Dive Brief:

• FDA issued a warning letter to Denterprise International, citing violations including failure to properly report complaints that patients were accidentally exposed to additional radiation. The agency asked the company to explain whether the exposures were due to device malfunction.
• The Oct. 9 warning letter, published online Tuesday, follows a series of inspections dating back to 2016 at the company’s operations in Ormond Beach, Florida, that uncovered deficiencies in the company’s complaint handling and reporting.
• FDA deemed inadequate a response from Denterprise in May in which the company said it met its minimum reporting requirements and revised its complaint reporting procedures.

Dive Insight:

Exposure to ionizing radiation can damage DNA and increase a person’s lifetime risk of developing cancer. While dental X-rays are among the imaging procedures that use relatively low amounts of radiation, FDA is concerned about cumulative exposure. In a white paper on reducing unnecessary radiation exposure, FDA said the National Council on Radiation Protection and Measurements found the U.S. population’s total exposure to ionizing radiation had nearly doubled over two decades.

In its warning letter to Denterprise, FDA said the company’s complaint records lacked required information including whether individuals were exposed to additional radiation due to a device malfunction. FDA said complaint records reviewed during its inspection revealed device malfunctions involving additional radiation exposures that were not reported to FDA.

FDA focused on three specific complaints in the company’s records. It found Denterprise did not report on an allegation that its QuickRay HD dental X-ray sensor device stopped without saving data, resulting in 16 additional radiation exposures affecting 12 patients. A second complaint of "grainy images" resulted in four additional exposures, and a third complaint of "white images" resulted in two additional exposures.

Denterprise said it met minimum reporting requirements for patient exposures to radiation, revised its complaint reporting procedures, increased the threshold for potentially injurious exposure, and would have its personnel review complaints and complete reports within 30 days of an incident. But FDA said the company’s responses were inadequate.

The agency asked Denterprise to conduct a retrospective review of all accidental radiation incidents and exposures. It gave the company 15 days to respond.

In addition to its concerns with the company’s radiation reporting, FDA said Denterprise failed to establish procedures to ensure vendors meet quality requirements and did not submit evidence it evaluated its current suppliers.  

FDA also found fault with Denterprise’s procedures covering design requirements for its FlashRay dental X-ray sensor device and said the company failed to maintain device history records for both the FlashRay and MobileX Model T-100 devices.