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Would You Shop For X-ray Machines On eBay?

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Hey, somebody in Hong Kong is selling a “Handheld Portable Mobile Wireless Green X-Ray Unit Machine” on eBay, and it’s a pretty good deal. What could go wrong?

That apparently was the thinking of a dentist in Washington state, according to DOTmed News. It reported that a Food and Drug Administration alert last week about “Illegal Sale of Potentially Unsafe Hand-held Dental X-Ray Units” stemmed from an eBay purchase by a Washington dentist in August.

The FDA “safety communication” warned dentists, veterinarians, and other health care providers about the illegal online sale of foreign-made handheld dental X-ray devices that have not been reviewed by the FDA and therefore may be unsafe.

DOTmed News said that after the dentist’s eBay purchase, the dentist contacted the Washington State Department of Health to have the device inspected, per state regulations.

Inspectors visited the dentist’s office and found the device lacked a backscatter shield, leaked more radiation than normal, and failed operating voltage accuracy tests. Department spokesman Donn Meyer told DOTmed News:

It was outside of standards. We would call it not safe.

The Washington health department apparently notified the FDA. The FDA’s statement listed the certification, warning, and identification labels that all approved devices must bear. In case of any doubt, it suggested checking with the FDA Medical Device Approvals and Clearances searchable database.

In other safety news, another FDA safety communication this week revealed that Bracco Diagnostics would be returning CardioGen-82 to the U.S. market. The device produces rubidium-82 chloride injections, used in PET heart scans.

As we’ve reported, it was recalled last July after three patients were found to have elevated levels of radiation months after undergoing PET stress tests. Last fall, Bracco said its investigation traced the problems to user error, strontium breakthrough, or both. If strontium-82, used by the generator to make rubidium-82, “breaks through” into the patient, it can cause elevated radiation levels.

The device now carries revised labeling, which includes new “Alert Limits” for strontium in the injection fluid. DOTmed News reported that the first new shipments of the generators went out, appropriately for a device used in heart scans, on Valentine’s Day.

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One Response to “Would You Shop For X-ray Machines On eBay?”

  1. Radiology Daily»AlertArchive » ‘The Bump’ Disrupts Cardiac PET Schedules on June 22nd, 2012 at 10:02 am

    […] The problem involves the CardioGen-82 machine, which produces the rubidium-82 radiotracer used in PET myocardial perfusion imaging. The CardioGen was pulled from the market last year when three patients were found to have elevated levels of radiation several months after PET stress tests. Bracco Diagnostics resumed shipping the CardioGen in February with a beefed-up warning. (See our earlier report here.) […]