Regulatory moves
The U.S. Food and Drug Administration also took note of radiotherapy safety concerns. In April, the agency sent letters to approximately 93 manufacturers to explain the measures it plans to take to improve the safety of radiotherapy devices and their use.

“The FDA is taking these steps to reduce the number of underdoses, overdoses and misaligned exposures from therapeutic radiation,” wrote Dick Thompson, an FDA spokesman, in an e-mail to DOTmed News. “These devices include linear accelerators, proton therapy systems, radiation therapy treatment planning systems and radiation therapy simulators.”
The FDA analyzed medical device reports and found that errors could be diminished if additional safeguards are incorporated. In the letter, the agency wrote that it received 1,182 MDRs associated with the use of radiation therapy devices between the winters of 1999 and 2010. Out of those MDRs, linear accelerators accounted for 74 percent of the adverse effects reports. Computer software issues, misuse of devices and incorrect display were some of the most commonly reported problems.

In the letter, the FDA also announced that it would no longer allow new radiotherapy devices to undergo a streamlined approval process using third-party reviewers.

“Ultimately, what that means is that new innovations will take longer to get to market,” says MITA’s Fisher. “FDA has a large load and as a result, the third-party review process often makes the process quicker for manufacturers and patients.”

The agency also held a public meeting in June and called for input on the steps that OEMs could take to help reduce the number of errors. Industry experts anticipate the agency taking additional action in the near future.

Reporting errors
Amidst discussions about radiation safety, the idea of a standardized, national system for reporting errors is generating a lot of buzz. Current error reporting requirements vary from state to state, says ASTRO’s Zietman. Some states, like Massachusetts, have rigid mechanisms in place, whereby state officials monitor and investigate patterned errors throughout health facilities. However, at least a dozen states have more lax policies. For instance, facilities in California aren’t required to report errors that involve linear accelerators to state health authorities.

“We need a national reporting system for medical errors, and even near misses. It happens in many states but it needs to happen nationally,” says Zietman.

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