Monday, February 13, 2012

FDA Moves Quickly On Illegal Handheld X-Rays

The spread of handheld devices in healthcare is not without its hiccups, as evidenced by the recent crackdown by the FDA on online sales of handheld X-ray units which do not comply with regulations. The units, shipped from outside the United States to U.S. dentists and vets, were not compliant with effectiveness standards of the FDA and may expose a patient to more radiation than the FDA permits (no patient was harmed according to the agency). X-ray units cleared by the FDA bear a permanent certification label/tag, a warning label, and an identification (ID) label/tag on the unit. This was not present in the questioned devices, which were noticed by the Washington State Department of Health and brought to the attention of the FDA.

"Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health.

There are several handheld x-ray systems that do comply with FDA regulations; one is the Aribex NOMAD

The spread of handheld devices will create different regulatory responses which Kalorama Information has monitored. Last year the agency hinted it would regulate new handheld apps as very low-level (Class I) designation. That kind of flexibility would be needed for the market for medical handheld and corresponding apps to grow. However, when the device can do harm or influence a diagnosis, the agency is likely to be more aggressive. Kalorama Information has detailed the markets for handhelds and x-rays in two recent reports:

Handhelds in healthcare:

X-Ray Markets: