Initial testing of pegfilgrastim (Neulasta Onpro) on‐body injector in multiple radiological imaging environments

Abstract

PurposeAn increasing number of implantable or external devices can impact whether patients can receive radiological imaging examinations. This study examines and tests the Neulasta (pegfilgrastim) Onpro on‐body injector in multiple imaging environments.MethodsThe injector was analyzed for four imaging modalities with testing protocols and strategies developed for each modality. In x‐ray and computed tomography (CT), scans with much higher exposure than clinical protocols were performed with the device attached to an anthropomorphic phantom. The device was monitored until the completion of drug delivery. For magnetic resonance imaging (MRI), the device was assessed using a hand‐held magnet and underwent the magnetically induced displacement testing in a 1.5T clinical MRI scanner room. For ultrasound, magnetic field changes were measured around an ultrasound scanner system with three transducers.ResultsFor x‐ray and CT no sign of device error was identified during or after the high radiation exposure scans. Drug delivery was completed at expected timing with expected volume. For MRI the device showed significant attractive force towards the hand‐held magnet and a 50‐degree deflection angle at 50 cm from the opening of the scanner bore. No further assessment from the gradient or radiofrequency field was deemed necessary. For ultrasound the maximum magnetic field change from baseline was measured to be +11.7 μT in comparison to +74.2 μT at 4 inches from a working microwave.ConclusionsNo device performance issue was identified under the extreme test conditions in x‐ray or CT. The device was found to be MR Unsafe. Magnetic field changes around an ultrasound system met the limitation set by manufacture. Patient ultrasound scanning is considered safe as long as the transducers do not inadvertently loosen the device.

Safety Considerations in MRI and CT

“…Partial electrical reset safety features were activated in two models at maximum doses but not at typical dose levels, and no devices were permanently damaged. A subsequent study on the impact of CT scans on a pegfilgrastim on-body injector at a much higher radiation dose than in routine scans found no sign of device error during or after the scans 68 . Based on available evidence over many years, the FDA determined that, even with the small number of reports of adverse effects received, little evidence existed that CT exposure was the cause of those events.…”

“…A subsequent study on the impact of CT scans on a pegfilgrastim on-body injector at a much higher radiation dose than in routine scans found no sign of device error during or after the scans. 68 Based on available evidence over many years, the FDA determined that, even with the small number of reports of adverse effects received, little evidence existed that CT exposure was the cause of those events. The FDA concluded that the probability of an adverse event occurring as a result of exposing implantable or wearable electronic medical devices to radiation during a CT scan was extremely low and that the clinical benefit of a medically indicated CT examination greatly outweighed the potential risk.…”