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Implantable Infusion Pumps Raise Safety Concerns

Jan 13, 2017

Implantable infusion pumps are medical devices that are surgically implanted below the skin, normally in the abdominal area. They are designed to deliver medications and fluids within the body. Infusion pumps are connected to an implanted catheter and may be used to treat cancer, chronic pain, muscle spasticity, and a variety of other conditions or diseases.

What is an MRI?

Implantable Infusion Pumps Raise New Safety Concerns

MRI (magnetic resonance imaging) is a medical diagnostic examination that makes images of the internal structures of the body by using strong magnetic fields and radio waves (radiofrequency energy). These images give information to doctors and may be useful in diagnosing a wide array of diseases and conditions. In some cases, medical devices, including some implantable infusion pumps, may be affected by the strong magnetic fields linked to the MRI.

Safety Issues Concerning Infusion Pumps

Imp lantable drug pumps are prescribed for patients with serious conditions, who do not respond to oral medications or who experience severe side effects when taking such medications.

The U.S. Food and Drug Administration (FDA) is informing patients, caregivers, technologists, and health care providers of important safety precaution to ensure patients with implantable infusion pumps may safely have an MRI exam.

The agency has received reports of serious adverse events that include patient injury and death linked to the use of implantable infusion pumps in the MR (magnetic resonance) environment. These reports tell of medication dosing inaccuracies such as over-infusion, under-infusion, and unintended bolus (rounded lump or mass). In addition, mechanical problems with the pump were reported such as the motor stalling, or the pump not restarting after the MRI examination, the FDA reports.

Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have suffered injury from medical devices including implantable infusion pumps.

The MRI system can be useful in diagnosing a wide variety of conditions and diseases. However, the MR environment creates safety hazards for patients with implantable infusion pump. Implantable infusion pumps labeled as MR Conditional only, may be used safely within an MR environment, and solely under the specified conditions of safe use, according to the FDA website.

The specific conditions that health care practitioners and patients should follow throughout the MRI exam may vary according to the make and model of the implantable infusion pump. Importantly, in order for a patient to safely undergo an MRI exam, each implantable pump model may have unique conditions that must be followed exactly. Neglecting to adhere to these conditions may result in serious injury or even death, according to the FDA.

The benefits and risks of an MRI exam must be weighed for each individual patient. The value of the information gained from the MRI exam should be carefully considered against the risks. All medical devices in the MR environment during the exam, including implants, external devices, and accessory devices, should be reviewed.

Prevention of Adverse Events

Prevention of Adverse Events

Individuals who are scheduled for an MRI should be sure to alert their physician and MRI technician if they have an implantable infusion pump. Most patients are provided with an “implant card” listing specific identification information about their pump that should be shared with the appropriate people.

If there is a question concerning the make and model of the implantable pump, it is vital to contact the physician who manages the pump for those specifics, before an MRI exam proceeds. A medical alert bracelet or necklace including information that the person has an implantable pump may be considered to ensure that in case of an emergency situation, that information is immediately available.

An MRI exam may affect the programming or function of an infusion pump, even when specified conditions have been followed. It may be beneficial to have the implantable pump checked and/or reprogrammed by a physician before and after the MRI exam.

On occasion, some pumps may automatically stop delivering medication during an MRI exam. Depending on the medication that is being delivered by the implantable pump, alternative drug therapy may be required to be used to prevent drug withdrawal. Also, some pumps may be required to be totally emptied of the drug prior to the MRI exam to prevent unintended over-delivery of medication and a potential drug overdose.

Legal Help for Implantable Pump Recipients

Parker Waichman LLP has had years of experience representing clients in numerous medical device lawsuits. The firm offers free, no-obligation legal case evaluations to anyone with questions about filing a lawsuit over implantable pump medical devices. We urge you to contact us at 1-800-YOURLAWYER (1-800-1968-7529).

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