Dental X-ray machines are FDA-regulated medical devices. As such, most states throughout the United States require that dental and dental specialty practices register their facilities and dental X-ray equipment through their state Department of Health or X-ray Programs. X-ray registration helps states maintain and protect the health and safety of the practice staff and patients through initial approvals (if required) and routine periodic inspections of the X-ray equipment. If practices fail to register their facilities and/or their X-ray machines, then states cannot properly ensure the safety of its constituents. Failure to register X-ray facilities and devices with the state in a timely manner can result in serious violations and civil penalties for the doctor and the practice.
Each state has its own requirements for dental X-ray machine registrations. These rules can be found on most state Department of Health or X-ray Program websites. Most states still require paper forms for filing X-ray facility and X-ray machine registrations, but we have seen an increase in online registration protocols in recent years. X-ray installers typically provide FDA 2579 Reports of Assembly to practices, the federal government and the state documenting each X-ray installation. These forms do not register X-ray machines with federal and state agencies. Instead, they provide the X-ray information and details that practices need to complete state registrations.
New Dental X-Ray Facility Registrations
When a practice wishes to obtain a dental X-ray machine for the first time, whether adding an X-ray to an existing practice or constructing a new office, many states require that they first register the practice as an X-ray facility. In these circumstances, the practice typically lists the X-ray equipment they are purchasing along with their practice information on their registration forms. That way, the facility and the X-ray equipment is registered at the same time.
X-ray facility registration guidelines and timelines differ significantly across state lines. Many states (including Texas, Georgia, Colorado, New York, South Carolina, and Washington) require that practices register their facilities prior to the installation of their first dental X-ray machine. Other states (such as Vermont, Arkansas, Pennsylvania, and California) require that facilities register within 30 days after the X-ray machine has been installed. Some states (such as Florida, Louisiana, Oregon, and Wisconsin) do not require that the dental X-ray machine be registered before installation, but it must be registered before operation. It is very important that dental practices verify their state registration requirements and timelines well in advance of obtaining a dental X-ray machine so they can be adequately prepared.
When a practice submits their registration paperwork, the state typically assigns the facility a unique registration ID number and provides the practice with a Certificate of Registration. This is how the state recognizes each location for billing, monitoring, and inspection purposes. Most states require that dental practices hang their Certificate of Registration near the X-ray machine or somewhere clearly visible in their practice.
If a new registrant submitted their X-ray machine details along with their application, then the X-ray machine(s) listed will be associated with the facility registration ID as part of the initial registration. Some states record specific details of each X-ray machine, such as the model/manufacturer, type, model year, serial number(s), and installation date, while other states simply record the number of different types of X-ray units installed at the practice. For example, they may wish to know how many intraoral X-ray units, extraoral X-ray units, or cone beam systems a dental practice owns, regardless of X-ray make or model. Several states (such as Colorado and Indiana) that keep track of specific X-ray machines will provide a sticker to affix to each X-ray machine listing the facility registration number and the individual X-ray machine registration number. This is how each machine is identified for reporting and inspection purposes.
In states where a facility or an X-ray machine must first be registered before the X-ray is installed, it is unlawful for a dental X-ray machine installer to install the X-ray without first confirming that the practice and/or X-ray has been registered. These service providers can also receive violations and civil penalties from the state for installing X-ray machines in unregistered locations.
Existing Dental X-Ray Machine Registrations
If a dental or dental specialty practice that is already registered as an X-ray facility wishes to add a new X-ray machine or replace an existing X-ray machine, they must often register their new or replacement X-ray equipment with the state using separate forms and protocols. Again, these forms and guidelines can be found on the state Department of Health or X-Ray Program websites. Some states are more lenient with registration timeframes when adding or replacing existing X-ray units. For example, New Jersey, Colorado, and Alabama allow practices to register additional or replacement equipment within 30 days of installation. Utah requires registration within 14 days and Tennessee within 10 days. But, other states are far more strict. Iowa, Illinois, and New York, for example, require that additional or replacement X-rays be registered prior to installation. States such as Maine, Louisiana, and Florida require that practices register their X-ray before use. Some states such as Rhode Island and Delaware even want practices to contact them before making any X-ray changes at all. When adding new or replacement X-ray machines, be sure to include your state X-ray facility number on the forms for easy identification and proper record-keeping.
Similar to installing new dental X-ray machines, it is unlawful for X-ray service providers to install X-rays in states where pre-registration is required. States can levy violations and civil penalties to both service providers and practices alike for failure to follow X-ray registration rules and timelines.
Replacing or Disposing of Dental X-Ray Machines
With the emergence of more affordable digital imaging and cone beam technology, many practices are replacing obsolete analog and/or older model digital and cone beam dental X-ray machines with newer models. Some practices sell or donate their previous devices while others choose to dispose of them. Because X-ray machines are federally regulated, dental X-ray machines that are transferred to X-ray resellers, donated to other practices or agencies, or sold to other dental professionals must be reported to the state. Likewise, dental X-ray machines that are disposed of or recycled must also be reported to the state.
Most states require that paper or online forms be submitted containing the information such as manufacturer, model, type, and serial numbers from the removed or disposed X-ray machines, along with the information of the company, practice, agency, or recycler that has received the removed device. Some states require a Certificate of Destruction and other documentation from recyclers and/or X-ray service companies attesting that the X-ray was destroyed properly. It is always a good idea to take photos or record the details from the state-provided machine stickers before the X-ray machines are removed so that you have those machine-specific identifiers available for accurate reporting. Also, be prepared to list your X-ray facility registration number on your form submissions to make it easier for states to update your practice information.
It is very important to follow state guidelines and timelines for reporting X-ray removals and disposals. Check the state Department of Health or X-Ray Program websites for important removal details and forms. Just like X-ray installations, failure to report removed or disposed X-ray equipment in a timely manner can result in practice violations and civil penalties.
Renew Digital Can Help
As a registered service provider in all required US states, Renew Digital can help navigate dental and dental specialty practices through the complex and often confusing process of state X-ray registration. It is important that everyone in the process takes X-ray registration and regulations seriously as these programs help ensure practice and patient safety. Practices should make copies of all forms submitted to the state and all documents received from the state and X-ray service providers for their records. State inspectors will often request to see these documents during an inspection.
For questions about the X-ray registration process for your state, please visit your state’s Department of Health or X-Ray Program website or contact Renew Digital Support at 888-246-5611, and select option 3 for assistance.