GE HealthCare reassures customers its contrast supply is stable following recall
Word of another potential contrast shortage began circulating through radiology departments weeks ago, but GE HealthCare is reassuring its customers that a shortage is not on the horizon.
On May 7, the World Health Organization issued a Medical Product Alert for multiple batches of contrast solutions manufactured by GE HealthCare. The alert pertained to Accupaque, Omnipaque and Visipaque solutions offered in 100 ml polypropylene containers and produced at the company’s facility in Cork, Ireland.
The alert was issued after the Health Products Regulatory Authority (HPRA), Ireland, notified WHO of a Class 1 quality defect. The defect refers to the possibility of “metallic particulate matter, either adhered to or embedded within the inner surface of polypropylene bottles.” The issue was not with the contrast itself, but with the bottles it was packaged in. If injected, the presence of particulate matter in the solution could cause life-threatening embolic events.
GEHC discovered at least one instance of free metallic particulate in a finished product, prompting it to take action and alert the appropriate health officials. It should be noted that there have been no adverse events reported in relation to the contaminated bottles.
Inevitably, this caused some temporary hiccups in the supply chain of iodinated contrast. However, a spokesperson with GEHC has offered reassurance that the issue was short lived and it’s back to business as usual at the Cork facility.
“Patient safety is our top priority. When GE HealthCare became aware of a manufacturing issue with a bottle supplier which is now resolved, we acted swiftly to leverage our second supplier and report it to regulatory authorities," an emailed statement to Radiology Business notes. "In most cases, we are meeting customer demand with alternative [stock keeping units] which are not impacted.”
Since the COVID-induced global shortage of iodinated contrast occurred in 2022, GEHC has taken steps to ensure its supply chain is not vulnerable to disruption. The company has invested tens of millions of dollars into expanding partnerships and ramping up production at numerous manufacturing locations globally.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.