Late Breaking News
Death at Bronx VAMC Leads to Nationwide Recall of Nuclear Medicine Equipment
By Sandra Basu
WASHINGTON - An investigation is ongoing “to determine a definitive cause” of an accident in which a veteran died from injuries sustained when a portion of a nuclear medicine system fell during a scan, according to the VA.
The incident, which took place in June at the James J. Peters VA Medical Center, Bronx, NY, involved the GE Healthcare’s Infinia Hawkeye 4.
“The James J. Peters VA Medical Center is fully cooperating with VA's Office of the Inspector General and the camera’s manufacturer. VA will provide information as it becomes available. This is a very tragic and unusual event. Our first concern is for our veteran patient and his family,” VA said in a written statement.
In the wake of the incident, GE Healthcare initiated a Class I recall of several of its nuclear medicine systems. While saying the investigation was ongoing, GE Healthcare said the accident at the Peters VAMC was caused by loose bolts that failed to secure the camera.
“Bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident,” a July 3 GEHC letter to users of the equipment stated. “The safety concern is related to a potential patient entrapment or crush hazard if the camera falls during a patient exam.”
According to a Food and Drug Administration alert, the “nuclear medicine systems are used to perform general nuclear medicine imaging procedures for detection of radioisotope tracer uptake in the patient’s body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in oncology, cardiology, neurology and other clinical diagnostic imaging applications.”
Gary L Dillehay, MD, FACNM, FACR, who serves as president of the Society of Nuclear Medicine and Molecular Imaging (SNMMI), told U.S. Medicine that these types of systems provide very detailed images, allowing providers to localize abnormalities. He called the accident “extremely unusual,” and said he knew of only on other incident several years ago in which a patient was killed in any relation to nuclear medicine equipment.
GE Healthcare Recall
A GE Healthcare spokesman told U.S. Medicine that at the time of the incident, the piece of equipment was not under a service contract with GE.
GEHC said it was made aware of the patient’s death on June 5, the day of the incident, and was permitted access to the equipment on June 17. That same day, an Urgent Medical Device Correction letter was sent to all affected customers regarding the Infinia Hawkeye 4.
That letter recommended that “qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling.” In addition, the letter stated that the Safety Chapter Sections “should be re-reviewed with personnel to ensure proper operation of the equipment.”
On July 3, GE notified hospitals of the recall of several nuclear medicine imaging systems, stating in a letter, “Serious injuries or deaths could occur due to the failure mode associated with this recall.”
Because of the similarities between the design of Infinia Hawkeye 4 and other systems, GE included in its recall “all types and manufacturing dates of Infinia and Infinia Hawkeye nuclear medicine systems; all types and manufacturing dates of VG and VG Hawkeye nuclear medicine systems; and all types and manufacturing dates of Helix nuclear medicine systems by Elscint Ltd.”
“In this letter, we are adding the Brivo NM615, Discovery NM630, Optima NM/CT640, Discovery NM/CT670 to the notification due to similarities in basic mechanical concepts between these devices and the Infinia systems,” the letter stated.
That letter also recommended that customers stop using their nuclear medicine system until an inspection of their system is conducted.
“Healthcare facilities are instructed to cease use of their nuclear medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost,” the letter stated. “A GE Healthcare representative will contact the hospitals to arrange for the inspection.”
A spokesperson from GEHC said in mid-August that its inspections were nearly complete.