Sean Reilly, ITN Publisher
Sean Reilly, ITN Publisher

Sean Reilly is healthcare brands group publisher (Imaging Technology News and Diagnostic and Interventional Cardiology) at Scranton Gillette Communications.
 

Blog | Sean Reilly, ITN Publisher | September 04, 2012

When Freight Train and Rocket Fuel Truck Collide…

Like an eyewitness to a freight train bearing down on a rocket fuel truck at a railroad crossing, I couldn’t avoid watching the ensuing carnage after two individuals who underwent positron emission tomography (PET) myocardial perfusion imaging (MPI) with CardioGen-82 (Rubidium Rb 82 Generator) triggered airport radiation sensors in May 2011. Hung up on the tracks… Bracco Diagnostics, healthcare providers and their patients. Inbound at 60 miles-per-hour and weighing in at 15,000 tons… the U.S. Food and Drug Administration (FDA).  

One thing was certain from the start: The wreckage was going to be extensive.

In July 2011, after learning of the unexpected radiation exposure of the two patient-travelers, Bracco initiated a voluntary recall and ceased shipment of CardioGen-82 and launched an extensive investigation of the root cause. In the months that followed, additional steps to ensure patient safety were taken, including initiation of a Clinical Assessment Program of customers who administered CardioGen and an Rb82 Generator Quality Review Program. At the FDA’s request, Bracco initiated re-qualification of all CardioGen components and revalidated the manufacturing process. While jumping through flaming hoop after flaming hoop, Bracco representatives communicated openly with the FDA and encouraged their customers to do the same.

In January 2012, the FDA issued preliminary findings on the CardioGen investigation that included two significant points: (1) “Improper use” of CardioGen-82 at clinical sites was responsible for the increased radiation exposure to the patient-travelers, and (2) “It is unlikely this excessive exposure posed significant risks...” 

So, case closed/end of story?  Can a freight train traveling at 60 miles-per-hour stop on a dime (or on $100 million dollars)? 

One would think, with CardioGen-82’s successful track record (zero adverse events reported since its introduction in 1989) and the fact that all recalled generators were found to be working within specifications — plus the facts that “improper use” by two private practices caused the problem, the dose patients received was likely comparable to that of similar studies done in other modalities and Bracco Diagnostics acted in good faith throughout the process, sacrificing somewhere in the neighborhood of $100 million in revenue loss during this time — that common sense might prevail at the FDA, right?  Not exactly.

In August 2012, Bracco Diagnostics issued a customer letter outlining its agreement with the FDA and the phased reintroduction of CardioGen-82.  Included are the following planning initiatives:

• All sites must complete the respective training and knowledge assessments.

• All sites resuming PET myocardial perfusion imaging must have Bracco technical expertise onsite for the first two days of generator utility. Subsequent daily reporting review by the Bracco technical expert is also required.

• Generator shipments and resource deployment is aligned to optimize customer and Bracco compliance.

• Customers must complete and submit daily quality control (QC) reporting.

• Bracco QC monitoring occurs on a daily basis. Bracco and the customer follow up as appropriate.

To this observer, it looks like that freight train just backed up to roll over the rocket fuel truck a second time.

So, are there any winners here? Healthcare providers have not been able to offer their patients PET MPI scans for roughly a year. Now, they’re faced with more red tape, more regulation, more paperwork and drastic delays in getting their PET MPI programs up and running again.  Bracco Diagnostics has been saddled with the enormous burden and staggering cost of proving (for a second time) that CardioGen is safe when used properly. It has to win back lost customers.  Further, it must now take on the additional cost of maintaining a quality control data repository and monitoring program of its customers. For CardioGen to remain commercially viable, this cost is going to be passed along to customers, to patients and to payors. 

In business schools throughout the United States, “Freight Train vs. Rocket Fuel Truck” might someday become a case study of what is wrong with the healthcare system in the United States.  It should.

Related Content

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Example of full-dose, 10 percent low-dose and algorithm-enhanced low-dose. Image courtesy of Enhao Gong, Ph.D.

Feature | Contrast Media Injectors | April 11, 2019 | By Jeff Zagoudis
One of the most controversial issues in radiology in recent years has been the use of...
Videos | RSNA | April 03, 2019
ITN Editor Dave Fornell takes a tour of some of the most interesting new medical imaging technologies displa
Four of the top pieces of content in March included news on proton therapy, including a 360 image and videos from ITN's recent visit to the Northwestern Medicine Proton Center in the Chicago suburbs. This image shows the main proton treatment room gantry at the proton center in Warrenville, Ill. Interview with Mark Pankuch, Ph.D.

Four of the top pieces of content in March included news on proton therapy, including a 360 image and videos from ITN's recent visit to the Northwestern Medicine Proton Center in the Chicago suburbs. This image shows the main proton treatment room gantry at the proton center in Warrenville, Ill.
 

Feature | April 02, 2019 | Dave Fornell, Editor and A.J. Connell
April 2, 2019 — Here is the list of the most popular content on the Imaging Technology News (ITN) magazine w
NIH Study of Brain Energy Patterns Provides New Insights into Alcohol Effects

NIH scientists present a new method for combining measures of brain activity (left) and glucose consumption (right) to study regional specialization and to better understand the effects of alcohol on the human brain. Image courtesy of Ehsan Shokri-Kojori, Ph.D., of NIAAA.

News | Neuro Imaging | March 22, 2019
March 22, 2019 — Assessing the patterns of energy use and neuronal activity simultaneously in the human brain improve
At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve).

At #ACC.19, Siemens unveiled a version of its go.Top platform optimized for cardiovascular imaging. The newly packaged scanner can generate the data needed to do CT-based FFR (fractional flow reserve). Photo by Greg Freiherr

Feature | Cardiac Imaging | March 22, 2019 | By Greg Freiherr
Reflecting a trend toward the increased use of...
Improving Molecular Imaging Using a Deep Learning Approach
News | Nuclear Imaging | March 21, 2019
Generating comprehensive molecular images of organs and tumors in living organisms can be performed at ultra-fast speed...
PET Scans Show Biomarkers Could Spare Some Breast Cancer Patients from Chemotherapy
News | PET Imaging | March 18, 2019
A new study positron emission tomography (PET) scans has identified a biomarker that may accurately predict which...
SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram.

SyncVision iFR Co-registration from Philips Healthcare maps iFR pressure readings onto angiogram. Results from an international study presented at #ACC19 show that pressure readings in coronary arteries may identify locations of stenoses remaining after cardiac cath interventions.

Feature | Cardiac Imaging | March 18, 2019 | By Greg Freiherr
As many as one in four patients who undergo cath lab interventions can benefit from a technology that identifies the
Non-Contrast MRI Effective in Monitoring MS Patients
News | Neuro Imaging | March 18, 2019
Brain magnetic resonance imaging (MRI) without contrast agent is just as effective as the contrast-enhanced approach...