device, or product that carries a “reasonable probability” that use of the product will cause an adverse medical event or death. Along with the Class 1 recall by the FDA, manufacturer BD has voluntarily recalled the needle kits and products related to the recall.
The FDA identified several issues with the Becton Dickinson IO kits, including:
- The needle parts may be difficult to separate, rendering the device inoperative or difficult to use.
- A safety mechanism on the needle may not deploy as needed after placement.
- Metal pieces may adhere in the driver—potentially leaving the driver inoperable.
BD notes the problems with the needle kits could cause delays in treatment of critically ill or injured patients. Delay in treatment or resuscitation could lead to further injury or death. Additionally, healthcare providers are at risk of harm from needlesticks. The FDA has received 37 complaints regarding the devices—none of which have resulted in serious injury or death.
The manufacturer advises healthcare providers to identify and cease using the devices. At present there is no replacement product from BD and providers are advised to use other IO devices.
In this instance, and with other device failures, poor product design or maintenance can cause serious injury or death.
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