Medical-Imaging Companies To Increase Safeguards on Devices

More Radiation Overdoses Reported In Missouri

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Medical-Imaging Companies To Increase Safeguards on Devices

The Medical Imaging & Technology Alliance (MITA) which according to its web site represents companies whose sales comprise more than 90 percent of the global market for medical imaging technology announced yesterday that they "will add a color-coded warning system to give health care providers clear warning when they are doing scans that give patients potentially dangerous doses of radiation", according to Reuters and other news reports.

The MITA announcement comes one day before the US House of Representatives Energy and Commerce Committee's Subcommittee on Health is to hold a hearing that is going to examine the benefits and risks of radiation use in medicine. The hearing was sparked by numerous reports over the past year of numerous patients receiving radiation overdoses by mistake because of operator errors, hardware or software errors, etc.

I blogged about the problem in January.

The new warning system will be in machines made by General Electric, Toshiba Corp, Hitachi Ltd, Siemens and Philips, and will be rolled out later this year.

According to Reuters, the new warning system will show "a yellow alert screen when the dose is higher than expected. It would also offer a red alert warning when a patient is about to be given a dangerous dose of radiation."

It may be just me, but I would have thought this would have been standard equipment a long time ago.

New machines sold will have the warning system in place while older machines will receive software upgrades to provide the agreed to changes.

Just this week, the New York Times which has been following this issue closely (see here, here and here) reported that 76 patients of the CoxHealth Hospital in Springfield, Missouri had been over-radiated over a course of five years. The over-radiation apparently occurred because the machine was originally improperly calibrated during its installation and the on-site imaging company representative did not catch the error.

Only two weeks ago, the US Food and Drug Administration announced "an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy."  The FDA is becoming concerned that patients are being unnecessarily exposed to radiation.

As noted by Reuters, CTscans expose a patient to more than 100 times the radiation dose of a typical chest X-ray. In 1980, there were some 3 million CT scans performed in the US while there were 70 million scans performed in 2007.

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