CoxHealth announces some BrainLAB stereotactic radiation therapy patients received increased radiation dose

Feb. 24, 2010, Springfield, MO - CoxHealth today announced that it has discovered that 76 patients who had received a very specific type of treatment for brain tumors and other difficult-to-treat conditions using its BrainLAB stereotactic radiation therapy system, were accidentally exposed to radiation in amounts that exceeded the intended, therapeutic dose. The average variation of all the treatments of the 76 patients exceeded the prescribed dose by approximately 50 percent. A variation on the delivered dose of up to 10 percent is not significantly different than the prescribed dose and is considered no more risky than the prescribed treatment.

The BrainLAB stereotactic system utilizes a high dose of precisely targeted radiation to be delivered to smaller areas within the brain and other organs in the body, minimizing damage to surrounding tissues. This treatment is called stereotactic radiation therapy.

"In the simplest of terms, when the BrainLAB stereotactic system was put into service in 2004, we believe that the CoxHealth chief physicist responsible for initially measuring the strength of the radiation beam and gathering the data used to calibrate the equipment, chose the wrong measurement device - called a chamber," said John Duff, MD, senior vice president of hospital operations. "The area radiated is called the 'field size.' For these small tumors, the area radiated is referred to as a 'small field size.' The calibration error affected those patients who had treatment of very small field sizes."

"This is a very complex process, and unfortunately in spite of this physicist's experience and training, an error was made," said Duff.

"We are deeply sorry for our error and how it has affected these patients and their families. CoxHealth takes full responsibility and is doing all we can to care for and support our patients and their families," said Robert Bezanson, president and CEO of CoxHealth.

The chief physicist who made the initial calibration error is no longer working for CoxHealth.

"Because no patients during this time period were observed to have symptoms of increased radiation exposure, there was no prompt for CoxHealth to investigate any possible problems. It was only when a second CoxHealth physicist received training on BrainLAB stereotactic treatment in September 2009, did it enable us to question if the initial programming calibration was calculated correctly. At that point, we stopped accepting new patients into the BrainLAB stereotactic program, and began an internal investigation," said Duff.

"We knew we needed to re-measure the strength of the radiation beam in order to ensure that the radiation doses given to future patients were correct, and to calculate the actual doses previously received by our patients. We re-measured and recalibrated the BrainLAB stereotactic equipment and confirmed that the machine was recalibrated correctly for all treatment field sizes, with the exception of the very small treatment field sizes - 1.1 cm and smaller, or about the size of a pea.  Because of these findings, we were comfortable resuming BrainLAB stereotactic treatments with the larger treatment field sizes," Duff continued. "Therefore, we resumed treatments for larger field sizes in November 2009. However, because of our desire to err on the side of caution, we hired an outside physics group to confirm our internal measurements and recalibration of the BrainLAB stereotactic equipment. This group agreed with our calibrations and helped us examine and resolve our questions about the small field treatment sizes. This gave us the verified calibration data to begin our recalculation of past patients' doses. It was at this time that we found several cases where the variance between the radiation dose received, and that prescribed, had exceeded the amount we considered to be in the therapeutic range."

"We immediately suspended the BrainLAB stereotactic program for all patients, and to determine the actual amount of radiation received, we hired an outside physics expert to begin an independent re-analyses of all 152 patient cases treated in the BrainLAB stereotactic program since its start in 2004. We received the majority of the results on Feb. 16, and immediately began calling patients to request in-person meetings to notify them of their results. Again, we did not accept any new patients requiring small field size treatments, after our first suspicions in September 2009," said Duff.

In addition to the 76 BrainLAB stereotactic patients who received treatment that exceeded the prescribed dose by 10 percent or more, CoxHealth believes that the remaining 76 received exposure that was considered to be within the therapeutic range. These 152 patients are the sum total of all patients treated by the BrainLAB stereotactic equipment since its start in 2004, and they constitute only about one half of one percent of the total radiation oncology treatments performed by CoxHealth.

"It is important that our patients and the community understand that our error was isolated to only our BrainLAB stereotactic treatments. The vast majority of our patients in radiation oncology receive external beam radiation treatments, which are different than BrainLAB stereotactic treatments. The BrainLAB stereotactic system error also has no relation to the routine diagnostic tests we perform every day that use radiation, such as X-rays and computed axial tomography (CT) scans, nor does it affect any other cancer or related treatments involving radiation. Many patients receive other types of radiation treatment at CoxHealth; the BrainLAB stereotactic equipment calibration error is isolated to one very specific type of radiation treatment for a small category of brain tumors," said Bezanson.

What CoxHealth has done as a result:

 

What CoxHealth has done as a result:

 

  • Since it received the results of the independent expert's analysis, CoxHealth has attempted to contact by phone or letter (if phone contact has been unsuccessful) all patients to notify them of the error and explain its plan for taking full responsibility. CoxHealth has attempted (and is attempting) to have in-person meetings with as many patients and families as possible. It is also in the process of contacting the families of deceased patients to provide them with the same information.

"We were unable to complete our notifications to all patients and families before the media inquiry we received, although that was our plan," said Duff. "It's simply the right thing to do. Our intent was to always do a public announcement after speaking to and assisting our first priorities - our patients. "

 
  • CoxHealth has also communicated with the patients who received radiation within what is considered the therapeutic range.
  • In the cases of patients who have died, CoxHealth has attempted (or is in the process of attempting) to meet with or communicate with their family members.

In many of the cases, the tumors these patients had were very serious, and many of the patients had a poor prognosis when they began this treatment. CoxHealth's review of patient records is ongoing and not yet complete, so they indicate that it is premature to say if the overexposure had any impact on their current health condition, or if deceased, if it had any contributing factor to their deaths.

 
  • CoxHealth has also dedicated a special team of nurse coordinators to assist patients and families of patients who have received the BrainLAB stereotactic therapy and who may have questions or need assistance. They have established a call center line for them at 417-269-5363 or an e-mail contact at [email protected].
  • CoxHealth will pay for all additional follow-up exams, testing, support and treatment recommended by the affected patients' radiation oncology physicians, as a result of the overexposure they've received.
  • CoxHealth has implemented a special Safety Assurance Technology initiative as a result of this situation and has reached out to agencies interested in improving radiation safety and reporting.
"Our BrainLAB stereotactic system remains suspended indefinitely while we are auditing the entire program. We have also taken this situation to heart. It's unacceptable to us that an error like this occurred and we are taking steps to make sure that an error like this doesn't happen again," said Bezanson. "Therefore we have implemented a system-wide "Safety Assurance Technology" initiative, in which we are checking - and double-checking - ALL of the technology and equipment used in not only the radiation oncology department, but also our radiology and surgical services. These three areas are where most of our life-saving technology is concentrated, and we want to assure our patients and ourselves that an inadvertent human error won't impact people in this manner again."
 

"We also have reported this incident to the national hospital accreditation agency, the Joint Commission. There is no federal agency, nor is there any agency in the state of Missouri that requires reporting of radiation overexposure. Some states have reporting agencies and others do not. Missouri does not," he said.

Duff said, "This is a very complex area of technology. We are going to reach out to the Food and Drug Administration, even though there is no one there to disclose to, offering our support of their initiatives to strengthen radiation reporting and safety. We also will attempt to work with our lawmakers and other hospitals that have been faced with similar situations to see how we can be a part of the solution to prevent this from happening to other hospitals and patients in the future."

Bezanson concluded, "In closing, we know that our radiation oncology service provides life-saving treatments to hundreds and hundreds of patients each year, and there are many who can say, 'CoxHealth saved my life.' We are committed to ensuring beyond a doubt, that this program, and our many other services that use the most complex of life-saving technology, are safe, and will continue to be, in the future."

CoxHealth Corporate Communications
Phone: 417-269-4113 | Fax: 417-269-5750
After business hours: 417-269-3211

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