On January 11, 2017, the FDA announced it received reports of serious adverse events, including patient injury and death, associated with the use of implantable infusion pumps in the magnetic resonance (MR) environment. These reports describe medication dosing inaccuracies (e.g., over-infusion or under-infusion, unintended bolus) and other mechanical problems with the pump (e.g., motor stall, pump not restarting after a Magnetic Resonance Imaging (MRI) exam).
Implantable infusion pumps are devices that are surgically implanted under the skin, typically in the abdominal region. They are connected to an implanted catheter and are used to deliver medications and fluids within the body. Implantable infusion pumps are periodically refilled with medications or fluids by a health care provider. Implantable infusion pumps may be used to treat chronic pain, muscle spasticity, and many other diseases or conditions.
MRIs are medical diagnostic exams that create images of internal structures of the body by using strong magnetic fields and radio waves (radiofrequency energy). These images provide information to physicians and can be useful in diagnosing a wide variety of diseases and conditions.
The MR environment presents safety hazards for patients with implantable infusion pumps. Only implantable infusion pumps labeled as “MR Conditional” may be used safely within an MR environment, and only under the specified conditions of safe use. The specific conditions that health care practitioners and patients should follow before, during, and after the MRI exam vary by the make and model of the implantable infusion pump system. Importantly, each implantable pump model may have unique conditions that must be followed in order for a patient to safely undergo an MRI exam. Failure to adhere to these conditions can result in serious injury or death.
An analysis of adverse event information and manufacturer labeling alerted the FDA to a potential safety problem with the use of implantable infusion pumps in the MR environment. The FDA is working with the applicable manufacturers to update MRI safety information in their labeling to ensure that instructions for the safe use of these devices are clear and up-to-date with current terminology and definitions.
See the FDA Safety Alert
See also Medical Law Perspectives, June 2014 Report: Physician and Manufacturer Risks for Pain Pump Injuries: Malpractice, Negligence, and Products Liability
See the Medical Law Perspectives February 10, 2015, Blog: Infusion Pump Failures: Product Liability and Human Error