OEMs agree with end-users on the need for a national reporting system. Device companies are required to report errors through MAUDE (Manufacturer and User Facility Device Experience), an FDA-maintained database of adverse effects.
“Manufacturers are mandated to report issues and respond to those issues within 24 hours. Hospitals, however, are not obligated to do that,” says Elekta’s Prosser. “We would like to see hospitals under the same requirement.”

However, the concept of a national error reporting mechanism, whether voluntary or mandatory, could get tricky when it comes to potential legal action.
“How do you keep malpractice plaintiff attorneys from having access to that information and using it as a way to develop malpractice suits?” asks Hendee.

“That’s a great inhibition of reporting, so it needs to be worked through.”
Hendee says the industry should also place a bigger emphasis on failure mode and effects analysis and root cause analysis.

“We need to know why those mistakes are made and how we can keep them from being made again,” he says.

Talk of accreditation

The idea of accreditation for facilities that provide radiation therapy treatment is also floating around the industry. Some professionals suggest that accreditation should be tied to reimbursement and others look to the Radiological Physics Center as a potential accreditation body.

Housed at the M.D. Anderson Cancer Center in Houston, Texas, RPC designates centers as qualified participants in the National Cancer Institute cooperative clinical trials by evaluating a facility’s ability to safely and effectively deliver radiation.

“I think some of us believe, definitely myself included, that a facility should be credentialed in order to deliver these types of very complex treatments, regardless of whether they are putting patients on clinical trials,” says Dr. Jay Burmeister, chief of physics for Karmanos Cancer Center in Detroit, Mich. “I’m not sure how we go about that, if insurance agencies should require facilities to participate in a RPC test before they reimburse for this, but I think it would definitely be advantageous for us to require facilities to be credentialed before they deliver this technology to patients. The amount of time put into participating in these tests is relatively small with respect to the amount of time that you spend commissioning this technology.”

About 30 percent of facilities across the U.S. are failing one of RPC’s intensity-modulated radiation therapy tests. The number may be misleading, explains Burmeister, because the test is administered largely at prominent institutions.

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