Saturday, January 23, 2010

Computers + radiation therapy = a potentially deadly combination

Wow, I just read a frightening article in the New York Times about a rash of computer programming errors that have led many patients undergoing high-tech radiation therapy for cancer to be massively--sometimes fatally--overdosed.

One example:
Shortly after 11 a.m., as Ms. Kalach [a medical physicist at St. Vincent's hospital in New York City] was trying to save her work, the computer began seizing up, displaying an error message. The hospital would later say that similar system crashes “are not uncommon with the Varian software, and these issues have been communicated to Varian on numerous occasions.”

An error message asked Ms. Kalach if she wanted to save her changes before the program aborted. She answered yes. At 12:24 p.m., Dr. Berson approved the new plan.

Meanwhile, two therapists were prepping Mr. Jerome-Parks for his procedure, placing a molded mask over his face to immobilize his head.

Then the room was sealed, with only Mr. Jerome-Parks inside.

At 12:57 p.m. — six minutes after yet another computer crash — the first of several radioactive beams was turned on.

The next day, there was a second round of radiation.

A friend from church, Paul Bibbo, stopped by the hospital after the second treatment to see how things were going.

Mr. Bibbo did not like what he saw. Walking into a darkened hospital room, he recalled blurting out: “ ‘My goodness, look at him.’ His head and his whole neck were swollen.”

Anne Leonard, another friend, saw it, too, on a later visit. “I was shocked because his head was just so blown up,” Ms. Leonard said. “He was in the bed, and he was writhing from side to side and moaning.”
Concerned about the problem, the medical physicist checked the system's treatment program for the patient:
On the afternoon of March 16, several hours after Mr. Jerome-Parks received his third treatment under the modified plan, Ms. Kalach decided to see if he was being radiated correctly.

So at 6:29 p.m., she ran a test to verify that the treatment plan was carried out as prescribed. What she saw was horrifying: the multileaf collimator, which was supposed to focus the beam precisely on his tumor, was wide open.

A little more than a half-hour later, she tried again. Same result.

Finally, at 8:15 p.m., Ms. Kalach ran a third test. It was consistent with the first two. A frightful mistake had been made: the patient’s entire neck, from the base of his skull to his larynx, had been exposed.

Early the next afternoon, as Mr. Jerome-Parks and his wife were waiting with friends for his fourth modified treatment, Dr. Berson unexpectedly appeared in the hospital room. There was something he had to tell them. For privacy, he took Mr. Jerome-Parks and his wife to a lounge on the 16th floor, where he explained that there would be no more radiation.

Mr. Jerome-Parks had been seriously overdosed, they were told, and because of the mistake, his prognosis was dire.

Stunned and distraught, Ms. Jerome-Parks left the hospital and went to their church, a few blocks away. “She didn’t know where else to go,” recalled Ms. Leonard, their friend.

The next day, Ms. Jerome-Parks asked two other friends, Nancy Lorence and Linda Giuliano, a social worker, to sit in on a meeting with Dr. Berson and other hospital officials.

During the meeting, the medical team took responsibility for what happened but could only speculate about the patient’s fate. They knew the short-term effects of acute radiation toxicity: burned skin, nausea, dry mouth, difficulty swallowing, loss of taste, swelling of the tongue, ear pain and hair loss. Beyond that, it was anyone’s guess when the more serious life-threatening symptoms would emerge.

“They were really holding their breath because it was the brain stem and he could end up a paraplegic and on a respirator,” Ms. Giuliano said.

Ms. Lorence added: “I don’t really think they expected Scott to live more than two months or three months.”
In the end, he died two years later. While there were problems with the computer software designed by Varian to control the system, operators missed a variety of warning that should have alerted them to problems:
When the computer kept crashing, Ms. Kalach, the medical physicist, did not realize that her instructions for the collimator had not been saved, state records show. She proceeded as though the problem had been fixed.

“We were just stunned that a company could make technology that could administer that amount of radiation — that extreme amount of radiation — without some fail-safe mechanism,” said Ms. Weir-Bryan, Ms. Jerome-Parks’s friend from Toronto. “It’s always something we keep harkening back to: How could this happen? What accountability do these companies have to create something safe?”
Disturbingly:
Even with this special protection, the strongest in the country, many radiation accidents go unreported in New York City and around the state. After The Times began asking about radiation accidents, the city’s Department of Health and Mental Hygiene reminded hospitals in July of their reporting obligation under the law. Studies of radiotherapy accidents, the city pointed out, “appear to be several orders of magnitude higher than what is being reported in New York City, indicating serious underreporting of these events.”

The Times collected summaries of radiation accidents that were reported to government regulators, along with some that were not. Those records show that inadequate staffing and training, failing to follow a good quality-assurance plan and software glitches have contributed to mistakes that affected patients of varying ages and ailments....

Fines or license revocations are rarely used to enforce safety rules. Over the previous eight years, despite hundreds of mistakes, the state issued just three fines against radiotherapy centers, the largest of which was $8,000.

Stephen M. Gavitt, who directs the state’s radiation division, said if mistakes did not involve violations of state law, fines were not proper. The state does require radiotherapy centers to identify the underlying causes of accidents and make appropriate changes to their quality-assurance programs. And state officials said New York had taken a leadership role in requiring that each facility undergo an external audit by a professional not connected to the institution.

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