Source: NY Times
Author: Walt Bogdanich

GAITHERSBURG, Md. — Manufacturers of radiation therapy equipment said at a patient-safety conference here Wednesday that within the next two years their new equipment and the software that runs it would include fail-safe features to help reduce harmful radiation overdoses and other mistakes.

The absence of these fail-safe features contributed to the fatal radiation overdose of a New York City patient, whose death was the centerpiece of a lengthy article in The New York Times early this year that examined radiation accidents and how complex new technology contributed to those accidents.

Two associations representing the biggest manufacturers of radiotherapy equipment said their equipment — including linear accelerators, which generate high-powered beams of radiation — will shut down if it does not detect that the treatment plan had been checked, that beam modifying devices were correctly placed and that the patient was properly positioned.

Most machines are currently configured so that quality-assurance checks are at the discretion of the user, said David Fisher, executive director of Medical Imaging and Technology Alliance, one of the industry groups.

The conference, convened by the Food and Drug Administration to discuss ways to reduce radiation overdoses, underdoses and misaligned exposures, was attended by regulators, technicians, medical physicists, doctors and vendors.

Several speakers said that articles in The Times about radiation errors, particularly one on the death of Scott Jerome-Parks, a 43-year-old computer programmer, were the impetus for much of the discussion on how to make radiation therapy safer. “The recent attention to radiation dose issues has made the user base more receptive to these types of verification procedures,” Mr. Fisher said.

Mr. Jerome-Parks died after receiving a huge overdose on three separate occasions because of software glitches and user error. Quality-control checks that would have detected the error were not made until three days after he began receiving a modified treatment plan for tongue cancer.

Dr. Simon Choi, network leader for radiological products at the F.D.A., praised the manufacturers for taking the step, but said questions remained about how quickly the changes would be made and whether older radiotherapy machines could be outfitted with the new software.

Several medical physicists said in interviews that they were reserving judgment until they saw the specific changes. “How it is implemented would make a big difference,” said Dr. Bruce Thomadsen, a medical physicist at the University of Wisconsin.