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Device manufacturers call for radiotherapy safeguards

by Brendon Nafziger, DOTmed News Associate Editor | June 10, 2010
Safeguarding radiotherapy
Device manufacturers call for in-built safeguards for radiotherapy devices to prevent the sort of dosage mishaps that made headlines last year.

On Wednesday, industry lobbyists Medical Imaging and Technology Alliance and Advanced Medical Technology Association launched the Radiation Therapy Readiness Check Initiative.

Under this three-pronged plan, radiotherapy manufacturers will install safeguard features in the software of new systems, and upgrade certain compatible old ones, to prevent devices from operating if proper protocols aren't followed.

"The manufacturers have committed to begin working immediately on implementing the initiatives on new products, and also making them available on compatibly configured products in the install base in two years," David Fisher, executive director of MITA, told DOTmed News.

The initiative includes three items: One is a quality assurance mechanism, so machines won't run unless a doctor or medical physicist signs off on treatment. Another verifies that beam-modifying accessories like wedges, blocks and compensators are in place, and prevents the machine from operating if they're not. Finally, the devices will provide a visual image of the planned position of the patient relative to the treatment device, and require the operator to confirm by sight that the patient's position matches up to the one intended by the treatment plan.

The hurdles now are working with the U.S. Food and Drug Administration for approval on the coming updates.

"We've been working with the FDA on making sure these changes are either included in software releases without official clearance or to try to make sure we can get this cleared as quickly as possible," Fisher said. "I think all signs point to a positive direction."

Although the news of the launch came on the first day of the FDA's two-day meeting with industry, the public, and health care officials on improving the safety of radiotherapy devices, Arlington, Va.-based MITA said they had hoped to launch the initiative last week.

And so far, the radiotherapy meeting is "going well," said Fisher, who spoke at it Wednesday.

"I think it's important for all stakeholders to be included in whatever changes are going to take pace, because there are lots of reasons why medical errors occur, and you can't put the blame on one actor," he said.

The radiotherapy initiative is something of a follow-up to one launched earlier this year. In February, MITA launched a CT dose check initiative to ensure diagnostic scans delivered the appropriate dose.